Court filing
Appendix in Support of Brief for Timely Production — PHMPT v. FDA
Filed December 7, 2021 in Public Health and Medical Professionals for Transparency v. Food and Drug Administration; one of 30 filings from this case.
Record facts
| Court | U.S. District Court for the Northern District of Texas |
|---|---|
| Filed | 2021-12-07 |
U.S. District Court for the Northern District of Texas · No. 4:21-cv-01058-P · Doc. 27 · 2021-12-07 · Docket on CourtListener
Full text
Page 1 of 2
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF TEXAS
PUBLIC HEALTH AND MEDICAL
PROFESSIONALS FOR TRANSPARENCY,
Plaintiff,
-against-
FOOD AND DRUG ADMINISTRATION,
Defendant.
Civil Action No. 4:21-cv-01058-P
APPENDIX IN SUPPORT OF BRIEF FOR TIMELY PRODUCTION
NOW COMES, Plaintiff Public Health and Medical Professionals for Transparency and
files this Appendix in Support of its Brief for Timely Production.
Exhibit
Description
Page No.
A
Declaration of Peter McCullough, MD, MPH,
President of Public Health and Medical Professionals
for Transparency (PHMPT)
App000001 –
App000003
B
Declaration of Harvey Risch, MD, PhD
App000004 –
App000102
C
Declaration of Tom Jefferson, MD MRCGP FFPHM
App000103 –
App000150
D
Declaration of Peter McCullough, MD, MPH
App000151 –
App000336
E
Declaration of Aaron Siri, Esq.
App000337 –
App000579
Unpublished Cases
App000580 –
App000631
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 1 of 633 PageID 727
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 1 of 633 PageID 727
Page 2 of 2
Dated: December 7, 2021
SIRI & GLIMSTAD LLP
Aaron Siri, NY Bar No. 4321790
Elizabeth A. Brehm, NY Bar No. 4660353
Gabrielle G. Palmer, CO Bar No. 48948
200 Park Avenue
New York, New York 10166
Tel: (212) 532-1091
Fax: (646) 417-5967
aaron@sirillp.com
ebrehm@sirillp.com
gpalmer@sirillp.com
HOWIE LAW, PC
John Howie
Texas Bar Number: 24027239
2608 Hibernia Street
Dallas, Texas 75204
Tel: (214) 622-6340
jhowie@howielaw.net
Attorneys for Plaintiff
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 2 of 633 PageID 728
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 2 of 633 PageID 728
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 5 of 633 PageID 731
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Exhibit %
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 6 of 633 PageID 732
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 6 of 633 PageID 732
App000005
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 7 of 633 PageID 733
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 7 of 633 PageID 733
App000006
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 8 of 633 PageID 734
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 8 of 633 PageID 734
App000007
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 9 of 633 PageID 735
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 9 of 633 PageID 735
App000008
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 10 of 633 PageID 736
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 10 of 633 PageID 736
App000009
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 11 of 633 PageID 737
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 11 of 633 PageID 737
App000010
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App000011
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 13 of 633 PageID 739
App000012
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 14 of 633 PageID 740
Curriculum Vitae of Harvey A. Risch, M.D., Ph.D.
(Exhibit A to Risch Declaration)
App000013
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 15 of 633 PageID 741
Curriculum Vitae for: HARVEY A. RISCH, M.D., PH.D.
Professor of Epidemiology
Yale School of Public Health, Yale School of Medicine
Business Address:
Yale School of Public Health
60 College Street, LEPH 413
P.O. Box 208034, New Haven, CT 06520-8034
Phone: (203) 785-2848; Fax: (203) 785-4497
E-mail: harvey.risch@yale.edu
Education:
Date
School
Degree, Major
9/80-12/82
University of Washington
Postdoctoral Fellow, Epidemiology
9/76-8/80
University of Chicago
Ph.D., Biomathematics
9/72-6/76
UC San Diego School of Medicine M.D., Medicine
9/67-6/72
California Institute of Technology
B.S. (Honors), Biology; Mathematics
Professional Appointments:
7/01-
Professor of Epidemiology, Department of Chronic Disease Epidemiology, Yale
School of Public Health, Yale School of Medicine, New Haven, CT.
1/12-
Director, Molecular Cancer Epidemiology Laboratory and Shared Resource, Yale
Comprehensive Cancer Center and Yale School of Public Health
9/06-8/07
Lady Davis Visiting Professor, Department of Community Medicine and
Epidemiology, Faculty of Medicine, Technion-Israel Institute of Technology, Haifa,
Israel
1/91-6/01
Associate Professor of Epidemiology, Department of Epidemiology and Public
Health, Yale University School of Medicine.
1/83-12/90
Epidemiologist-Biostatistician, Epidemiology Unit, National Cancer Institute of
Canada, Toronto, Ontario.
7/90-12/90
Associate Professor, Department of Preventive Medicine and Biostatistics, University
of Toronto, Toronto, Ontario (Concurrent Appointment).
1/83-6/90
Assistant Professor, Department of Preventive Medicine and Biostatistics, University
of Toronto, Toronto, Ontario (Concurrent Appointment).
9/80-12/82
Postdoctoral Fellow, Department of Epidemiology, School of Public Health and
Community Medicine, University of Washington, Seattle, Washington.
7/79-8/80
Postdoctoral Fellow, Department of Pathology, University of Chicago, Chicago,
Illinois.
h-Index: 9. Publication citations: more than 4,000 research citations as of -XQH 22, 2021.
App000014
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 16 of 633 PageID 742
Awards, Memberships, etc.:
NSF Undergraduate Research Fellowship, Department of Mathematics, California Institute of
Technology, Pasadena (6/70-9/70)
General Medicine Stipended Externship, UC San Diego School of Medicine, La Jolla (6-9/73)
Theoretical Biology Predoctoral Traineeship, University of Chicago (9/76-6/79)
Pathobiology Postdoctoral Traineeship (GM 7190), University of Chicago (7/79-8/80)
Cancer Epidemiology Postdoctoral Traineeship (CA 9168), University of Washington (9/80-12/82)
Member, Society for Epidemiologic Research (1982- )
Member, American Society of Preventive Oncology (1984- )
Full Member, Sigma Xi (1986- )
Fellow, American College of Epidemiology (1991- ); Member (1984-91)
Member, Yale Cancer Center (1992- ), Sections: Cancer Prevention and Control; Gynecologic
Oncology; Cancer Genetics
“Best of the AACR Journals” for “Aspirin Use and Reduced Risk of Pancreatic Cancer,” one of
the most highly cited Cancer Epidemiology, Biomarkers & Prevention (CEBP) articles
published in 2016 (April 2018) ( http://aacrjournals.org/h-a-risch-bio )
The Ruth Leff Siegel Award for Excellence in Pancreatic Cancer Research (2018), $50,000
( http://columbiasurgery.org/pancreas/ruth-leff-siegel-award )
Member, Connecticut Academy of Science and Engineering (2019- )
Highest attention paper ever published in the American Journal of Epidemiology (2020)
(https://oxfordjournals.altmetric.com/details/82900954)
Consortia:
BEACON: Barrett's Esophagus and Esophageal Adenocarcinoma Consortium (2005- )
OCAC: Ovarian Cancer Association Consortium (International Consortium of Case-Control
Studies of Ovarian Cancer) (2005- )
PanC4: Pancreatic Cancer Case-Control Consortium (2006- ); Elected Steering Committee
Member (2008-2013, 2014-2017, 2018-2021)
Panscan: Pancreas Cancer Genome-wide Association Study Consortium (2008- )
CIMBA: Consortium of Investigators of Modifiers of BRCA1/2 (2017- )
Research Interests:
Cancer epidemiology and etiology—Pancreas, Ovary, Lung, Breast, Stomach, Bladder, etc.
Cancer genetic epidemiology: polymorphisms, major genes; Hormonal factors and cancer; Occupa-
tional/environmental exposures and cancer; Diet and cancer; Helicobacter pylori and cancer
Epidemiologic methods; Causal inference; Cancer registration, control and prevention
Teaching Experience:
Advanced Epidemiologic Research Methods (Yale University CDE 619a) (Course developer)
Fundamentals of Epidemiology (Yale University CDE/EMD 508) (Course developer)
Principles of Epidemiology II (Yale University CDE 516) (Course developer)
Research Methods in Epidemiology I (University of Toronto CHL 4102f) (Course co-developer)
Research Methods in Epidemiology II (University of Toronto CHL 4105s) (Course developer)
Cancer Epidemiology (University of Toronto CHL 4103f; Yale University CDE 532b)
Trainees
PhD: Advisor to five students; dissertation committee member for 11 students.
MPH or MSc: Advisor to 36 students.
Postdoctoral Fellows: Advisor to 16 fellows.
App000015
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 17 of 633 PageID 743
Visiting Faculty: Host to four visiting professors.
Service Activity:
Grant Review Panels:
Health Canada, National Health Research and Development Program: Epidemiology,
Occupational Health and Chronic Disease Panel (1987-91)
NIH External Site Reviewer (1995)
NIH Study Section Regular Member: Epidemiology and Disease Control (EDC2) (1997)
US Army MRMC Ovarian Cancer Research Program Integration Panel Member (1997-2002)
American Cancer Society Extramural Grant Reviewer (1998)
Chair, Epidemiology Grant Review Panel, National Cancer Institute of Canada (2000-2)
Dutch Cancer Society Extramural Research Grant Reviewer (2000, 2001, 2008)
Cancer Council Australia Extramural Research Grant Reviewer (2004)
Pancreatic Cancer Action Network-AACR Career Development Awards Scientific Review
Committee (2016-8)
NIH Study Section Member: Epidemiology and Disease Control (EDC2) (2000)
NIH Study Section Member: Epidemiology Special Emphasis Panel (ZRG4, 1998; ZRG1, 2001-3)
NIH Study Section Member: Pancreas SPORE Panel (ZCA1 GRB-V, 2002-3)
NIH Study Section Member: Small Grants Program for Cancer Epidemiology Panel (ZCA1
SRRB-Q, 2003)
NIH Study Section Member: Cancer Genetics Panel (CG) (2004, 2006)
NIH Study Section Member: Cancer Epidemiology, Prevention and Control (NCI-E X1) (2005)
NIH Study Section Member: Breast and Ovarian Cancer Genetics (ZRG1 ONC-U 03M) (2005)
NIH Study Section Member: Gene-Environment Interactions (ZHL1 CSR-D S1 R) (2007)
NIH Study Section Member: Epidemiology of Cancer Member Conflicts (ZRG1 HOP-Q, 2009;
ZRG1 PSE-B, 2010)
NIH Study Section Member: Barrett's Esophagus Translational Research Network (ZCA1 SRLB-1
(O1) R, 2011)
NIH Study Section Member: Core Infrastructure and Methodological Research for Cancer
Epidemiology Cohorts (ZCA1 SRLB-9 (M2) B, 2013; ZCA1 TCRB-9 (J2) R, 2014; ZCA1
SRBJ (O2) S, 2015)
NIH Study Section Member: Cancer Management, Epidemiology, and Health Behavior (ZCA1
SRLB-B (J1) S, 2013)
NIH Study Section Member: Population Science (U01) (ZCA1 RTRB-Z M1 R, 2016)
Medical Research Council UK External Reviewer (2019)
Journal Editor:
Associate Editor, American Journal of Epidemiology (1997-2014)
Editor pro tem, American Journal of Epidemiology (2002-2014)
Member, Board of Editors, American Journal of Epidemiology (2014-2020)
Associate Editor, Journal of the National Cancer Institute (2000- )
Editor, International Journal of Cancer (2008- )
Journal Referee:
Alimentary Pharmacology & Therapeutics (2015- )
American Journal of Epidemiology (1986- )
American Journal of Medical Genetics (2004- )
American Journal of Obstetrics and Gynecology (2015- )
American Journal of Preventive Medicine (1988- )
App000016
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 18 of 633 PageID 744
Annals of Epidemiology (1992- )
Annals of Oncology (2001- )
Annals of Surgical Oncology (2011- )
Biodemography and Social Biology (2018- )
Biometrics (1990- )
Blood Transfusion (2015- )
BMC Cancer (2007- )
BMC Public Health (2007- )
British Journal of Cancer (2003- )
Canadian Journal of Public Health (1987- )
Canadian Medical Association Journal (1983- )
Cancer (1996- )
Cancer Causes and Control (1992- )
Cancer Detection and Prevention (2003-2009)
Cancer Epidemiology (2009- )
Cancer Epidemiology, Biomarkers and Prevention (1995- )
Cancer Genetics (2012- )
Cancer Research (1988- )
Carcinogenesis (2008- )
Clinical Cancer Research (2015- )
Clinical Gastroenterology and Hepatology (2007- )
Current Pharmacogenomics (2007- )
DNA and Cell Biology (2019- )
Environmental Pollution (2018- )
Epidemiology (1989- )
European Journal of Cancer (2001- )
European Journal of Epidemiology (1995- )
European Journal of Human Genetics (2008- )
Gastroenterology (2007- )
Gynecologic Oncology (1997- )
International Journal of Cancer (1995- )
International Journal of Epidemiology (1995- )
JAMA (1990- )
Journal for Nurse Practitioners (2018- )
Journal of Clinical Epidemiology (2006- )
Journal of Clinical Gastroenterology (2010- )
Journal of Clinical Medicine (2019- )
Journal of Epidemiology (2016- )
Journal of Infectious Diseases (2002- )
Journal of the National Cancer Institute (1992- )
Menopause (2011- )
Molecular Carcinogenesis (2009- )
Nature Clinical Practice Oncology (2005- )
Nature Scientific Reports (2016- )
New England Journal of Medicine (2017- )
Oncology Research (2001- )
Oncotarget (2017- )
Preventive Medicine (1994- )
App000017
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Reproductive Sciences (2008- )
Science (2004- )
Treatments in Endocrinology (2003- )
Tumor Biology (2015- )
World Journal of Gastroenterology (2013- )
Other Review and Service:
Society for Epidemiologic Research Student Prize Paper Review Committee (1987, 1994)
American Society for Clinical Oncology Cancer Prevention Curriculum (2006)
External Advisory Board Member, Multiple Myeloma Prevention Program Project, Washington
University (2014-2015)
Mayo Clinic SPORE in Pancreatic Cancer External Advisory Committee (2018-2023)
Connecticut Academy of Science and Engineering (CASE) Advisory Committee on Covid-19
for Reopening Connecticut (2020)
Academic and Professional Standing Committees:
Yale School of Public Health:
Doctoral (Admissions and Progress; 1991-1999)
MPH (Academic Progress; 1991-1995)
Computer (1999-2001)
Medical Studies (2000-2005)
Chair, Genetics and Public Health Interest Group (2003-2006)
Chair, C.E.A. Winslow Medal Committee (2007-2010)
Chair, Hildreth Memorial Fund Committee (2007-2012)
The Honorable Tina Brozman Foundation Small Grant Proposal Review Committee (2010)
Chair, MPH Thesis Dean’s Prize Committee (2010- )
Chair, Department of Chronic Disease Epidemiology, Epidemiology Competencies
Committee (2015- )
Committee for Academic and Professional Integrity (2018-2021)
Education Committee (2019-)
Yale School of Medicine:
Program in Investigative Medicine Doctoral Committee (1999-2007)
Mentored Clinical Research Scholar Program Advisory Board (2003-2008)
Yale Cancer Center:
Rapid Case Ascertainment System Shared Resource (1995- )
American Cancer Society Institutional Research Award Review Committee (1996-2001)
American College of Epidemiology:
Education Committee (1996-2002)
Policy Committee (1997-2003)
Peer-Reviewed Research Publications:
Accepted for Publication or In-Press
Cartmel B, Hughes M, Ercolano EA, Gottlieb L, Li F, Zhou Y, Harrigan M, Ligibel JA, von
Gruenigen VE, Gogoi R, Schwartz PE, Risch HA, Lu L, Irwin ML. Randomized trial of
exercise on depressive symptomatology and brain derived neurotrophic factor (BDNF) in
ovarian cancer survivors: The Women's Activity and Lifestyle Study in Connecticut (WALC).
App000018
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Gynecol Oncol 2021:S0090-8258(21)00195-5. doi: 10.1016/j.ygyno.2021.02.036. PMCID:
PMC Journal in Process. In Press.
Zhang H, Greenwood DC, Risch HA, Bunce D, Hardie LJ, Cade JE. Meat consumption and risk of
incident dementia: cohort study of 493,888 UK Biobank participants. Am J Clin Nutr
2021:nqab028. doi: 10.1093/ajcn/nqab028. PMCID: PMC Journal in Process. In Press.
Mocci E, Kundu P, Wheeler W, Arslan AA, Beane Freeman LE, Bracci PM, Brennan P, Canzian F,
Du M, Gallinger S, Giles GG, Goodman PJ, Kooperberg C, Le Marchand L, Neale RE, Shu
XO, Visvanathan K, White E, Zheng W, Albanes D, Andreotti G, Babic A, Bamlet WR, Berndt
SI, Blackford AL, Bueno-de-Mesquita B, Buring JE, Campa D, Chanock SJ, Childs EJ, Duell
EJ, Fuchs CS, Gaziano JM, Giovannucci EL, Goggins MG, Hartge P, Hassan MM, Holly EA,
Hoover RN, Hung RJ, Kurtz RC, Lee IM, Malats N, Milne RL, Ng K, Oberg AL, Panico S,
Peters U, Porta M, Rabe KG, Riboli E, Rothman N, Scelo G, Sesso HD, Silverman DT, Stevens
VL, Strobel O, Thompson IM, Tjonneland A, Trichopoulou A, Van Den Eeden SK, Wactawski-
Wende J, Wentzensen N, Wilkens LR, Yu H, Yuan F, Zeleniuch-Jacquotte A, Amundadottir
LT, Li D, Jacobs EJ, Petersen GM, Wolpin BM, Risch HA, Kraft P, Chatterjee N, Klein AP,
Stolzenberg-Solomon RZ. Smoking modifies pancreatic cancer risk loci on 2q21.3. Cancer
Res 2021:canres.3267.2020. doi: 10.1158/0008-5472.CAN-20-3267. PMCID: PMC Journal in
Process. In Press.
Corlin L, Ruan M, Tsilidis KK, Bouras E, Yu Y-H, Stolzenberg-Solomon R, Klein AP, Risch HA,
Amos CI, Sakoda LC, Vodi ka P, Rish PK, Beck J, Platz EA, Michaud DS. Two-Sample
Mendelian Randomization Analysis of Associations Between Periodontal Disease and Risk of
Cancer. Accepted for Publication, JNCI Cancer Spectrum. PMCID: PMC Journal in Process.
Lakeman IMM, van den Broek AJ, Vos J, Barnes DR, Adlard J, Andrulis IL, Arason A, Arnold N,
Arun BK, Balmaña J, Barrowdale D, Benitez J, Borg A, Caldés T, Caligo MA, Chung WK,
Claes KBM, GEMO Study Collaborators-, EMBRACE Collaborators, Collée JM, Couch FJ,
Daly MB, Dennis J, Dhawan M, Domchek SM, Eeles R, Engel C, Evans DG, Feliubadaló L,
Foretova L, Friedman E, Frost D, Ganz PA, Garber J, Gayther SA, Gerdes A-M, Godwin AK,
Goldgar DE, Hahnen E, Hake CR, Hamann U, Hogervorst FBL, Hooning MJ, Hopper JL,
Hulick PJ, Imyanitov EN, OCGN Investigators, HEBON Investigators, kConFab Investigators,
Isaacs C, Izatt L, Jakubowska A, James PA, Janavicius R, Jensen UB, Jiao Y, John EM, Joseph
V, Karlan BY, Kets CM, Konstantopoulou I, Kwong A, Legrand C, Leslie G, Lesueur F, Loud
JT, LubiÑski J, Manoukian S, McGuffog L, Miller A, Gomes DM, Montagna M, Mouret-
Fourme E, Nathanson KL, Neuhausen SL, Nevanlinna H, Yie JNY, Olah E, Olopade OI, Park
SK, Parsons MT, Peterlongo P, Piedmonte M, Radice P, Rantala J, Rennert G, Risch HA,
Schmutzler RK, Sharma P, Simard J, Singer CF, Stadler Z, Stoppa-Lyonnet D, Sutter C, Tan
YY, Teixeira MR, Teo SH, Teulé A, Thomassen M, Thull DL, Tischkowitz M, Toland AE,
Tung N, van Rensburg EJ, Vega A, Wappenschmidt B, Devilee P, van Asperen CJ, Bernstein
JL, Offit K, Easton DF, Rookus MA, Chenevix-Trench G, Antoniou AC, Robson M, Schmidt
MK, Consortium of Investigators of Modifiers of BRCA1 and BRCA2. The predictive ability
of the 313-variant-based polygenic risk score for contralateral breast cancer risk prediction in
women of European ancestry with a heterozygote BRCA1 or BRCA2 pathogenic variant.
Accepted for publication, Genet Med. PMCID: PMC Journal in Process.
2021
McCullough PA, Kelly RJ, Ruocco G, Lerma E, Tumlin J, Wheelan KR, Katz N, Lepor NE, Vijay
K, Carter H, Singh B, McCullough SP, Bhambi BK, Palazzuoli A, De Ferrari GM, Milligan GP,
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 21 of 633 PageID 747
Safder T, Tecson KM, Wang DD, McKinnon JE, O'Neill WW, Zervos M, Risch HA.
Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2
(COVID-19) Infection. Am J Med. 2021;134(1):16-22. doi: 10.1016/j.amjmed.2020.07.003.
PMCID: PMC7410805
Kho PF, Amant F, Annibali D, Ashton K, Attia J, Auer PL, Beckmann MW, Black A, Brinton L,
Buchanan DD, Chanock SJ, Chen C, Chen MM, Cheng THT, Cook LS, Crous-Bous M, Czene
K, De Vivo I, Dennis J, Dörk T, Dowdy SC, Dunning AM, Dürst M, Easton DF, Ekici AB,
Fasching PA, Fridley BL, Friedenreich CM, García-Closas M, Gaudet MM, Giles GG, Goode
EL, Gorman M, Haiman CA, Hall P, Hankinson SE, Hein A, Hillemanns P, Hodgson S, Hoivik
EA, Holliday EG, Hunter DJ, Jones A, Kraft P, Krakstad C, Lambrechts D, Le Marchand L,
Liang X, Lindblom A, Lissowska J, Long J, Lu L, Magliocco AM, Martin L, McEvoy M, Milne
RL, Mints M, Nassir R, Otton G, Palles C, Pooler L, Proietto T, Rebbeck TR, Renner SP, Risch
HA, Rübner M, Runnebaum I, Sacerdote C, Sarto GE, Schumacher F, Scott RJ, Setiawan VW,
Shah M, Sheng X, Shu XO, Southey MC, Tham E, Tomlinson I, Trovik J, Turman C, Tyrer JP,
Van Den Berg D, Wang Z, Wentzensen N, Xia L, Xiang YB, Yang HP, Yu H, Zheng W, Webb
PM, Thompson DJ, Spurdle AB, Glubb DM, O'Mara TA. Mendelian randomization analyses
suggest a role for cholesterol in the development of endometrial cancer. Int J Cancer
2021;148(2):307-319. doi: 10.1002/ijc.33206. PMCID: PMC7757859
Glubb DM, Thompson DJ, Aben KKH, Alsulimani A, Amant F, Annibali D, Attia J, Barricarte A,
Beckmann MW, Berchuck A, Bermisheva M, Bernardini MQ, Bischof K, Bjorge L, Bodelon C,
Brand AH, Brenton JD, Brinton LA, Bruinsma F, Buchanan DD, Burghaus S, Butzow R, Cai H,
Carney ME, Chanock SJ, Chen C, Chen XQ, Chen Z, Cook LS, Cunningham JM, De Vivo I,
deFazio A, Doherty JA, Dörk T, du Bois A, Dunning AM, Dürst M, Edwards T, Edwards RP,
Ekici AB, Ewing A, Fasching PA, Ferguson S, Flanagan JM, Fostira F, Fountzilas G,
Friedenreich CM, Gao B, Gaudet MM, Gawełko J, Gentry-Maharaj A, Giles GG, Glasspool R,
Goodman MT, Gronwald J, Harris HR, Harter P, Hein A, Heitz F, Hildebrandt MAT,
Hillemanns P, Høgdall E, Høgdall CK, Holliday EG, Huntsman DG, Huzarski T, Jakubowska
A, Jensen A, Jones ME, Karlan BY, Karnezis A, Kelley JL, Khusnutdinova E, Killeen JL, Kjaer
SK, Klapdor R, Köbel M, Konopka B, Konstantopoulou I, Kopperud RK, Koti M, Kraft P,
Kupryjanczyk J, Lambrechts D, Larson MC, Le Marchand L, Lele S, Lester J, Li AJ, Liang D,
Liebrich C, Lipworth L, Lissowska J, Lu L, Lu KH, Macciotta A, Mattiello A, May T,
McAlpine JN, McGuire V, McNeish IA, Menon U, Modugno F, Moysich KB, Nevanlinna H,
Odunsi K, Olsson H, Orsulic S, Osorio A, Palli D, Park-Simon TW, Pearce CL, Pejovic T,
Permuth JB, Podgorska A, Ramus SJ, Rebbeck TR, Riggan MJ, Risch HA, Rothstein JH,
Runnebaum IB, Scott RJ, Sellers TA, Senz J, Setiawan VW, Siddiqui N, Sieh W,
Spiewankiewicz B, Sutphen R, Swerdlow AJ, Szafron LM, Teo SH, Thompson PJ, Thomsen
LCV, Titus L, Tone A, Tumino R, Turman C, Vanderstichele A, Edwards DV, Vergote I,
Vierkant RA, Wang Z, Wang-Gohrke S, Webb PM; OPAL Study Group; AOCS Group, White
E, Whittemore AS, Winham SJ, Wu X, Wu AH, Yannoukakos D, Spurdle AB, O'Mara TA.
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Epidemiol Biomarkers Prev 2021;30(1):217-228. doi: 10.1158/1055-9965.EPI-20-0739.
PMCID: PMC Journal in Process.
Streicher SA, Klein AP, Olson SH, Kurtz RC, Amundadottir LT, DeWan AT, Zhao H, Risch HA.
A pooled genome-wide association study identifies pancreatic cancer susceptibility loci on
chromosome 19p12 and 19p13.3 in the full-Jewish population. Hum Genet 2021;140(2):309-
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Jordan SJ, Na R, Weiderpass E, Adami HO, Anderson KE, van den Brandt PA, Brinton LA, Chen
C, Cook LS, Doherty JA, Du M, Friedenreich CM, Gierach GL, Goodman MT, Krogh V, Levi
F, Lu L, Miller AB, McCann SE, Moysich KB, Negri E, Olson SH, Petruzella S, Palmer JR,
Parazzini F, Pike MC, Prizment AE, Rebbeck TR, Reynolds P, Ricceri F, Risch HA, Rohan
TE, Sacerdote C, Schouten LJ, Serraino D, Setiawan VW, Shu XO, Sponholtz TR, Spurdle AB,
Stolzenberg-Solomon RZ, Trabert B, Wentzensen N, Wilkens LR, Wise LA, Yu H, La Vecchia
C, De Vivo I, Xu W, Zeleniuch-Jacquotte A, Webb PM. Pregnancy outcomes and risk of
endometrial cancer: A pooled analysis of individual participant data in the Epidemiology of
Endometrial Cancer Consortium. Int J Cancer 2021;148(9):2068-2078. doi: 10.1002/ijc.33360.
PMCID: PMC7969437
Lee AW, Rosenzweig S, Wiensch A; Australian Ovarian Cancer Study Group, Ramus SJ, Menon
U, Gentry-Maharaj A, Ziogas A, Anton-Culver H, Whittemore AS, Sieh W, Rothstein JH,
McGuire V, Wentzensen N, Bandera EV, Qin B, Terry KL, Cramer DW, Titus L, Schildkraut
JM, Berchuck A, Goode EL, Kjaer SK, Jensen A, Jordan SJ, Ness RB, Modugno F, Moysich K,
Thompson PJ, Goodman MT, Carney ME, Chang-Claude J, Rossing MA, Harris HR, Doherty
JA, Risch HA, Khoja L, Alimujiang A, Phung MT, Brieger K, Mukherjee B, Pharoah PDP, Wu
AH, Pike MC, Webb PM, Pearce CL. Expanding Our Understanding of Ovarian Cancer Risk:
The Role of Incomplete Pregnancies. J Natl Cancer Inst 2021;113(3):301-308. doi:
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Dighe SG, Chen J, Yan L, He Q, Gharahkhani P, Onstad L, Levine DM, Palles C, Ye W, Gammon
MD, Iyer PG, Anderson LA, Liu G, Wu AH, Dai JY, Chow WH, Risch HA, Lagergren J,
Shaheen NJ, Bernstein L, Corley DA, Prenen H, deCaestecker J, MacDonald D, Moayyedi P,
Barr H, Love SB, Chegwidden L, Attwood S, Watson P, Harrison R, Ott K, Moebus S,
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Vashist Y, Nöthen MM, Izbicki JR, Manner H, Neuhaus H, Rösch T, Böhmer AC, Hölscher
AH, Anders M, Pech O, Schumacher B, Schmidt C, Schmidt T, Noder T, Lorenz D, Vieth M,
May A, Hess T, Kreuser N, Becker J, Ell C, Ambrosone CB, Moysich KB, MacGregor S,
Tomlinson I, Whiteman DC, Jankowski J, Schumacher J, Vaughan TL, Madeleine MM, Hardie
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PanGenEU Investigators, García-Closas M, Kogevinas M, Rothman N, Silverman DT;
SBC/EPICURO Investigators, Albanes D, Arslan AA, Beane-Freeman L, Bracci PM, Brennan
P, Bueno-de-Mesquita B, Buring J, Canzian F, Du M, Gallinger S, Gaziano JM, Goodman PJ,
Gunter M, LeMarchand L, Li D, Neale RE, Peters U, Petersen GM, Risch HA, Sánchez MJ,
Shu XO, Thornquist MD, Visvanathan K, Zheng W, Chanock SJ, Easton D, Wolpin BM,
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McCullough PA, Alexander PE, Armstrong R, Arvinte C, Bain AF, Bartlett RP, Berkowitz RL,
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RA, Fareed GC, Farella A, Fonseca SNS, Geyer CE Jr, Gonnering RS, Graves KE, Gross KBV,
Hazan S, Held KS, Hight HT, Immanuel S, Jacobs MM, Ladapo JA, Lee LH, Littell J, Lozano
I, Mangat HS, Marble B, McKinnon JE, Merritt LD, Orient JM, Oskoui R, Pompan DC, Procter
BC, Prodromos C, Rajter JC, Rajter JJ, Ram CVS, Rios SS, Risch HA, Robb MJA, Rutherford
M, Scholz M, Singleton MM, Tumlin JA, Tyson BM, Urso RG, Victory K, Vliet EL, Wax CM,
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2020;189(11):1218-1226. doi: 10.1093/aje/kwaa093. PMCID: PMC7546206
Zhang H, Ahearn TU, Lecarpentier J, Barnes D, Beesley J, Qi G, Jiang X, O'Mara TA, Zhao N,
Bolla MK, Dunning AM, Dennis J, Wang Q, Ful ZA, Aittomäki K, Andrulis IL, Anton-Culver
H, Arndt V, Aronson KJ, Arun BK, Auer PL, Azzollini J, Barrowdale D, Becher H, Beckmann
MW, Behrens S, Benitez J, Bermisheva M, Bialkowska K, Blanco A, Blomqvist C, Bogdanova
NV, Bojesen SE, Bonanni B, Bondavalli D, Borg A, Brauch H, Brenner H, Briceno I, Broeks
A, Brucker SY, Brüning T, Burwinkel B, Buys SS, Byers H, Caldés T, Caligo MA, Calvello M,
Campa D, Castelao JE, Chang-Claude J, Chanock SJ, Christiaens M, Christiansen H, Chung
WK, Claes KBM, Clarke CL, Cornelissen S, Couch FJ, Cox A, Cross SS, Czene K, Daly MB,
Devilee P, Diez O, Domchek SM, Dörk T, Dwek M, Eccles DM, Ekici AB, Evans DG,
Fasching PA, Figueroa J, Foretova L, Fostira F, Friedman E, Frost D, Gago-Dominguez M,
Gapstur SM, Garber J, García-Sáenz JA, Gaudet MM, Gayther SA, Giles GG, Godwin AK,
Goldberg MS, Goldgar DE, González-Neira A, Greene MH, Gronwald J, Guénel P, Häberle L,
Hahnen E, Haiman CA, Hake CR, Hall P, Hamann U, Harkness EF, Heemskerk-Gerritsen
BAM, Hillemanns P, Hogervorst FBL, Holleczek B, Hollestelle A, Hooning MJ, Hoover RN,
Hopper JL, Howell A, Huebner H, Hulick PJ, Imyanitov EN; kConFab Investigators; ABCTB
Investigators, Isaacs C, Izatt L, Jager A, Jakimovska M, Jakubowska A, James P, Janavicius R,
Janni W, John EM, Jones ME, Jung A, Kaaks R, Kapoor PM, Karlan BY, Keeman R, Khan S,
Khusnutdinova E, Kitahara CM, Ko YD, Konstantopoulou I, Koppert LB, Koutros S,
Kristensen VN, Laenkholm AV, Lambrechts D, Larsson SC, Laurent-Puig P, Lazaro C,
Lazarova E, Lejbkowicz F, Leslie G, Lesueur F, Lindblom A, Lissowska J, Lo WY, Loud JT,
Lubinski J, Lukomska A, MacInnis RJ, Mannermaa A, Manoochehri M, Manoukian S,
Margolin S, Martinez ME, Matricardi L, McGuffog L, McLean C, Mebirouk N, Meindl A,
Menon U, Miller A, Mingazheva E, Montagna M, Mulligan AM, Mulot C, Muranen TA,
Nathanson KL, Neuhausen SL, Nevanlinna H, Neven P, Newman WG, Nielsen FC, Nikitina-
Zake L, Nodora J, Offit K, Olah E, Olopade OI, Olsson H, Orr N, Papi L, Papp J, Park-Simon
TW, Parsons MT, Peissel B, Peixoto A, Peshkin B, Peterlongo P, Peto J, Phillips KA,
Piedmonte M, Plaseska-Karanfilska D, Prajzendanc K, Prentice R, Prokofyeva D, Rack B,
Radice P, Ramus SJ, Rantala J, Rashid MU, Rennert G, Rennert HS, Risch HA, Romero A,
Rookus MA, Rübner M, Rüdiger T, Saloustros E, Sampson S, Sandler DP, Sawyer EJ,
Scheuner MT, Schmutzler RK, Schneeweiss A, Schoemaker MJ, Schöttker B, Schürmann P,
Senter L, Sharma P, Sherman ME, Shu XO, Singer CF, Smichkoska S, Soucy P, Southey MC,
Spinelli JJ, Stone J, Stoppa-Lyonnet D; EMBRACE Study; GEMO Study Collaborators,
Swerdlow AJ, Szabo CI, Tamimi RM, Tapper WJ, Taylor JA, Teixeira MR, Terry M,
Thomassen M, Thull DL, Tischkowitz M, Toland AE, Tollenaar RAEM, Tomlinson I, Torres
D, Troester MA, Truong T, Tung N, Untch M, Vachon CM, van den Ouweland AMW, van der
Kolk LE, van Veen EM, vanRensburg EJ, Vega A, Wappenschmidt B, Weinberg CR, Weitzel
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JN, Wildiers H, Winqvist R, Wolk A, Yang XR, Yannoukakos D, Zheng W, Zorn KK, Milne
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Nat Genet 2020;52(6):572-581. doi: 10.1038/s41588-020-0609-2. PMCID: PMC7808397
Babic A, Sasamoto N, Rosner BA, Tworoger SS, Jordan SJ, Risch HA, Harris HR, Rossing MA,
Doherty JA, Fortner RT, Chang-Claude J, Goodman MT, Thompson PJ, Moysich KB, Ness
RB, Kjaer SK, Jensen A, Schildkraut JM, Titus LJ, Cramer DW, Bandera EV, Qin B, Sieh W,
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2020;6(6):e200421. doi: 10.1001/jamaoncol.2020.0421. PMCID: PMC7118668
Fachal L, Aschard H, Beesley J, Barnes DR, Allen J, Kar S, Pooley KA, Dennis J, Michailidou K,
Turman C, Soucy P, Lemaçon A, Lush M, Tyrer JP, Ghoussaini M, Moradi Marjaneh M, Jiang
X, Agata S, Aittomäki K, Alonso MR, Andrulis IL, Anton-Culver H, Antonenkova NN, Arason
A, Arndt V, Aronson KJ, Arun BK, Auber B, Auer PL, Azzollini J, Balmaña J, Barkardottir
RB, Barrowdale D, Beeghly-Fadiel A, Benitez J, Bermisheva M, Białkowska K, Blanco AM,
Blomqvist C, Blot W, Bogdanova NV, Bojesen SE, Bolla MK, Bonanni B, Borg A, Bosse K,
Brauch H, Brenner H, Briceno I, Brock IW, Brooks-Wilson A, Brüning T, Burwinkel B, Buys
SS, Cai Q, Caldés T, Caligo MA, Camp NJ, Campbell I, Canzian F, Carroll JS, Carter BD,
Castelao JE, Chiquette J, Christiansen H, Chung WK, Claes KBM, Clarke CL; GEMO Study
Collaborators; EMBRACE Collaborators, Collée JM, Cornelissen S, Couch FJ, Cox A, Cross
SS, Cybulski C, Czene K, Daly MB, de la Hoya M, Devilee P, Diez O, Ding YC, Dite GS,
Domchek SM, Dörk T, Dos-Santos-Silva I, Droit A, Dubois S, Dumont M, Duran M, Durcan L,
Dwek M, Eccles DM, Engel C, Eriksson M, Evans DG, Fasching PA, Fletcher O, Floris G,
Flyger H, Foretova L, Foulkes WD, Friedman E, Fritschi L, Frost D, Gabrielson M, Gago-
Dominguez M, Gambino G, Ganz PA, Gapstur SM, Garber J, García-Sáenz JA, Gaudet MM,
Georgoulias V, Giles GG, Glendon G, Godwin AK, Goldberg MS, Goldgar DE, González-
Neira A, Tibiletti MG, Greene MH, Grip M, Gronwald J, Grundy A, Guénel P, Hahnen E,
Haiman CA, Håkansson N, Hall P, Hamann U, Harrington PA, Hartikainen JM, Hartman M, He
W, Healey CS, Heemskerk-Gerritsen BAM, Heyworth J, Hillemanns P, Hogervorst FBL,
Hollestelle A, Hooning MJ, Hopper JL, Howell A, Huang G, Hulick PJ, Imyanitov EN;
KConFab Investigators; HEBON Investigators; ABCTB Investigators, Isaacs C, Iwasaki M,
Jager A, Jakimovska M, Jakubowska A, James PA, Janavicius R, Jankowitz RC, John EM,
Johnson N, Jones ME, Jukkola-Vuorinen A, Jung A, Kaaks R, Kang D, Kapoor PM, Karlan
BY, Keeman R, Kerin MJ, Khusnutdinova E, Kiiski JI, Kirk J, Kitahara CM, Ko YD,
Konstantopoulou I, Kosma VM, Koutros S, Kubelka-Sabit K, Kwong A, Kyriacou K, Laitman
Y, Lambrechts D, Lee E, Leslie G, Lester J, Lesueur F, Lindblom A, Lo WY, Long J,
Lophatananon A, Loud JT, LubiÑski J, MacInnis RJ, Maishman T, Makalic E, Mannermaa A,
Manoochehri M, Manoukian S, Margolin S, Martinez ME, Matsuo K, Maurer T, Mavroudis D,
Mayes R, McGuffog L, McLean C, Mebirouk N, Meindl A, Miller A, Miller N, Montagna M,
Moreno F, Muir K, Mulligan AM, Muñoz-Garzon VM, Muranen TA, Narod SA, Nassir R,
Nathanson KL, Neuhausen SL, Nevanlinna H, Neven P, Nielsen FC, Nikitina-Zake L, Norman
A, Offit K, Olah E, Olopade OI, Olsson H, Orr N, Osorio A, Pankratz VS, Papp J, Park SK,
Park-Simon TW, Parsons MT, Paul J, Pedersen IS, Peissel B, Peshkin B, Peterlongo P, Peto J,
Plaseska-Karanfilska D, Prajzendanc K, Prentice R, Presneau N, Prokofyeva D, Pujana MA,
Pylkäs K, Radice P, Ramus SJ, Rantala J, Rau-Murthy R, Rennert G, Risch HA, Robson M,
Romero A, Rossing M, Saloustros E, Sánchez-Herrero E, Sandler DP, Santamariña M,
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Saunders C, Sawyer EJ, Scheuner MT, Schmidt DF, Schmutzler RK, Schneeweiss A,
Schoemaker MJ, Schöttker B, Schürmann P, Scott C, Scott RJ, Senter L, Seynaeve CM, Shah
M, Sharma P, Shen CY, Shu XO, Singer CF, Slavin TP, Smichkoska S, Southey MC, Spinelli
JJ, Spurdle AB, Stone J, Stoppa-Lyonnet D, Sutter C, Swerdlow AJ, Tamimi RM, Tan YY,
Tapper WJ, Taylor JA, Teixeira MR, Tengström M, Teo SH, Terry MB, Teulé A, Thomassen
M, Thull DL, Tischkowitz M, Toland AE, Tollenaar RAEM, Tomlinson I, Torres D, Torres-
Mejía G, Troester MA, Truong T, Tung N, Tzardi M, Ulmer HU, Vachon CM, van Asperen CJ,
van der Kolk LE, van Rensburg EJ, Vega A, Viel A, Vijai J, Vogel MJ, Wang Q,
Wappenschmidt B, Weinberg CR, Weitzel JN, Wendt C, Wildiers H, Winqvist R, Wolk A, Wu
AH, Yannoukakos D, Zhang Y, Zheng W, Hunter D, Pharoah PDP, Chang-Claude J, García-
Closas M, Schmidt MK, Milne RL, Kristensen VN, French JD, Edwards SL, Antoniou AC,
Chenevix-Trench G, Simard J, Easton DF, Kraft P, Dunning AM. Fine-mapping of 150 breast
cancer risk regions identifies 191 likely target genes. Nat Genet 2020;52(1):56-73. doi:
10.1038/s41588-019-0537-1. PMCID: PMC6974400
Feng H, Gusev A, Pasaniuc B, Wu L, Long J, Abu-Full Z, Aittomäki K, Andrulis IL, Anton-Culver
H, Antoniou AC, Arason A, Arndt V, Aronson KJ, Arun BK, Asseryanis E, Auer PL, Azzollini
J, Balmaña J, Barkardottir RB, Barnes DR, Barrowdale D, Beckmann MW, Behrens S, Benitez
J, Bermisheva M, Białkowska K, Blanco A, Blomqvist C, Boeckx B, Bogdanova NV, Bojesen
SE, Bolla MK, Bonanni B, Borg A, Brauch H, Brenner H, Briceno I, Broeks A, Brüning T,
Burwinkel B, Cai Q, Caldés T, Caligo MA, Campbell I, Canisius S, Campa D, Carter BD,
Carter J, Castelao JE, Chang-Claude J, Chanock SJ, Christiansen H, Chung WK, Claes KBM,
Clarke CL; GEMO Study Collaborators; EMBRACE Collaborators; GC-HBOC study
Collaborators, Couch FJ, Cox A, Cross SS, Cybulski C, Czene K, Daly MB, de la Hoya M, De
Leeneer K, Dennis J, Devilee P, Diez O, Domchek SM, Dörk T, Dos-Santos-Silva I, Dunning
AM, Dwek M, Eccles DM, Ejlertsen B, Ellberg C, Engel C, Eriksson M, Fasching PA, Fletcher
O, Flyger H, Fostira F, Friedman E, Fritschi L, Frost D, Gabrielson M, Ganz PA, Gapstur SM,
Garber J, García-Closas M, García-Sáenz JA, Gaudet MM, Giles GG, Glendon G, Godwin AK,
Goldberg MS, Goldgar DE, González-Neira A, Greene MH, Gronwald J, Guénel P, Haiman
CA, Hall P, Hamann U, Hake C, He W, Heyworth J, Hogervorst FBL, Hollestelle A, Hooning
MJ, Hoover RN, Hopper JL, Huang G, Hulick PJ, Humphreys K, Imyanitov EN; ABCTB
Investigators; HEBON Investigators; BCFR Investigators; OCGN Investigators, Isaacs C,
Jakimovska M, Jakubowska A, James P, Janavicius R, Jankowitz RC, John EM, Johnson N,
Joseph V, Jung A, Karlan BY, Khusnutdinova E, Kiiski JI, Konstantopoulou I, Kristensen VN,
Laitman Y, Lambrechts D, Lazaro C, Leroux D, Leslie G, Lester J, Lesueur F, Lindor N,
Lindström S, Lo WY, Loud JT, LubiÑski J, Makalic E, Mannermaa A, Manoochehri M,
Manoukian S, Margolin S, Martens JWM, Martinez ME, Matricardi L, Maurer T, Mavroudis D,
McGuffog L, Meindl A, Menon U, Michailidou K, Kapoor PM, Miller A, Montagna M,
Moreno F, Moserle L, Mulligan AM, Muranen TA, Nathanson KL, Neuhausen SL, Nevanlinna
H, Nevelsteen I, Nielsen FC, Nikitina-Zake L, Offit K, Olah E, Olopade OI, Olsson H, Osorio
A, Papp J, Park-Simon TW, Parsons MT, Pedersen IS, Peixoto A, Peterlongo P, Peto J, Pharoah
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MJ, Bloom G, Bogdanova N, Brinton LA, Brooks-Wilson A, Brown R, Butzow R, Cai Q,
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ND, Leminen A, Levine DA, Liang D, Lim BK, Lin J, Lissowska J, Lu KH, LubiÑski J, Lurie
G, Massuger LF, Matsuo K, McGuire V, McLaughlin JR, Menon U, Modugno F, Moysich KB,
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RA, Wentzensen N, Lancaster JM, Cheng JQ, Berchuck A, Pharoah PDP, Schildkraut JM,
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Fenstermacher D, Fridley BL, Garcia-Closas M, Gayther SA, Ge W, Gentry-Maharaj A,
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Monteiro ANA, Narod SA, Pharoah PDP, Phelan CM, Qu X, Ramus SJ, Risch H, Schildkraut
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Lu L, Zhang C, Zhu G, Irwin M, Risch H, Menato G, Mitidieri M, Katsaros D, Yu H. Telomerase
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MJ, Bogdanova N, Bolton KL, Brewster W, Brooks-Wilson A, Brown R, Butzow R, Caldes T,
Caligo MA, Campbell I, Chang-Claude J, Chen YA, Cook LS, Couch FJ, Cramer DW,
Cunningham JM, Despierre E, Doherty JA, Dörk T, Dürst M, Eccles DM, Ekici AB, Easton D
for the EMBRACE Investigators, Fasching PA, de Fazio A, Fenstermacher DA, Flanagan JM,
Fridley BL, Friedman E, Gao B, Sinilnikova O for the GEMO Study Collaborators, Gentry-
Maharaj A, Godwin AK, Goode EL, Goodman MT, Gross J, Hansen TVO, Harnett P, Rookus
M for the HEBON Investigators, Heikkinen T, Hein R, Høgdall C, Høgdall E, Iversen ES,
Jakubowska A, Johnatty SE, Karlan BY, Kauff ND, Kaye SB, Chenevix-Trench G for the
kConFab Investigators and the Consortium of Investigators of Modifiers of BRCA1/2,
Kelemen LE, Kiemeney LA, Krüger Kjaer S, Lambrechts D, LaPolla JP, Lázaro C, Le ND,
Leminen A, Leunen K, Levine DA, Lu Y, Lundvall L, Macgregor S, Marees T, Massuger LF,
McLaughlin JR, Menon U, Montagna M, Moysich KB, Narod SA, Nathanson KL, Nedergaard
L, Ness RB, Nevanlinna H, Nickels S, Osorio A, Paul J, Pearce CL, Phelan CM, Pike MC,
Radice P, Rossing MA, Schildkraut JM, Sellers TA, Singer CF, Song H, Stram DO, Sutphen
R, Lindblom A for the SWE-BRCA Investigators, Terry KL, Tsai Y-Y, van Altena AM,
Vergote I, Vierkant RA, Vitonis AF, Walsh C, Wang-Gohrke S, Wappenschmidt B, Wu AH,
Ziogas A, Berchuck A and Risch HA for the Ovarian Cancer Association Consortium. The
role of KRAS rs61764370 in invasive epithelial ovarian cancer: implications for clinical
testing. Clin Cancer Res 2011;17:3742-50. PMCID: PMC3107901.
Zeng H, Yu H, Lu L, Jain D, Kidd MS, Saif MW, Chanock SJ and Hartge P for the PanScan
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survival in pancreatic cancer. Pancreas 2011;40:657-63. PMCID: PMC3116071.
Navarro Silvera SA, Mayne ST, Risch HA, Gammon MD, Vaughan T, Chow W-H, Dubin JA,
Dubrow R, Schoenberg J, Stanford JL, West AB, Rotterdam H, Blot WJ. Principal component
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Lochhead P, Frank B, Hold GL, Rabkin CS, Ng MTH, Vaughan TL, Risch HA, Gammon MD,
Lissowska J, Weck MN, Raum E, Müller H, Illig T, Klopp N, Dawson A, McColl KE,
Brenner H, Chow WH, El-Omar EM. Genetic variation in the prostate stem cell antigen gene
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Lochhead P, Ng MT, Hold GL, Rabkin CS, Vaughan TL, Gammon MD, Risch HA, Lissowska J,
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Zhou Y, Irwin ML, Risch HA.
Pre- and post-diagnosis body mass index, weight change and
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Bertuccio P, La Vecchia C, Silverman D, Petersen G, Bracci PM, Negri E, Li D, Risch HA, Olson
SH, Gallinger S, Miller AB, Bueno-de-Mesquita HB, Talamini R, Polesel J, Ghadirian P,
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Arem H, Irwin ML, Zhou Y, Lu L, Risch H, Yu H. Physical activity and endometrial cancer in a
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Soskolne CL, Jhangri GS, Scott HM, Brenner DR, Siemiatycki J, Lakhani R, Gérin M, Dewar R,
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acids and the risk of lung cancer: Evidence for specificity of association. Int J Occup Environ
Health 2011;17:1-8. *Not a result of NIH funding.
2010
Goode EL, Chenevix-Trench G, Song H, Ramus SJ, Notaridou M, Lawrenson K, Widschwendter
M, Vierkant RA, Larson MC, Kjaer SK, Birrer MJ, Berchuck A, Schildkraut J, Tomlinson I,
Kiemeney LA, Cook LS, Gronwald J, Garcia-Closas M, Gore ME, Campbell I, Whittemore
AS, Sutphen R, Phelan C, Anton- Culver H, Pearce CL, Lambrechts D, Rossing MA, Chang-
Claude J, Moysich KB, Goodman MT, Dörk T, Nevanlinna H, Ness RB, Rafnar T, Hogdall C,
Hogdall E, Fridley BL, Cunningham JM, Sieh W, McGuire V, Godwin AK, Cramer DW,
Hernandez D, Levine D, Lu K, Iversen ES, Palmieri RT, Houlston R, van Altena AM, Aben
KKH, Massuger LFAG, Brooks-Wilson A, Kelemen LE, Le ND, Jakubowska A, Lubinski J,
Medrek K, Stafford A, Easton DF, Tyrer J, Bolton KL, Harrington P, Eccles D, Chen A,
Molina AN, Davila BN, Arango H, Tsai Y-Y, Chen Z, Risch HA, McLaughlin J, Narod SA,
Ziogas A, Brewster W, Gentry-Maharaj A, Menon U, Wu AH, Stram DO, Pike MC, The
Wellcome Trust Case-Control Consortium, Beesley J, Webb PM, The Australian Cancer Study
(Ovarian Cancer), The Australian Ovarian Cancer Study Group, Chen X, Ekici AB, Thiel FC,
Beckmann MW, Yang H, Wentzensen N, Lissowska J, Fasching PA, Despierre E, Amant F,
Vergote I, Doherty J, Hein R, Wang-Gohrke S, Lurie G, Carney ME, Thompson PJ,
Runnebaum I, Hillemanns P, Dürst M, Antonenkova N, Bogdanova N, Leminen A, Butzow R,
Heikkinen T, Stefansson K, Sulem P, Besenbacher S, Sellers TA, Gayther SA, Pharoah PDP,
The Ovarian Cancer Association Consortium (OCAC). A genome-wide association study
identifies susceptibility loci for ovarian cancer at 2q31 and 8q24. Nat Genet 2010;42:874-9.
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Ratner E, Lu L, Boeke M, Barnett R, Nallur S, Chin LJ, Pelletier C, Blitzblau R, Tassi R,
Paranjape T, Hui P, Godwin AK, Yu H, Risch H, Rutherford T, Schwartz P, Santin A, Matloff
E, Zelterman D, Slack FJ, Weidhaas JB. A KRAS-variant in ovarian cancer acts as a genetic
marker of cancer risk. Cancer Res 2010;70:6509-15. PMCID: PMC2923587.
Cook MB, Kamangar F, Whiteman DC, Freedman ND, Gammon MD, Bernstein L, Brown LM,
Risch HA, Ye W, Sharp L, Wu AH, Ward MH, Giffen C, Casson AG, Abnet CC, Murray LJ,
Corley DA, Nyrén O, Vaughan TL, Chow W-H. Cigarette smoking and adenocarcinomas of
the esophagus and esophagogastric junction: a pooled analysis from the International
BEACON Consortium. J Natl Cancer Inst 2010;102:1344-53. PMCID: PMC2935475.
Risch HA, Yu H, Lu L, Kidd MS. ABO blood group, Helicobacter pylori seropositivity, and risk
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Moysich KB, Chang-Claude J, Wang-Gohrke S, Cramer DW, Terry KL, Hankinson SE,
Tworoger SS, Garcia-Closas M, Yang H, Lissowska J, Chanock SJ, Pharoah PD, Song H,
Whitemore AS, Pearce CL, Stram DO, Wu AH, Pike MC, Gayther SA, Ramus SJ, Menon U,
Gentry-Maharaj A, Anton-Culver H, Ziogas A, Hogdall E, Kjaer SK, Hogdall C, Berchuck A,
Schildkraut JM, Iversen ES, Moorman PG, Phelan CM, Sellers TA, Cunningham JM, Vierkant
RA, Rider DN, Goode EL, Haviv I, Chenevix-Trench G; Ovarian Cancer Association
Consortium; Australian Ovarian Cancer Study Group; Australian Cancer Study (Ovarian
Cancer). Evaluation of candidate stromal epithelial cross-talk genes identifies association
between risk of serous ovarian cancer and TERT, a cancer susceptibility "hot-spot". PLoS
Genet 2010;6:e1001016. PMCID: PMC2900295.
Elliott KS, Zeggini E, McCarthy MI, Gudmundsson J, Sulem P, Stacey SN, Thorlacius S,
Amundadottir L, Grönberg H, Xu J, Gaborieau V, Eeles RA, Neal DE, Donovan JL, Hamdy
FC, Muir K, Hwang SJ, Spitz MR, Zanke B, Carvajal-Carmona L, Brown KM; Australian
Melanoma Family Study Investigators, Hayward NK, Macgregor S, Tomlinson IP, Lemire M,
Amos CI, Murabito JM, Isaacs WB, Easton DF, Brennan P, PanScan Consortium, Barkardottir
RB, Gudbjartsson DF, Rafnar T, Hunter DJ, Chanock SJ, Stefansson K, Ioannidis JP.
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Petersen GM, Amundadottir L, Fuchs CS, Kraft P, Stolzenberg-Solomon RZ, Jacobs KB, Arslan
AA, Bueno-de-Mesquita HB, Gallinger S, Gross M, Helzlsouer K, Holly EA, Jacobs EJ, Klein
AP, LaCroix A, Li D, Mandelson MT, Olson SH, Risch HA, Zheng W, Albanes D, Bamlet
WR, Berg CD, Boutron-Ruault M-C, Buring JE, Bracci PM, Canzian F, Clipp S, Cotterchio
M, de Andrade M, Duell EJ, Gaziano JM, Giovannucci EL, Goggins M, Hallmans G,
Hankinson SE, Hassan M, Howard B, Hunter DJ, Hutchinson A, Jenab M, Kaaks R,
Kooperberg C, Krogh V, Kurtz RC, Lynch SM, McWilliams RR, Mendelsohn JB, Michaud
DS, Parikh H, Patel AV, Peeters PHM, Rajkovic A, Riboli E, Rodriguez L, Seminara D, Shu
X-O, Thomas G, Tjønneland A, Tobias GS, Trichopoulos D, Van Den Eeden SK, Virtamo J,
Wactawski-Wende J, Wang Z, Wolpin B, Yu H, Yu K, Zeleniuch-Jacquotte A, Fraumeni JF
Jr, Hoover RN, Hartge P, Chanock SJ. A genome-wide association study identifies pancreatic
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2009
Song H, Ramus SJ, Tyrer J, Bolton K, Gentry-Maharaj A, Wozniak E, Anton-Culver H, Chang-
Claude J, Cramer DW, DiCioccio R, Dörk T, Goode EL, Goodman MT, Schildkraut JM,
Sellers T, Beckmann MW, Beesley J, Blaakaer J, Carney ME, Chanock S, Chen Z,
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Gore ME, Hankinson SE, Hogdall C, Hogdall E, Iversen ES, Jacobs IJ, Jakubowska A,
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Moysich K, Narod S, Phelan C, Risch H, Stram DO, Strick R, Terry KL, Tsai Y-Y, Tworoger
SS, Van Den Berg DJ, Vierkant RA, Wang-Gohrke S, Webb PM, Wilkens LR, Wu AH, Yang
H, Ziogas A, Australian Cancer (Ovarian) Study, The Australian Ovarian Cancer Study Group,
The Hannover-Jena Ovarian Cancer Study Group, The Ovarian Cancer Association
Consortium, Whittemore AS, Rossing MA, Ponder BAJ, Pearce CL, Ness RB, Menon U,
Krüger Kjær S, Gronwald J, Garcia-Closas M, Fasching P, Easton DF, Chenevix-Trench G,
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Amundadottir L, Kraft P, Stolzenberg-Solomon RZ, Fuchs CS, Petersen GM, Arslan AA, Bueno-
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W, Berg CD, Berrino F, Bingham S, Buring JE, Bracci PM, Canzian F, Clavel-Chapelon F,
Clipp S, Cotterchio M, de Andrade M, Duell EJ, Fox JW Jr, Gallinger S, Gaziano JM,
Giovannucci E, Goggins M, González C, Hallmans G, Hankinson SE, Hassan M, Holly EA,
Hunter DJ, Hutchinson A, Jackson R, Jacobs K, Jenab M, Kaaks R, Klein AP, Kooperberg C,
Kurtz RC, Li D, Lynch SM, Mandelson M, McWilliams RR, Mendelsohn JB, Michaud DS,
Olson SH, Overvad K, Patel AV, Peeters PHM, Rajkovic A, Riboli E, Risch HA, Shu X-O,
Thomas G, Tobias GS, Trichopoulos D, Van Den Eeden SK, Virtamo J, Wactawski-Wende J,
Wolpin BM, Yu H, Yu K, Zeleniuch-Jacquotte A, Chanock SJ, Hartge P, Hoover RN.
Genome-wide association study identifies ABO blood group susceptibility variants for
pancreatic cancer. Nat Genet 2009;41:986-90. PMCID: PMC2839871.
Hoyo C, Schildkraut JM, Murphy SK, Chow W-H, Vaughan TL, Risch H, Marks JR, Jirtle RL,
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esophageal and gastric adenocarcinoma. Int J Cancer 2009;125:2673-8.
PMCID:
PMC3008656.
Concato J, Jain D, Uchio E, Risch H, Li WW, Wells CK. Molecular markers and death from
prostate cancer. Ann Intern Med 2009;150:595-603. *Not a result of NIH funding.
Bentov Y, Brown TJ, Akbari MR, Royer R, Risch H, Rosen B, McLaughlin J, Sun P, Zhang S,
Narod SA, Casper RF. Polymorphic variation of genes in the fibrinolytic system and the risk
of ovarian cancer. PLoS ONE 2009;4:e5918. PMCID: PMC2691597.
Figueroa JD, Terry MB, Gammon MD, Vaughan TL, Risch HA, Zhang F-F, Kleiner DE, Bennett
WP, Howe CL, Dubrow R, Mayne ST, Fraumeni JF Jr, Chow W-H. Cigarette smoking, body
mass index, gastro-esophageal reflux disease, and non-steroidal anti-inflammatory drug use
and risk of subtypes of esophageal and gastric cancers by P53 overexpression. Cancer Causes
Control 2009;20:361-8. PMCID: PMC2726999.
Hold GL, Rabkin CS, Gammon MD, Berry SH, Smith MG, Lissowska J, Risch HA, Chow W-H,
Mowat NAG, Vaughan TL, El-Omar EM. CD14-159C/T and TLR9-1237T/C polymorphisms
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Metcalfe KA, Fan I, McLaughlin J, Risch HA, Rosen B, Murphy J, Bradley L, Armel S, Sun P,
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2008
Antoniou AC, Cunningham AP, Peto J, Evans DG, Lalloo F, Narod SA, Risch HA, Eyfjord JE,
Hopper JL, Southey MC, Olsson H, Johannsson O, Borg A, Pasini B, Radice P, Manoukian S,
Eccles DM, Tang N, Olah E, Anton-Culver H, Warner E, Lubinski J, Gronwald J, Gorski B,
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Easton DF. The BOADICEA model of genetic susceptibility to breast and ovarian cancers:
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Pearce CL, Wu AH, Gayther SA, Bale AE, Australian Cancer Study (Ovarian Cancer) and
Australian Ovarian Cancer Study Group, Beck PA, Beesley J, Chanock S, Cramer DW,
DiCioccio R, Edwards R, Fredericksen ZS, Garcia-Closas M, Goode EL, Green AC, Hartmann
LC, Hogdall E, Kruger Kjaer S, Lissowska J, McGuire V, Modugno F, Moysich K, Ness RB,
Ramus SJ, Risch HA, Sellers TA, Song H, Stram DO, Terry KL, Webb PM, Whiteman DC,
Whittemore AS, Zheng W, Pharoah PDP, Chenevix-Trench G, Pike MC, Schildkraut J,
Berchuck A, on behalf of the Ovarian Cancer Association Consortium (OCAC). Progesterone
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Collaborative Group on Epidemiological Studies of Ovarian Cancer. Beral V, Doll R, Hermon C,
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from 45 epidemiological studies including 23257 women with ovarian cancer and 87303
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Harley I, Rosen B, Risch HA, Siminovitch K, Beiner ME, McLaughlin J, Sun P, Narod SA.
Ovarian cancer risk is associated with a common variant in the promoter sequence of the
mismatch repair gene MLH1. Gynecol Oncol 2008;109:384-7. PMCID: PMC3060029.
2007
Terry MB, Gammon MD, Zhang FF, Vaughan TL, Chow W-H, Risch HA, Schoenberg JB,
Mayne ST, Stanford JL, West AB, Rotterdam H, Blot WJ, Fraumeni JF Jr, Santella RM.
Alcohol dehydrogenase 3 and risk of esophageal and gastric adenocarcinomas. Cancer Causes
Control 2007;18:1039-46.
Concato J, Jain D, Li WW, Risch HA, Uchio EM, Wells CK. Molecular markers and mortality in
prostate cancer. BJU Intl 2007;100:1259-63.
Hold GL, Rabkin CS, Chow W-H, Smith MG, Gammon MD, Risch HA, Vaughan TL, McColl
KEL, Lissowska J, Zatonski W, Schoenberg JB, Blot WJ, Mowat NAG, Fraumeni JF Jr, El-
Omar EM. A functional polymorphism of Toll-like receptor 4 gene increases risk of gastric
carcinoma and its precursors. Gastroenterology 2007;132:905-12.
Wideroff L, Vaughan TL, Farin FM, Gammon MD, Risch H, Stanford JL, Chow W-H. GST,
NAT1, CYP1A1 polymorphisms and risk of esophageal and gastric adenocarcinomas. Cancer
Detect Prev 2007;31:233-6.
Brokaw J, Katsaros D, Wiley A, Lu L, Su D, Sochirca O, de la Longrais IAR, Mayne S, Risch H,
Yu H. IGF-I in epithelial ovarian cancer and its role in disease progression. Growth Factors
2007;25:346-54.
McLaughlin JR, Risch HA, Lubinski J, Moller P, Ghadirian P, Lynch H, Karlan B, Fishman D,
Rosen B, Neuhausen SL, Offit K, Kauff N, Domchek S, Tung N, Friedman E, Foulkes W, Sun
P, Narod SA, Hereditary Ovarian Cancer Clinical Study Group. Reproductive risk factors for
ovarian cancer in carriers of BRCA1 or BRCA2 mutations: a case-control study. Lancet
Oncol 2007;8:26-34.
Koutros S, Holford TR, Hahn T, Lantos PM, McCarthy PL Jr, Risch HA, Swede H. Excess
diagnosis of non-Hodgkin’s lymphoma during spring in the USA. Leuk Lymphoma
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2007;48:357-66.
2006
Risch HA, McLaughlin JR, Cole DEC, Rosen B, Bradley L, Fan I, Tang J, Li S, Zhang S, Shaw
PA, Narod SA. Population BRCA1 and BRCA2 mutation frequencies and cancer penetrances:
a kin-cohort study in Ontario, Canada. J Natl Cancer Inst 2006;98(23):1694-706.
Risch HA, Bale AE, Beck PA, Zheng W. PGR +331A/G and increased risk of epithelial ovarian
cancer. Cancer Epidemiol Biomarkers Prev 2006;15:1738-41.
Lu L, Katsaros D, Wiley A, Rigault de la Longrais IA, Risch HA, Puopolo M, Yu H. The
relationship of insulin-like growth factor-II, insulin-like growth factor binding protein-3, and
estrogen receptor-alpha expression to disease progression in epithelial ovarian cancer. Clin
Cancer Res 2006;12:1208-14.
Mayne ST, Risch HA, Dubrow R, Chow W-H, Gammon MD, Vaughan TL, Borchardt L,
Schoenberg JB, Stanford JB, West AB, Rotterdam H, Blot WJ, Fraumeni JF Jr. Carbonated
soft drink consumption and risk of esophageal adenocarcinoma. J Natl Cancer Inst
2006;98:72-5.
Beeghly A, Katsaros D, Chen H, Fracchioli S, Zhang Y, Massobrio M, Risch H, Jones B, Yu H.
Glutathione S-transferase polymorphisms and ovarian cancer treatment and survival. Gynecol
Oncol 2006;100:330-7.
2005
Trivers KF, De Roos AJ, Gammon MD, Vaughan TL, Risch HA, Olshan AF, Schoenberg JB,
Mayne ST, Dubrow R, Stanford JL, Abrahamson P, Rotterdam H, West AB, Fraumeni JF Jr,
Chow W-H. Demographic and lifestyle predictors of survival in patients with esophageal or
gastric cancers. Clin Gastroenterol Hepatol 2005;3:225-30.
Antoniou AC, Pharoah PDP, Narod S, Risch HA, Eyfjord JE, Hopper JL, Olsson H, Johannsson
O, Borg Å, Pasini B, Radice P, Manoukian S, Eccles DM, Tang N, Olah E, Anton-Culver H,
Warner E, Lubinski J, Gronwald J, Gorski B, Tulinius H, Thorlacius S, Eerola H, Nevanlinna
H, Syrjäkoski K, Kallioniemi O-P, Thompson D, Evans C, Peto J, Lalloo F, Evans DG, Easton
DF. Breast and ovarian cancer risks to carriers of the BRCA1 5382insC and 185delAG and
BRCA2 6174delT mutations: a combined analysis of 22 population based studies. J Med
Genet 2005;42:602-3.
2004
Gammon MD, Terry MB, Arber N, Chow W-H, Risch HA, Vaughan TL, Schoenberg JB, Mayne
ST, Stanford JL, Dubrow R, Rotterdam H, West AB, Fraumeni JF Jr, Weinstein IB,
Hibshoosh, H. Nonsteroidal anti-inflammatory drug use associated with reduced incidence of
adenocarcinomas of the esophagus and gastric cardia that overexpress Cyclin D1: a
population-based study. Cancer Epidemiol Biomarkers Prev 2004;13:34-9.
2003
Engel LS, Chow W-H, Vaughan TL, Gammon MD, Risch HA, Stanford JL, Schoenberg JB,
Mayne ST, Dubrow R, Rotterdam H, West AB, Blaser M, Blot WJ, Gail M, Fraumeni JF Jr.
Population attributable risks of esophageal and gastric cancers. J Natl Cancer Inst
2003;95:1404-13.
Risch HA. Etiology of pancreatic cancer, with a hypothesis concerning the role of N-nitroso
compounds and excess gastric acidity. J Natl Cancer Inst 2003;95(13):948-60.
Fung WLA, Risch H, McLaughlin J, Rosen B, Cole D, Vesprini D, Narod SA. The N314D
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polymorphism of galactose-1-phosphate uridyl transferase does not modify the risk of ovarian
cancer. Cancer Epidemiol Biomarkers Prev 2003;12:678-80.
Modugno F, Moslehi R, Ness RB, Nelson DB, Belle S, Kant JA, Wheeler JE, Wonderlick A,
Fishman D, Karlan B, Risch H, Cramer DW, Dube M-P, Narod SA. Reproductive factors and
ovarian cancer risk in Jewish BRCA1 and BRCA2 mutation carriers (United States). Cancer
Causes Control 2003;14:439-46.
Modugno F, Ovarian Cancer and High-Risk Women Symposium Presenters. Ovarian cancer and
high-risk women: Implications for prevention, screening, and early detection. Gynecol Oncol
2003;91:15-31.
El-Omar EM, Rabkin CS, Gammon MD, Vaughan TL, Risch HA, Schoenberg JB, Stanford JL,
Mayne ST, Goedert J, Blot WJ, Fraumeni JF Jr, Chow W-H. Increased risk of noncardia
gastric
cancer
associated
with
proinflammatory
cytokine
gene
polymorphisms.
Gastroenterology 2003;124:1193-201.
Antoniou A, Pharoah PDP, Narod S, Risch HA, Eyfjord JE, Hopper J, Loman N, Olsson H,
Johannsson O, Borg Å, Pasini B, Radice P, Manoukian S, Eccles D, Tang N, Olah E, Anton-
Culver H, Warner E, Lubinski J, Gronwald J, Gorski B, Tulinius H, Thorlacius S, Eerola H,
Nevanlinna H, Syrjäkoski K, Kallionemi O-P, Thompson D, Evans C, Peto J, Lalloo F, Evans
DG, Easton DF. Average risks of breast and ovarian cancer associated with BRCA1 or BRCA2
mutations detected in case series unselected for family history: a combined analysis of 22
studies. Am J Human Genet 2003;72:1117-30.
2002
Shaw PA, McLaughlin JR, Zweemer RP, Narod SA, Risch H, Verheijen RHM, Ryan A, Menko
FH, Kenemans P, Jacobs IJ. Histopathologic features of genetically determined ovarian
cancer. Int J Gynecol Pathol 2002;21:407-11.
Engel LS, Vaughan TL, Gammon MD, Chow W-H, Risch HA, Dubrow R, Mayne ST, Rotterdam
H, Schoenberg JB, Stanford JL, West AB, Blot WJ, Fraumeni JF Jr. Occupation and risk of
esophageal and gastric cardia adenocarcinoma. Am J Ind Med 2002;42:11-22.
Ness RB, Cramer DW, Goodman MT, Kjaer SK, Mallin K, Mosgaard BJ, Purdie DM, Risch HA,
Vergona R, Wu A. Infertility, fertility drugs and ovarian cancer: a pooled analysis of case-
control studies. Am J Epidemiol 2002;155:217-24.
2001
Dhillon PK, Farrow DC, Vaughan TL, Chow W-H, Risch HA, Gammon MD, Mayne ST,
Stanford JL, Schoenberg JB, Ahsan H, Dubrow R, West AB, Rotterdam H, Blot WJ, Fraumeni
JF Jr. Family history of cancer and risk of esophageal and gastric cancers in the United States.
Int J Cancer 2001;93:148-52.
Mayne ST, Risch HA, Dubrow R, Chow W-H, Gammon MD, Vaughan TL, Farrow DC,
Schoenberg JB, Stanford JB, Ahsan H, West AB, Rotterdam H, Blot WJ, Fraumeni JF Jr.
Nutrient intake and risk of subtypes of esophageal and gastric cancer. Cancer Epidemiol
Biomarkers Prev 2001;10:1055-62.
Runnebaum IB, Wang-Gohrke S, Vesprini D, Kreienberg R, Lynch H, Moslehi R, Ghadirian P,
Weber B, Godwin AK, Risch H, Garber G, Lerman C, Olipade OI, Foulkes WD, Karlan B,
Warner E, Rosen B, Rebbeck T, Tonin P, Dubé M-P, Kieback DG, Narod SA. Progesterone
receptor variant increases ovarian cancer risk in BRCA1 and BRCA2 mutation carriers who
were never exposed to oral contraceptives. Pharmacogenetics 2001;11:1-4.
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Risch HA, McLaughlin JR, Cole DEC, Rosen B, Bradley L, Kwan E, Jack E, Vesprini DJ,
Kuperstein G, Abrahamson JLA, Fan I, Wong B, Narod SA. Prevalence and penetrance of
germline BRCA1 and BRCA2 mutations in a population series of 649 women with ovarian
cancer. Am J Human Genet 2001;68(3):700-10.
2000
Whiteman DC, Murphy MFG, Cook LS, Cramer DW, Hartge P, Marchbanks PA, Nasca PC, Ness
RB, Purdie DM, Risch HA. Multiple births and risk of epithelial ovarian cancer. J Natl
Cancer Inst 2000;92:1172-7.
Moslehi R, Chu W, Karlan B, Fishman D, Risch H, Fields A, Smotkin D, Ben-David Y,
Rosenblatt J, Russo D, Schwartz P, Tung N, Warner E, Rosen B, Friedman J, Brunet J-S,
Narod SA. BRCA1 and BRCA2 mutation analysis of 208 Ashkenazi Jewish women with
ovarian cancer. Am J Human Genet 2000;66:1259-72.
Shin HR, Kim JY, Ohno T, Cao K, Mizokami M, Risch H, Kim SR. Prevalence and risk factors
of hepatitis C virus infection among Koreans in a rural area of Korea. Hepatol Res
2000;17:185-96.
Eras JL, Saftlas AF, Triche E, Hsu C-D, Risch HA, Bracken MB. Abortion and its effect on risk
of preeclampsia and transient hypertension. Epidemiology 2000;11:36-43.
Farrow DC, Vaughan TL, Sweeney C, Gammon MD, Chow W-H, Risch HA, Stanford JL,
Hansten PD, Mayne ST, Schoenberg JB, Rotterdam H, Ahsan H, West AB, Dubrow R,
Fraumeni JF Jr, Blot WJ. Gastroesophageal reflux disease, use of H2 receptor antagonists, and
risk of esophageal and gastric cancer. Cancer Causes Control 2000;11:231-8.
1999
Wang-Gohrke S, Weikel W, Risch H, Vesprini D, Abrahamson J, Lerman C, Godwin A, Moslehi
R, Olipade O, Brunet J-S, Stickeler E, Kieback DG, Kreienberg R, Weber B, Narod SA,
Runnebaum IB. Intron variants of the p53 gene are associated with increased risk for ovarian
cancer but not in carriers of BRCA1 or BRCA2 germline mutations. Br J Cancer
1999;81:179-83.
Zweemer RP, Shaw PA, Verheijen RHM, Ryan A, Berchuk A, Ponder BAJ, Risch H,
McLaughlin JR, Narod SA, Menko FH, Kenemans P, Jacobs IJ. Accumulation of p53 protein
is frequent in ovarian cancers associated with BRCA1 and BRCA2 germline mutations. J Clin
Pathol 1999;52:372-5.
1998
Risch HA. Hormonal etiology of epithelial ovarian cancer, with a hypothesis concerning the role
of androgens and progesterone. J Natl Cancer Inst 1998;90(23):1774-86.
Narod SA, Risch H, Moslehi R, Dørum A, Neuhausen S, Olsson H, Provencher D, Radice P,
Evans G, Bishop S, Brunet J-S, Ponder BAJ, Klijn JGM. Oral contraceptives and the risk of
hereditary ovarian cancer. The Hereditary Ovarian Cancer Clinical Study Group. N Engl J
Med 1998;339(7):424-8.
Vaughan TL, Farrow DC, Hansten PD, Chow W-H, Gammon MD, Risch HA, Stanford JL,
Schoenberg JB, Mayne ST, Rotterdam H, Dubrow R, Ahsan H, West AB, Blot WJ, Fraumeni
JF Jr. Risk of esophageal and gastric adenocarcinomas in relation to use of calcium channel
blockers, asthma drugs, and other medications that promote gastroesophageal reflux. Cancer
Epidemiol Biomarkers Prev 1998;7:749-56.
Chow W-H, Blaser MJ, Blot WJ, Gammon MD, Vaughan TL, Risch HA, Perez-Perez GI,
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Schoenberg JB, Stanford JL, Rotterdam H, West AB, Fraumeni JF Jr. An inverse relation
between cagA+ strains of Helicobacter pylori infection and risk of esophageal and gastric
cardia adenocarcinoma. Cancer Res 1998;58:588-90.
Farrow DC, Vaughan TL, Hansten PD, Stanford JL, Risch HA, Gammon MD, Chow W-H,
Dubrow R, Ahsan H, Mayne ST, Schoenberg JB, West AB, Rotterdam H, Fraumeni JF Jr, Blot
WJ. Use of aspirin and other non-steroidal anti-inflammatory drugs and risk of esophageal
and gastric cancer. Cancer Epidemiol Biomarkers Prev 1998;7:97-102.
Chow WH, Blot WJ, Vaughan TL, Risch HA, Gammon MD, Stanford JL, Dubrow R, Schoenberg
JB, Mayne ST, Farrow DC, Ahsan H, West AB, Rotterdam H, Niwa S, Fraumeni JF Jr. Body
mass index and risk of adenocarcinomas of the esophagus and gastric cardia. J Natl Cancer
Inst 1998;90:150-5.
1997
Gammon MD, Schoenberg JB, Ahsan H, Risch HA, Vaughan TL, Chow W-H, Rotterdam H,
West AB, Dubrow R, Stanford JL, Mayne ST, Farrow DC, Niwa S, Blot WJ, Fraumeni JF Jr.
Tobacco, alcohol, and socioeconomic status and adenocarcinomas of the esophagus and
gastric cardia. J Natl Cancer Inst 1997;89:1277-84.
Chang S, Risch HA. Perineal talc exposure and risk of ovarian carcinoma. Cancer 1997;79:2396-
401.
Yoo K-Y, Tajima K, Miura S, Takeuchi T, Hirose K, Risch H, Dubrow R. Breast cancer risk
factors according to combined estrogen and progesterone receptor status: a case-control
analysis. Am J Epidemiol 1997;146:307-14.
1996
Risch HA. Estrogen replacement therapy and risk of epithelial ovarian cancer. Gynecol Oncol
1996;63:254-7.
Risch HA, Marrett LD, Jain M, Howe GR. Differences in risk factors for epithelial ovarian
cancer by histologic type: results of a case-control study. Am J Epidemiol 1996;144(4):363-
72.
1995
Risch HA, Howe GR. Pelvic inflammatory disease and the risk of epithelial ovarian cancer.
Cancer Epidemiol Biomarkers Prev 1995;4:447-51.
Risch HA, Howe GR. Menopausal hormone use and colorectal cancer in Saskatchewan: A record
linkage cohort study. Cancer Epidemiol Biomarkers Prev 1995;4:21-8.
1994
Risch HA, Jain M, Marrett LD, Howe GR. Dietary fat intake and risk of epithelial ovarian
cancer. J Natl Cancer Inst 1994;86:1409-15.
Risch HA, Marrett LD, Howe GR. Parity, contraception, infertility and the risk of epithelial
ovarian cancer. Am J Epidemiol 1994;140(7):585-97.
Risch HA, Jain M, Marrett LD, Howe GR. Dietary lactose intake, lactose intolerance, and the
risk of epithelial ovarian cancer in southern Ontario (Canada). Cancer Causes Control
1994;5:540-8.
Narod SA, Madlensky L, Bradley L, Cole D, Tonin P, Rosen B, Risch HA. Hereditary and
familial ovarian cancer in Southern Ontario. Cancer 1994;74:2341-6.
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Risch HA, Howe GR. Menopausal hormone usage and breast cancer in Saskatchewan: A record-
linkage cohort study. Am J Epidemiol 1994;139:670-83.
1993
Risch HA, Howe GR, Jain MJ, Burch JD, Holowaty EJ, Miller AB. Are female smokers at higher
risk for lung cancer than male smokers? A case-control analysis by histologic type. Am J
Epidemiol 1993;138(5):281-93.
Holowaty PH, Miller AB, Baines CJ, Risch HA. Canadian National Breast Screening Study: First
screen results as predictors of future breast cancer risk. Cancer Epidemiol Biomarkers Prev
1993;2:11-9.
Yoo K-Y, Tajima K, Miura S, Yoshida M, Murai H, Kuroishi T, Lee Y, Risch HA, Dubrow R. A
hospital-based case-control study of breast-cancer risk factors by estrogen and progesterone
receptor status. Cancer Causes Control 1993;4:39-44.
1991
Holowaty EJ, Risch HA, Burch JD, Miller AB. Lung cancer in women in the Niagara region,
Ontario: A case-control study. Can J Publ Health 1991;82:304-9.
1990
Jain M, Burch JD, Howe GR, Risch HA, Miller AB. Dietary factors and risk of lung cancer:
Results from a case-control study, Toronto, 1981-1985. Int J Cancer 1990;45:287-93.
1989
Miller AB, Howe GR, Sherman GJ, Lindsay JP, Yaffe MJ, Dinner PJ, Risch HA, Preston DL.
Mortality from breast cancer after irradiation during fluoroscopic examinations in patients
being treated for tuberculosis. N Engl J Med 1989;321:1285-9.
Burch JD, Rohan TE, Howe GR, Risch HA, Hill GB, Steele R, Miller, AB. Risk of bladder
cancer by source and type of tobacco exposure: a case-control study. Int J Cancer
1989;44:622-8.
Howe GR, Burch JD, Chiarelli AM, Risch HA, Choi BCK. An exploratory case-control study of
brain tumors in children. Cancer Res 1989;49:4349-52.
1988
Risch HA, Burch JD, Miller AB, Hill GB, Steele R, Howe GR. Dietary factors and the incidence
of cancer of the urinary bladder. Am J Epidemiol 1988;127(6):1179-91.
Risch HA, Burch JD, Miller AB, Hill GB, Steele R, Howe GR. Occupational factors and the
incidence of cancer of the bladder in Canada. Br J Ind Med 1988;45(6):361-7.
Narod SA, Neri L, Risch HA, Raman S. Lymphocyte micronuclei and sister-chromatid
exchanges among Canadian federal laboratory employees. Am J Ind Med 1988;14:449-456.
Risch HA, Weiss NS, Clarke EA, Miller AB. Risk factors for spontaneous abortion and its
recurrence. Am J Epidemiol 1988;128:420-30.
Robles SC, Marrett LD, Clarke EA, Risch HA. An application of capture-recapture methods to
the estimation of completeness of cancer registration. J Clin Epidemiol 1988;41:495-501.
1987
Burch JD, Craib KJP, Choi BCK, Miller AB, Risch HA, Howe GR. An exploratory case-control
study of brain tumors in adults. J Natl Cancer Inst 1987;78:601-9.
1986
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Baines CJ, Wall C, Risch HA, Kuin JK, Fan IJ. Changes in breast self-examination behaviour in
a cohort of 8214 women in the Canadian National Breast Screening Study. Cancer
1986;57:1209-16.
Sclabassi RJ, Kroin JS, Hinman CL, Risch HA. The effect of cortical ablation on afferent activity
in the cat somatosensory system. Electroenceph Clin Neurophysiol 1986;64:31-40.
1985
Risch HA, Jain M, Choi NW, Fodor JG, Pfeiffer CJ, Howe GR, Harrison LW, Craib KJP,
Miller AB. Dietary factors and the incidence of cancer of the stomach. Am J Epidemiol
1985;122:947-59.
Sclabassi RJ, Hinman CL, Kroin JS, Risch HA. A non-linear analysis of afferent modulatory
activity in the cat somatosensory system. Electroenceph Clin Neurophysiol 1985;60:444-54.
1983
Risch HA, Weiss NS, Lyon JL, Daling JR, Liff JM. Events of reproductive life and the incidence
of epithelial ovarian cancer. Am J Epidemiol 1983;117(2):128-39.
Risch HA. An approximate solution for the standard deterministic epidemic model. Math
Biosciences 1983;63:1-8.
1979
Risch HA. The correlation between relatives under assortative mating for an X-linked and
autosomal trait. Ann Hum Genet 1979;43:151-65.
1977
Sclabassi RJ, Risch HA, Hinman CL, Kroin JS, Enns NF, Namerow NS. Complex pattern evoked
somatosensory responses in the study of multiple sclerosis. Proc IEEE 1977;65:626-33.
Chapters in Books:
Holick CN, Risch HA. Smoking and Ovarian Cancer. In: Tobacco: Science, Policy and Public
Health, second edition, Boyle P, Gray N, Henningfield J, Seffrin J, Zatonski W, eds. New
York: Oxford University Press, pp. 503-11, 2010.
Holick CN, Risch HA. Smoking and Ovarian Cancer. In: Tobacco and Public Health: Science
and Policy, Boyle P, Gray N, Henningfield J, Seffrin J, Zatonski W, eds. New York: Oxford
University Press, pp. 511-21, 2004.
Risch HA. Hormones and Epithelial Ovarian Cancer. In: Proceedings of the Second
International Symposium of the Portuguese Menopause Society, Neves-e-Castro M, Wren BG,
eds. London, UK: Parthenon Publishing Group, pp. 129-40, 2002.
Risch HA. Etiologic Mechanisms in Epithelial Ovarian Cancer. In: Proceedings of the Third
International Symposium on Hormonal Carcinogenesis, Li JJ, Daling JR, Li SA, eds. New
York: Springer Verlag, pp. 307-19, 2000.
Howe GR, Burch JD, Risch HA. Artificial sweeteners, caloric intake and cancer: the
epidemiologic evidence. In: Sweeteners: Health Effects, Williams G, ed. Princeton: Princeton
Scientific Publishers, 1988.
Choi NW, Miller AB, Fodor JG, Jain M, Howe GR, Risch HA, Ruder AM. Consumption of
precursors of N-nitroso compounds and human gastric cancer. In: The Relevance of N-Nitroso
compounds to Human Cancer Exposures and Mechanisms, Bartsch H, O'Neill I, Schulte-
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Hermann R, eds. Lyon: IARC Scientific Publications No. 84, 1987.
Editorials and Other Invited Papers:
Risch HA.
Diabetes and pancreatic cancer: both cause and effect. JNCI J Natl Cancer Inst
2019;111(1):djy093. doi: 10.1093/jnci/djy093
Risch HA. Pancreatic cancer: Helicobacter pylori colonization, N-nitrosamine exposures, and
ABO blood group. Mol Carcinog 2012;51(1):109-18.
Risch HA. It’s time to accept that intake of dairy foods is not related to risk of ovarian cancer.
Nat Clin Pract Oncol 2006;3:472-3.
Risch H. Involvement of dietary factors, Helicobacter pylori, and host inflammatory cytokine
genetic polymorphisms in the etiology of pancreatic carcinoma. Zhong Liu [Tumor]
2003;23:445-7.
Risch HA. Postmenopausal estrogen-only, but not estrogen + progestin, was associated with an
increased risk of ovarian cancer. Evid-Based Obstet Gynecol 2003;5:53-4.
Risch HA.
Hormone replacement therapy and the risk of ovarian cancer. Gyn Oncol 2002;
86:115-7.
Other Papers:
Risch HA. THE AUTHOR REPLIES. Am J Epidemiol 2020;189(11):1444-1449. doi:
10.1093/aje/kwaa152. PMCID: PMC7454297 (letter)
Risch HA. Risch Responds to "How to Consider Low Reported Death Rates in COVID-19". Am J
Epidemiol 2020;189(11):1230-1231. doi: 10.1093/aje/kwaa156. PMCID: PMC7454272 (letter)
Risch HA. Response to: "Overcoming the therapeutic nihilism of out-of-hospital management of
COVID-19 patients". Am J Epidemio. 2020 Dec 16:kwaa275. doi: 10.1093/aje/kwaa275. Online
ahead of print. PMCID: PMC7799246 (letter)
Connecticut Academy of Science and Engineering, Inc. (May 29, 2020). An Adaptive Risk-Based
Strategy for Connecticut’s Ongoing COVID-19 Response [White Paper]. Retrieved from
https://www.ctcase.org/reports/Adaptive%RiskBased%Approach.pdf
Risch HA. Re: NSAID use and pancreatic cancer risk. Gastroenterology 2018;155:931 (letter).
Risch HA. Low-dose aspirin and pancreatic cancer risk—Reply. Cancer Epidemiol Biomarkers Prev
2017;26(7):1155-6 (letter).
Risch HA. Aspirin and pancreatic cancer—Response. Cancer Epidemiol Biomarkers Prev
2017;26(6):979 (letter).
Risch HA, Yu H, Lu L, Kidd MS. Risch et al. respond to “Clinical utility of prediction models for
rare outcomes: The example of pancreatic cancer.”
Am J Epidemiol 2015;182(1):39-40.
(response to invited commentary).
Risch HA, Berchuck A, Pharoah PDP for the Ovarian Cancer Association Consortium. KRAS
rs61764370 in epithelial ovarian cancer—Response. Clin Cancer Res 2011;17:6601 (letter).
Bertuccio P, La Vecchia C, Silverman DT, Petersen GM, Bracci PM, Negri E, Li D, Risch HA, Olson
SH, Gallinger S, Miller AB, Bueno-de-Mesquita HB, Talamini R, Polesel J, Ghadirian P,
Baghurst PA, Zatonski W, Fontham E, Bamlet WR, Holly EA, Lucenteforte E, Hassan M, Yu H,
Kurtz RC, Cotterchio M, Su J, Maisonneuve P, Duell EJ, Bosetti C, Boffetta P. Reply to: Are
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cohort data on smokeless tobacco use and pancreatic cancer confounded by alcohol use? Ann
Oncol 2011;22:1931-2. (letter).
Risch HA. Cyclin E Overexpression Relates to Ovarian Cancer Histology but Not to Risk Factors.
Cancer Epidemiol Biomarkers Prev 2008;17:1841 (letter).
Zhang Y, Zhu Y, Risch HA. Changing incidence of thyroid cancer. JAMA 2006;296:1350 (letter).
Mayne ST, Risch HA, Dubrow R, Chow W-H, Gammon MD, Vaughan TL, Fraumeni JF Jr.
Re: “Carbonated Soft Drink Consumption and Risk of Esophageal Adenocarcinoma.”
Response. J Natl Cancer Inst 2006;98:646-7 (letter).
Risch HA, Miller AB. Re: “Are Women More Susceptible to Lung Cancer?” J Natl Cancer Inst
2004;96(20):1560 (letter).
Risch HA. Re: “Etiology of pancreatic cancer, with a hypothesis concerning the role of N-nitroso
compounds and excess gastric acidity.” Response. J Natl Cancer Inst 2004;96:75-6 (letter).
Risch HA, Narod SA. Re: “Cancer risks in BRCA1 carriers: Time for the next generation of
studies.” J Natl Cancer Inst 2003;95:758 (letter).
Risch HA, Narod SA. Re: “On the use of familial aggregation in population-based case probands
for calculating penetrance.” J Natl Cancer Inst 2003;95:73-4 (letter).
Risch HA, Miller AB. Re: “Sex, smoking and cancer: a reappraisal.”
J Natl Cancer Inst
2002;94:308 (letter).
Narod SA, Sun P, Risch HA, for the Hereditary Ovarian Cancer Clinical Study Group. Ovarian
cancer, oral contraceptives, and BRCA mutations. N Engl J Med 2001;345:1706-7 (letter).
Whiteman DC, Murphy MFG, Cook LS, Cramer DW, Hartge P, Marchbanks PA, Nasca PC, Ness
RB, Purdie DM, Risch HA. Re: “Multiple births and risk of epithelial ovarian cancer--
Response.” J Natl Cancer Inst 2001;93:319-20 (letter).
Risch HA. Oral contraceptive use, anovulatory action and risk of epithelial ovarian cancer.
Epidemiology 2000;11:614 (letter).
Risch HA. Re: “Hormonal etiology of epithelial ovarian cancer, with a hypothesis concerning the
role of androgens and progesterone.” Response. J Natl Cancer Inst 1999;91:650-1 (letter).
Risch HA. Re: “Relationship between lifetime ovulatory cycles and overexpression of mutant
p53 in epithelial ovarian cancer.” J Natl Cancer Inst 1997;89:1726-7 (letter).
Risch HA, Howe GR, Jain MJ, Burch JD, Holowaty EJ, Miller AB. Re: “Are female smokers at
higher risk for lung cancer than male smokers? A case-control analysis by histologic type”—
The authors reply. Am J Epidemiol 1994;140:187-8 (letter).
Risch HA, Howe GR, Jain MJ, Burch JD, Holowaty EJ, Miller AB. Lung cancer risk for female
smokers. Science 1994;263(5151):1206-8 (letter).
Risch HA. Re: “Likelihood-based Confidence Limits.” Ann Epidemiol 1992;2:767-9 (letter).
Risch HA. Re: “A simple method to calculate the confidence interval of a standardized mortality
ratio (SMR).” Am J Epidemiol 1991;133:212 (letter).
Risch HA. Re: “Risk factors for spontaneous abortion and its recurrence”—The first author
replies. Am J Epidemiol 1990;131:571-3 (letter).
Miller AB, Risch HA. Diet and lung cancer. Chest--The Cardiopulmonary Journal 1989
(Suppl);96:8s-9s.
Risch HA, Weiss NS, Daling JR, Lyon JL, Liff JM. Re: “Events of reproductive life and the
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incidence of epithelial ovarian cancer”—The authors reply. Am J Epidemiol 1989;129:862-3
(letter).
Risch HA, Tibshirani RJ. Likelihood-based conditional logistic regression methods for
comparing different classes of controls under individual matching to a single case group. Am
J Epidemiol 1988;128:446-8 (letter).
Risch HA.
Book Review: Peter Taylor, The Smoke Ring: Tobacco, Money and Multinational
Politics. J Public Health Policy 1985;6:137-139.
Risch HA. On approximate solutions for the general stochastic epidemic. Ph.D. dissertation,
University of Chicago, 1980.
Risch HA. Functional power series analysis of somatosensory evoked potentials. M.D.
dissertation, University of California at San Diego, 1976.
Published Abstracts:
Cartmel B, Hughes M, Zhou Y, Gottlieb L, Ercolano E, Risch H, Harrigan M, McCorkle R, Irwin
M. Randomized trial of exercise on depressive symptoms in women diagnosed with ovarian
cancer: The women's activity and lifestyle study in Connecticut (WALC). Psychooncology
2018;27(Suppl 1):97. doi:http://dx.doi.org/10.1002/pon.4623
Streicher SA, Klein AP, Olson SH, Kurtz RC, DeWan AT, Zhao H, Risch HA. A pooled
genome-wide association study of pancreatic cancer susceptibility loci in American Jews.
Cancer Res 2017;77(13 Suppl): Abstract 1326. doi:10.1158/1538-7445.AM2017-1326.
Rasmussen CB, Kjaer SK, Albieri V, Webb PM, Risch HA, Rossing MA, Goodman MT,
Moysich KB, Schildkraut JM, Bandera EV, Massuger LFAG, Phelan C, Anton-Culver H,
Pearce CL, Wu AH, Jensen A. Pelvic inflammatory disease and risk of invasive ovarian
cancer and borderline ovarian tumors: A pooled analysis of 13 case-control studies. Int J
Gynecol Obstet 2015;131(Suppl 5):e421.
Prastegaard C, Jensen A, Svane TS, Risch HA, Rossing MA, Chang-Claude J, Goodman MT,
Moysich K, Matsuo K, Goode EL, Terry KL, Schildkraut JM, Massuger LFAG, Bandera EV,
Wentzensen N, Whittemore A, Sutphen R, Anton-Culver H, Menon U, Gentry-Maharaj A, Wu
A, Pearce CL, Webb PM, Kruger Kjaer S. The impact of cigarette smoking on ovarian cancer
survival: A pooled analysis of 20 case control studies from the ovarian cancer association
consortium. Int J Gynecol Obstet 2015;131(Suppl 5):e172.
Zhou Y, Gottlieb L, Cartmel B, Li F, Ercolano EA, Harrigan M, McCorkle R, Ligibel JA, Von
Gruenigen VE, Gogoi R, Schwartz PE, Risch HA, Irwin ML. Randomized trial of exercise on
quality of life and fatigue in women diagnosed with ovarian cancer: The Women's Activity
and Lifestyle study in Connecticut (WALC). J Clin Oncol 2015;33(15 Suppl):9505.
Yang HP, Cook LS, Weiderpass E, Adami H-O, Anderson KE, Cai H, Cerhan JR, Clendenen T,
Felix AS, Friedenreich C, Garcia-Closas M, Goodman MT, Liang X, Lissowska J, Lu L,
Magliocco AM, McCann SE, Moysich KB, Olson SH, Pike MC, Polidoro S, Ricceri F, Risch
H, Sacerdote C, Setiawan VW, Shu XO, Spurdle AB, Trabert B, Webb PM, Wentzensen N,
Xiang Y-B, Xu Y, Yu H, Zeleniuch-Jacquotte A, Brinton LA. Infertility and risk of incident
endometrial carcinoma: a pooled analysis from the Epidemiology of Endometrial Cancer
Consortium. Cancer Res 2014;74(19 Suppl);2167.
Tang H, Duell EJ, Risch HA, Olson SH, Bueno-de-Mesquita HB, Gallinger S, Holly EA, Petersen
GM, Bracci PM, McWilliams RR, Jenab M, Riboli E, Tjønneland A, Boutron-Ruault MC,
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Kaaks R, Trichopoulos D, Panico S, Sund M, Peeters PHM, Khaw K-T, Amos CI, Li D, Wei
P. Genome-wide gene-diabetes and gene-obesity interaction scan in the pancreatic cancer case
control consortium. Cancer Res 2014;74(19 Suppl);2214.
Irwin M, Gottlieb L, Cartmel B, Ercolano E, Rothbard M, Zhou Y, Schwartz PE, Ligibel JA, Von
Gruenigen VE, Risch H. Trial of exercise in ovarian cancer survivors. J Clin Oncol
2012;30(suppl; abstr TPS1614).
Lu L, Katsaros D, Risch H, Yu H. Stem cell-associated gene Lin-28B genotype and phenotype in
epithelial ovarian cancer and their associations with disease survival outcomes. Cancer Res
2012;72(8 Suppl);3655.
Risch HA. Why is pancreatic cancer less frequent in Asia than in the US, in spite of the higher
prevalence of risk factors in Asia? Observations on the etiology of pancreatic cancer. J
Epidemiol 2011;21(Suppl):43-6.
Berchuck A, Pharoah P, Ramus S, Gayther S, Palmieri R, Pearce C, Couch F, Antonio A, Goode E,
Schildkraut J, Chenevix-Trench G, Sellers T, Risch H, for the Consortium of Investigators of
Modifiers of BRCA1/2 and the Ovarian Cancer Association Consortium. Association of KRAS
SNP rs61764370 with risk of invasive epithelial ovarian cancer: Implications for clinical testing.
Gyn Oncol 2011;121:S2-3.
Tsai Y-Y, Chen YA, Chen Z, Permuth-Wey J, Iversen E, Risch H, Barnholtz-Sloan J,
Cunningham JM, Vierkant RA, Fridley BL, Fenstermacher D, Sutphen R, Phelan CM, Narod
SA, Schildkraut JM, Goode EL, Sellers TA. A novel region on 8q24.21 is associated with
ovarian cancer susceptibility. Cancer Res 2011;70:4724. doi:10.1158/1538-7445.AM10-4724
Permuth-Wey J, Tsai Y-Y, Chen YA, Chen Z, Lancaster JM, Iverson E, Risch H, Barnholtz-Sloan
J, Cunningham JM, Vierkant RA, Fridley BL, Fenstermacher D, Sutphen R, Narod SA, Goode
EL, Schildkraut JM, Sellers TA, Phelan CM. Mitochondrial genetic variants influence ovarian
cancer risk. Cancer Res 2011;70:2835. doi:10.1158/1538-7445.AM10-2835
Risch HA. Gene, environment, and risk factor interaction in pancreatic cancer. Cancer Prev Res
2010;3(12 Suppl):ED02-03. doi:10.1158/1940-6207.PREV-10-ED02-03
Ng MT, Rabkin CS, Lochhead P, Lissowska J, Vaughan TL, Gammon M, Risch H, Chow W-H,
Hold GL, El-Omar E. Assessment of novel genetic polymorphisms and risk of upper
gastrointestinal carcinoma. Gastroenterology 2010;138(5)(Suppl 1):S612.
Neale R, Whiteman D, Young J, Fritschi L, Fawcete J, Webb P, Risch H. The Queensland
Pancreatic Cancer Study--Identifying risk factors for pancreatic cancer. Pancreas
2008;36:223.
Vaninetti N, Macdonald K, Geldenhuys L, Risch H, Porter G, Guernsey D, Casson AG. Nitric
oxide in the molecular pathogenesis of Barrett Esophagus and esophageal adenocarcinoma.
Gastroenterology 2007;132(Suppl 2):A635-6.
Engel LS, Vaughan TL, Gammon MD, Chow WH, Risch HA, Dubrow R, Mayne ST, Rotterdam
H, Schoenberg JB, Stanford JL, West AB, Blot WJ, Fraumeni JF. Occupation and risk of
esophageal and gastric cardia adenocarcinoma. Epidemiology 2002;13:S163.
Pharoah P, Antoniou A, Risch H, Narod S, Hopper J, Loman N, Olson H, Johansson O, Borg A,
Pasini B, Radici P, Eccles D, Tang N, Olah E, Anton-Culver H, Eyfjord J, Evans DG, Evans
C, Peto J, Easton D. Average risks of breast and ovarian cancer in women who carry a
BRCA1 or BRCA2 mutation: a preliminary analysis of pooled family data from unselected
case series. Am J Human Genet 2001;69 (Suppl 1):256.
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Ness RB, Cramer DW, Goodman M, Kjaer SK, Mosgaard B, Purdie DM, Risch H, Vergona R,
Wu A. Infertility and ovarian cancer: A pooled analysis. Am J Epidemiol 2001;153:S111.
McLaughlin J, Cole D, Narod S, Rosen B, Risch H. Reproductive and genetic risk factors for
ovarian cancer. Am J Epidemiol 2001;153:S205.
Lew EA, Risch HA, Chow WH, Gammon MD, Vaughan TL, Schoenberg JB, Stanford JL, West
AB, Rotterdam H, Blot WJ, Blaser MJ, Fraumeni JF. Helicobacter pylori, gastroesophageal
reflux, their interrelationships, and the risk of esophageal adenocarcinoma. Gastroenterology
2001;120(Suppl 1):A31.
Lew EA, Risch HA, Chow WH, Gammon MD, Vaughan TL, Schoenberg JB, Stanford JL, Farrow
D, West AB, Rotterdam H, Blot WJ, Fraumeni JF. Epidemiological study of risk factors for
gastric carcinoids. Gastroenterology 2001;120(Suppl 1):A256.
El-Omar EM, Chow WH, Gammon MD, Vaughan TL, Risch HA, Fraumeni JF Jr. Pro-
inflammatory genotypes of IL-1 beta, TNF-alpha and IL-10 increase risk of distal gastric
cancer but not of cardia or oesophageal adenocarcinomas. Gastroenterology 2001;120(Suppl
1):A86.
Saftlas A, Wang W, Risch H, Woolson R, Hsu C, Bracken M. Prepregnancy body mass index
and gestational weight gain as risk factors for preeclampsia and transient hypertension. Ann
Epidemiol 2000;10:475.
Chu W, McLaughlin J, Phelan C, Cole D, Risch H, Narod S. The HRAS1 minisatellite locus
increases the risk of ovarian cancer in BRCA1 carriers, but not in BRCA2 carriers or sporadic
ovarian cancer. Am J Human Genet 2000;67:(Suppl 2):82.
Mayne ST, Risch H, Dubrow R, Chow W-H, Blot W, Gammon M, Vaughan T, Farrow DC,
Schoenberg J, Stanford J, Ahsan H, Fraumeni JF Jr. Nutrient intake and risk of
adenocarcinomas of the esophagus and gastric cardia. FASEB J 1999;13:A1021.
Hibshoosh H, Gammon MD, Rotterdam H, West AB, Terry MB, Vaughan TL, Risch HA, Chow
WH, Fraumeni J, Arber N. Cyclin D1 overexpression in esophageal and gastric carcinoma:
Correlation with histopathology. Lab Invest 1999;79:76A.
Shaw PA, Zweemer RP, McLaughlin J, Narod SA, Risch H, Jacobs IJ. Characteristics of
genetically determined ovarian cancer. Lab Invest 1999;79:124A.
Farrow DC, Vaughan TL, Sweeney C, Gammon MD, Chow W-H, Risch HA, Stanford JL,
Hansten PD, Mayne ST, Schoenberg JB, Rotterdam H, Ahsan H, West AB, Dubrow R,
Fraumeni JF Jr, Blot WJ. Gastroesophageal reflux disease, use of H2 receptor antagonists, and
risk of esophageal and gastric cancer. Ann Epidemiol 1998;8:456.
Farrow DC, Vaughan TL, Hansten PD, Stanford JL, Risch HA, Gammon MD, Chow W-H,
Dubrow R, Ahsan H, Mayne ST, Schoenberg JB, West AB, Rotterdam H, Fraumeni JF Jr, Blot
WJ. Use of aspirin and other non-steroidal anti-inflammatory drugs and risk of esophageal
and gastric cancer. Ann Epidemiol 1998;8:134.
Chow WH, Blot WJ, Vaughan TL, Risch HA, Gammon MD, Farrow DC, Mayne ST, Schoenberg
JB, Fraumeni JF Jr. Body mass index and risk of adenocarcinomas of the esophagus and gastri
cardia. Cancer Epidemiol Biomarkers Prev 1998;7:175.
Vaughan T, Farrow D, Chow W-H, Gammon M, Risch H, Hansten P, Schoenberg J, Mayne S,
Fraumeni J Jr. Risk of esophageal and gastric adenocarcinoma and use of calcium antagonists
and other medications that promote gastroesophageal reflux. Cancer Epidemiol Biomarkers
Prev 1998;7:178.
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Chow WH, Blaser MJ, Blot WJ, Gammon MD, Vaughan TL, Risch HA, Pérez-Pérez GI,
Fraumeni JF Jr. H. pylori and CagA status in relation to risk of adenocarcinomas of esophagus
and stomach by anatomic subsite. Gut 1997;41(Suppl):A33-4.
Abrahamson JLA, Vesprini DJ, Mclaughlin J, Cole D, Rosen B, Bradley L, Robb K, Jack E, Rehal
P, Morris A, Patterson C, Fan I, Brunel JS, Narod SA, Risch HA. High proportion of
germline BRCA1 and BRCA2 mutations in unselected ovarian cancer. Am J Human Genet
1997;61(Suppl):A59.
Risch HA. Estrogen replacement therapy and the risk of epithelial ovarian cancer. Am J
Epidemiol 1996;143:S42.
Risch HA, Howe GR. Pelvic inflammatory disease and the risk of epithelial ovarian cancer. Am
J Epidemiol 1995;141:S24.
Risch HA, Jain M, Marrett LD, Howe GR. Dietary fat intake and the risk of epithelial ovarian
cancer. Am J Epidemiol 1994;139:S37.
Klaus D, Dubrow R, Risch H, Troncale F. Risk of colorectal adenomas and use of nonsteroidal
antiinflammatory drugs (NSAIDS) and acetaminophen (APAP).
Am J Epidemiol
1994;139:S78.
Risch HA, Malcolm E, Howe GR. Cohort study of menopausal hormone usage and breast cancer
in Saskatchewan. Am J Epidemiol 1993;138:610.
Risch HA, Howe GR, Jain MJ, Burch JD, Holowaty EJ, Miller AB. Are female smokers at higher
risk for lung cancer than male smokers? A case-control analysis by histologic type. Am J
Epidemiol 1992;136:1015.
Risch HA. A unified framework for meta-analysis by maximum likelihood. Am J Epidemiol
1988;128:906.
Risch HA. Measuring tumor induction period in case-control studies of chronic exposures. Am J
Epidemiol 1986;124:499.
Research Grants Held:
2020-2025 AP Klein (Principal Investigator), G Petersen, D Li, HA Risch, P Bracci, S Gallinger,
R Hung, M Meng, E Jacobs, J Manjer, M Sund, V Katzke, A Arslan, L Le Marchand,
R Milne, R Stolzenberg-Solomon, C Kooperberg, S van den Eeden, J Genkinger, A
Schwartz, J Brody, S Lynch, A Tjønneland, X-O Shu, L Amundadottir, K Visvanathan,
B Wolpin. Multi-Ancestry Mapping of Pancreatic Cancer Susceptibility Loci.
(National Cancer Institute, $112,843 total direct costs to Yale subcontract over 60
months)
2018-2020 CY Jeon (Principal Investigator), S Freedland, S Kim, NY Kyeong, TK Nuckols, SJ
Pandol, HA Risch, B Spiegel. Predicting the Diagnosis of Pancreatic Cancer by
Leveraging Big Data. (National Cancer Institute, $235,000 total direct costs over 24
months)
2018-2018 ML Irwin (Principal Investigator), L Lu, H Risch. Impact of exercise and diet-induced
weight loss on immunosuppression in breast cancer survivors. (Cynthia Barnett Breast
Cancer Foundation, $25,000 total costs over 12 months)
2017-2018 HA Risch (Principal Investigator), L Lu. Feasibility of circulating exosomal proteins
in ovarian cancer diagnosis. (Brozman Ovarian Cancer Foundation, $25,000 total
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costs over 12 months)
2016-2021 AP Klein (Principal Investigator), P Bracci, S Cleary, S Gallinger, R Hung, D Li, R
Neale, S Olson, G Petersen, HA Risch, G Scelo. Validation and Fine-scale Mapping
of Pancreatic Cancer Susceptibility Loci. (National Cancer Institute, $220,000 total
direct costs to Yale subcontract over 60 months)
2013-2017 Y Guan, X Ma (Principal Investigators), D Zimmerman, P Diggle, T Holford, H Risch,
L Mueller, Y Zhang. New Statistical Methods to Handle Spatial Uncertainty in
Cancer Risk Estimation. (National Cancer Institute, $1,100,000 total direct costs over
48 months)
2011-2016 R Kurman (Principal Investigator), H Berman, L Cope, T Diaz-Montes, M Gauthier, D
Huso, D Levine, E Matloff, S Narod, V Parkash, H Risch, G Rosner, P Shaw, I-M
Shih, R Soslow, R Vang, K Visvanathan, T-L Wang, et al. Prevention of Ovarian
High-Grade Serous Carcinoma by Elucidating Its Early Changes.
(Department of
Defense USMRMC, $9,166,162 total direct costs, of which $199,000 total direct to
Yale epidemiology subcontract, over 60 months).
2011-2015 AP Klein (Principal Investigator), P Bracci, P Brennan, E Duell, S Gallinger, D Li, R
Neale, S Olson, G Petersen, HA Risch.
Validation and Fine-scale Mapping of
Pancreatic Cancer Susceptibility Loci. (National Cancer Institute, $197,000 total
direct costs to Yale subcontract over 48 months)
2011-2013 AP Klein, HA Risch (Co-Principal Investigators). Validation and Fine-Scale Mapping
of Pancreatic Cancer Susceptibility Loci. (National Human Genome Research
Institute, covers costs of large-scale high-throughput genotyping of collaborative
multi-center pancreatic cancer study (see previous grant) at the Center for Inherited
Disease Research (CIDR)).
2010-2016 H Yu (Principal Investigator), M Irwin, X Ma, S Mayne, H Risch, H Zhao, J Lim.
Epidemiologic Study of Hepatocellular Carcinoma in the US. (National Cancer
Institute, $5,385,000 total direct costs over 60 months)
2010-2014 T Sellers (Principal Investigator), A Berchuck, G Bloom, M Clyde, D Fenstermacher,
B Fridley, S Gayther, W Ge, E Goode, E Iversen, H-Y Lin, S Mears, A Monteiro, T
Moorman, L Pearce, P Pharoah, C Phelan, H Risch, MA Rossing, J Schildkraut, G
Trench, Y-Y Tsai. Follow-up of Ovarian Cancer Genetic Association and Interaction
Studies (FOCI). (National Cancer Institute, $108,926 total direct costs to Yale
subcontract 2012-2014)
2010-2013 CL Pearce (Principal Investigator), JA Doherty, S Gayther, VM McGuire, H Risch,
MA Rossing, J Schildkraut, TA Sellers, W Sieh, D Stram, G Trench, P Webb, A
Whittemore, A Wu. Identifying Ovarian Cancer Susceptibility Alleles Using Genome-
Wide Scan Data. (National Cancer Institute, $22,500 total direct costs to Yale
subcontract)
2009-2014 M Irwin (Principal Investigator), J Dziura, R McCorkle, G Mor, H Risch, P Schwartz,
H Yu. Impact of Exercise on Ovarian Cancer Prognosis. (National Cancer Institute,
$2,045,493 total direct costs over 59 months)
2009-2012 T Vaughan, D Whiteman (Principal Investigators), L Bernstein, D Corley, MD
Gammon, L Hardie, N Hayward, G Liu, L Murray, O Nyrén, U Peters, B Reid, HA
Risch, Y Romero, N Shaheen, D Stram, D Van Den Berg, B Weir, A Wu. Barrett’s
and Esophageal Adenocarcinoma Consortium Genetic Susceptibility Study. (National
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Cancer Institute, $3,750,000 total direct costs over 36 months)
2009-2010 M Goodman (Principal Investigator), A Berchuck, J Chang-Claude, D Cramer, CM
Garcia, E Goode, S Krueger Kjaer, R Ness, P Pharoah, HA Risch, M Rossing, R
Sutphen, K Terry, G Trench, A Whittemore. Collaborative Genetic Study of Ovarian
Cancer Risk. (National Cancer Institute, $17,419 total direct costs over 12 months, to
Yale subcontract)
2007-2014 HA Risch (Principal Investigator), Y-T Gao, MS Kidd, H Yu. Case-Control Study of
Pancreas Cancer in Shanghai, China. (National Cancer Institute, $1,858,377 total
direct costs over 75 months)
2007-2012 P Salovey (Principal Investigator), M Irwin, ST Mayne, HA Risch. Promoting Cancer
Prevention/Control with Message Framing: III. Extending Tailored Cancer
Information Service-Delivered Messages Across the Cancer Continuum. (National
Cancer Institute: $1,525,215 total direct costs over 58 months)
2007-2012 R Neale (Principal Investigator), D Whiteman, J Young, L Fritschi, J Fawcett, P Webb,
H Risch.
Case-Control Study of Genetic and Environmental Risk Factors for
Pancreatic Carcinoma. (National Health and Medical Research Council (Australia):
AU$946,475 total nonacademic direct costs over 60 months)
2007-2011 T Sellers (Principal Investigator), D Ballinger, J Barnholtz-Sloan, ME Colter, Y
Huang, E Iversen, J Lancaster, J McLaughlin, S Narod, VS Pankratz, H Risch, J
Schildkraut, R Sutphen. Haplotype-Based Genome Screen for Ovarian Cancer Loci.
(National Cancer Institute, $5,726,016 total direct costs over 60 months)
2006-2007 R Neale (Principal Investigator), D Whiteman, L Fritschi, J Young, J Fawcett, P Webb,
H Risch.
A Case-Control Study of the Environmental and Genetic Causes of
Pancreatic Carcinoma. (Queensland Cancer Fund: AU$258,339 total nonacademic
direct costs over 16 months)
2003-2012 HA Risch (Principal Investigator), FS Gorelick, D Jain, MS Kidd, ST Mayne, MD
Topazian, H Yu. Case-Control Study of Pancreas Cancer Etiologic Factors.
(National Cancer Institute: $2,578,672 total direct costs over 80 months, in NCE)
2003-2010 H Yu (Principal Investigator), HA Risch, ST Mayne, M Irwin, B Cartmel. Role of
Genetic and Lifestyle Interplay in Uterus Cancer. (National Cancer Institute:
$2,185,432 total direct costs over 60 months, in NCE)
2003-2006 SA Narod (Principal Investigator), B Rosen, JR McLaughlin, P Shaw, HA Risch. The
contribution of BRCA2 to ovarian cancer. (National Cancer Institute of Canada:
$375,000 total nonacademic direct costs over 36 months)
2002-2005 H Yu (Principal Investigator), HA Risch.
DNA Methylation, Aging, and Prostate
Cancer Risk. (National Cancer Institute: $600,000 total direct costs over 48 months)
2002-2006 JP Concato (Principal Investigator), W Li, P Peduzzi, HA Risch, D Jain. Risk of
Mortality in Prostate Cancer. (USVA: $424,000 total direct costs over 48 months)
2001-2007 P Salovey (Principal Investigator), HA Risch, ST Mayne, M Morra. Promoting
Cancer Prevention/Control with Message Framing. II. (National Cancer Institute:
$1,324,481 total direct costs over 72 months)
1999-2005 HA Risch (Principal Investigator), AE Bale. DNA Polymorphisms in Ovarian Cancer:
Case-Control Study. (National Cancer Institute: $325,168 total direct costs over 58
months)
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1998-2002 JP Concato (Principal Investigator), W Li, P Peduzzi, S Flynn, C Howe, HA Risch, D
Esrig. Risk of Mortality in Prostate Cancer. (USVA: $425,245 total direct costs over
48 months)
1997-2003 HA Risch (Principal Investigator), L DiPietro, AF Saftlas, A Duleba, ML Carcangiu.
Case-Control Study of Ovarian Cancer Hormonal Etiology. (National Cancer
Institute: $1,445,806 total direct costs over 70 months)
1997-2000 SA Narod (Principal Investigator), HA Risch.
Risk-Factor Analysis of BRCA1 and
BRCA2 Carriers. (National Cancer Institute: $1,228,000 total direct costs over 36
months)
1997-2001 P Salovey (Principal Investigator), HA Risch, M Morra. Promoting Cancer
Prevention/Control with Message Framing. (National Cancer Institute: $498,295 total
direct costs over 48 months)
1996-1999 P Salovey (Principal Investigator), HA Risch, M Morra. Message Framing,
Persuasion, and Cancer Prevention/Detection. (American Cancer Society: $198,000
total direct costs over 24 months)
1994-2000 HA Risch (Principal Investigator), JR McLaughlin, SA Narod, NJ Risch, EJ Holowaty,
BP Rosen, DEC Cole. Genetic-Epidemiology Study of Epithelial Ovarian Tumors.
(National Cancer Institute: $799,551 total direct costs over 69 months)
1994-1997 SA Narod (Principal Investigator), HT Lynch, HA Risch, DE Goldgar. The
Prevention of Hereditary Breast and Ovarian Cancer. (National Cancer Institute:
$356,875 total direct costs over 34 months)
1992-1996 HA Risch (Principal Investigator), ST Mayne, R Dubrow, AB West. Epidemiologic
Study of Esophageal/Gastric Adenocarcinoma. (National Cancer Institute: $536,163
total direct costs over 43 months)
1991-1992 HA Risch (Principal Investigator). Latency-Temporality Analysis in Case-Control
Studies of Chronic Exposures. (National Institutes of Health (BSRG): $19,000 total
direct costs over 12 months)
1990-1991 HA Risch (Principal Investigator), GR Howe, R West, LM Strand. A Record-Linkage
Cohort Study of Menopausal Hormone Usage and Endometrial Cancer in
Saskatchewan. (National Health Research and Development Program, Health and
Welfare Canada: $50,476 total nonacademic direct costs over 8 months)
1990-1994 JAJ Stolwijk (Principal Investigator), HA Risch, ST Mayne, R Dubrow, T Holford.
Cancer Prevention Research Unit for Connecticut at Yale. (National Cancer Institute:
$3,865,000 total direct costs over 60 months)
1989-1993 HA Risch (Principal Investigator), LD Marrett, GR Howe, M Jain. A Case-Control
Study of Dietary Factors and Epithelial Ovarian Cancer. (National Health Research
and Development Program, Health and Welfare Canada: $343,766 total nonacademic
direct costs over 41 months)
1986-1990 GR Howe (Principal Investigator), HA Risch, M Jain, JD Burch, C Wall. Research
Project Support of the NCIC Epidemiology Unit. (National Cancer Institute of Canada:
total nonacademic direct costs $228,093 in 1986-7; $440,454 in 1987-8; $205,617 in
1988-9, etc.)
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Selected Scholarly Presentations and Workshops:
11/20
“Randomized Controlled Trials, Hydroxychloroquine and Risk of Hospitalization and
Mortality in Patients with Covid-19.” Testimony, US Senate Committee on Homeland
Security & Governmental Affairs, Washington, DC.
5/19
“Pancreatic Cancer and Diet.” Pancreatic Cancer Case-Control Consortium (PanC4)
Annual Meeting, Baltimore, MD.
3/19
“Reducing Mortality of What Will Be the #3 Cause of Cancer Death Two Years from
Now.” Virus and Other Infection-associated Cancers Research Seminar, Yale School
of Medicine, New Haven, CT.
5/18
“New Concepts in Causation.” Keynote speaker, Pancreatic Cancer Case-Control
Consortium (PanC4) Annual Meeting, Baltimore, MD.
2/18
"Risk Factors for Pancreatic Cancer." Yale Pancreas Symposium 2018:
Multidisciplinary Management of Pancreatic Cancer. New Haven, CT.
4/17
“Reducing Mortality of what will be the #2 Cause of Cancer Death Four Years from
Now.” Gastroenterologic Oncology Service, Yale Cancer Center, New Haven, CT.
3/17
“Genomewide Association Study of Pancreatic Cancer in American Jews.” Pancreatic
Cancer Case-Control Consortium (PanC4) Annual Meeting, Baltimore, MD.
3/17
“New Markers and Approaches in Predicting Risk of Pancreatic Cancer.” Pancreatic
Cancer Case-Control Consortium (PanC4) Annual Meeting, Baltimore, MD.
12/16
“Genomewide Association Study of Pancreatic Cancer in American Jews.” Pancreatic
Cancer Case-Control Consortium (PanC4) GWAS Study Annual Meeting, Bethesda,
MD.
10/16
“Reducing Mortality of Pancreatic Cancer in the International Context.” Inaugural
Global Oncology Seminar Series speaker, Yale Cancer Center, New Haven, CT.
6/16
“Prevention of Pancreatic Cancer.” Pancreatic Cancer Case-Control Consortium
(PanC4) Annual Meeting, Milan, Italy.
1/16
“Reducing Mortality of what will be the #2 Cause of Cancer Death Five Years from
Now.” Department of Therapeutic Radiation, Yale School of Medicine, New Haven,
CT.
10/15
“Reducing Mortality of what will be the #2 Cause of Cancer Death Five Years from
Now.” Division of Cancer Epidemiology and Genetics, National Cancer Institute,
NIH, Rockville, MD.
3/15
“Absolute Risk Models for Pancreatic Cancer.” Pancreatic Cancer Case-Control
Consortium (PanC4) Annual Meeting, Baltimore, MD.
12/12
Keynote Speaker, “From Cancer Registration to Cancer Etiology to Cancer
Prevention.” Cancer Registrars Association of New England Annual Meeting,
Norwich, CT.
3/12
“Pancreatic Cancer Risk Models.” Pancreatic Cancer Case-Control Consortium
(PanC4) Annual Meeting, Baltimore, MD.
3/12
Cancer Center Grand Rounds: “Helicobacter pylori, ABO Blood Group and the
Etiology of Pancreatic Cancer in China and the US.” Yale University School of
Medicine, New Haven, CT.
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9/11
“Etiology of Pancreatic Cancer: Theory and Evidence.” Seminar, Division of Chronic
Disease Epidemiology, Yale University School of Public Health, New Haven, CT.
3/11
“Genetic Effects and Modifiers of Radiotherapy and Chemotherapy on Survival in
Pancreatic Cancer,” Pancreatic Cancer Case-Control Consortium (PanC4) Annual
Meeting, New York, NY.
1/11
Keynote Speaker, “Why is Pancreatic Cancer Less Frequent in Asia than in the US, in
Spite of the Higher Prevalence of Risk Factors in Asia? Observations on the Etiology
of Pancreatic Cancer.” Japan Epidemiology Association National Meetings, Sapporo,
Japan.
1/11
Department Seminar: “BRCA1 and BRCA2 Mutations: Population Frequencies and
Associations with a Variety of Cancers.” Division of Epidemiology and Prevention,
Aichi Cancer Center Research Institute, Nagoya, Japan.
1/11
Cancer Center Grand Rounds, “Why is Pancreatic Cancer Less Frequent in Asia than
in the US, in Spite of the Higher Prevalence of Risk Factors in Asia? Observations on
the Etiology of Pancreatic Cancer.” Japan National Cancer Center, Tokyo, Japan.
11/10
Educational Session Seminar, “Gene, environment, and risk-factor interaction in
pancreatic cancer.” AACR Frontiers in Cancer Prevention Annual International
Meeting, Philadelphia PA.
11/10
Workshop Presentation: “KRAS variation and risk of ovarian cancer.” Biennial
meeting of the Ovarian Cancer Association Consortium (OCAC), Bethesda, MD.
5/10
Cancer Center Retreat Seminar, “ABO blood group, Helicobacter pylori colonization
and pancreatic cancer.” Yale University School of Medicine, New Haven, CT.
3/10
“Helicobacter pylori colonization, ABO blood group and risk of pancreatic cancer,”
Pancreatic Cancer Case-Control Consortium (PanC4) Annual Meeting, Bethesda, MD.
7/09
Epidemiology Grand Rounds: “Pancreas Cancer and Helicobacter pylori in the U.S.
and China.” Department of Epidemiology, Shanghai Cancer Institute, Shanghai,
China.
3/09
Cancer Center Grand Rounds: “Inconsistencies in Pancreas-Cancer Risk Factors and
Disease Incidence Between the U.S. and China: Observations on the Etiology of
Pancreas Cancer.” Yale University School of Medicine, New Haven, CT.
11/08
Workshop Participant, Defining the Public Health Research Agenda for Ovarian
Cancer, Centers for Disease Control, Atlanta, GA.
7/08
Workshop Presentation: “Helicobacter pylori and pancreas cancer.” Biological and
Clinical Risks and Potential Benefits of Helicobacter pylori Colonization, Division of
Microbiology and Infectious Diseases, NIAID, NIH, Bethesda, MD.
1/08
Research Seminar: “Smoking and lung cancer in women—yet again.” Program in
Cancer Prevention and Control, Yale Cancer Center, New Haven, CT.
11/07
Workshop Presentation: “BRCA1 and BRCA2 Mutations: Frequencies in the General
Population of North America and Associations with Breast, Ovary, Stomach, Pancreas
and Other Cancers.” Nanjing International Symposium of New Frontiers in Cancer
Research and Advanced Training Workshop of Cancer Molecular Epidemiology,
Nanjing Medical University, Nanjing, China.
10/07
Workshop Presentation: “Why have epidemiology data and outcomes of clinical trials
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not correlated?” Third Haifa Cancer Prevention Workshop. CHS National Cancer
Control Center, Faculty of Medicine, Technion Israel Institute of Technology, Haifa,
Israel.
6/07
Workshop: “Advanced Statistical Methods for Epidemiologic Studies”. Department of
Community Medicine and Epidemiology, Technion Israel Institute of Technology
Faculty of Medicine, Haifa, Israel.
3/07
Ruth and Bruce Rappaport Seminar: “Why Pancreas Cancer is Less Frequent in China
than the US, in Spite of the Generally Higher Chinese Prevalence of Risk Factors:
Insights on the Etiology of Pancreas Cancer.” Faculty of Medicine, Technion Israel
Institute of Technology, Haifa, Israel.
2/07
Seminar: “Smoking and lung cancer in women—yet again.” Department of
Community Medicine and Epidemiology, Technion Israel Institute of Technology
Faculty of Medicine, Haifa, Israel.
1/07
Seminar: “Etiologic theories for epithelial ovarian cancer.” Department of Community
Medicine and Epidemiology, Technion Israel Institute of Technology Faculty of
Medicine, Haifa, Israel.
11/06
Seminar: “BRCA1 and BRCA2 Mutations: Frequencies in the General Population and
Associations with Breast, Ovary, Stomach, Pancreas and Other Cancers.” New York
University Cancer Center, New York, NY.
2/06
Cancer Center Grand Rounds: “BRCA1 and BRCA2 Mutations: Their Frequencies in
the General Population and Their Associations with Breast, Ovary, Stomach, Pancreas
and Other Cancers,” Yale University School of Medicine, New Haven, CT.
11/05
Symposium: "Why Pancreas Cancer is Less Frequent in China than the US, in spite of
the Generally Higher Chinese Prevalence of Risk Factors: Insights on the Etiology of
Pancreas Cancer." Clinical Oncological Society of Australia annual scientific meeting,
Brisbane, Australia (Sponsored by the Queensland Cancer Fund).
11/05
Symposium: "Risks and penetrances of germline BRCA1 and BRCA2 mutations for
ovarian, breast, stomach, pancreas and other cancers: updated results from the Ontario
(Canada) ovarian cancer kin-cohort study." Clinical Oncological Society of Australia
annual scientific meeting, Brisbane, Australia (Sponsored by the Queensland Cancer
Fund).
6/05
Seminar: "Why Pancreas Cancer is Less Frequent in China than the US, in spite of the
Generally Higher Chinese Prevalence of Risk Factors: Insights on the Etiology of
Pancreas Cancer." Tumor Registrars Association of Connecticut Quarterly Meeting,
Yale-New Haven Hospital, New Haven, CT.
5/05
Seminar: "Why Pancreas Cancer is Less Frequent in China than the US, in spite of the
Higher Prevalence of Risk Factors There: Insights on the Etiology of Pancreas
Cancer." Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL.
5/02
Symposium: "Genetic Epidemiology of Ovarian Cancer." Ovarian Cancer and High-
Risk Women: Implications of Prevention, Screening and Early Detection. University
of Pittsburgh, Pittsburgh, PA.
12/01
Seminar: "Prevalence and Penetrance of Germline BRCA1 and BRCA2 Mutations in
Unselected Ovarian Cancer." Kaplan Cancer Center, NYU School of Medicine, New
York, NY.
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10/01
Research Seminar: "Prevalence and Penetrance of Germline BRCA1 and BRCA2
Mutations in Unselected Ovarian Cancer." Memorial Sloan Kettering Cancer Center,
New York, NY.
6/01
Combined Monthly Research Seminar: "Prevalence and Penetrance of Germline
BRCA1 and BRCA2 Mutations in Unselected Ovarian Cancer." Programs in Ovarian
Cancer, Cancer Genetics and Cancer Prevention, Yale Cancer Center, New Haven, CT.
10/00
Departmental Seminar: "Etiology of Epithelial Ovarian Cancer." Department of Public
Health Sciences, Fox Chase Cancer Center, Philadelphia, PA.
9/98
"Etiologic Mechanisms in Epithelial Ovarian Cancer," Third International Symposium
on Hormonal Carcinogenesis, Seattle, WA.
5/98
Departmental Grand Rounds: "BRCA1 and BRCA2 Mutations in Unselected Ovarian
Cancer," Department of Gynecologic Oncology, Yale University School of Medicine,
New Haven, CT.
9/97
Departmental Seminar: "Etiologic Mechanisms in Epithelial Ovarian Cancer."
Division of Epidemiology, Columbia University School of Public Health, New York,
NY.
9/97
"Use of aspirin and other non-steroidal anti-inflammatory drugs and risk of esophageal
and gastric cancer." American College of Epidemiology Annual Meetings, Cambridge,
MA.
3/97
"Risk Factors for Familial and Hereditary Ovarian Cancer." American Cancer Society
Science Writers Seminar, Reston, VA.
2/97
Departmental Grand Rounds: "Etiologic and Histologic Considerations in the
Occurrence of Ovarian Cancer." Department of Pathology, Yale School of Medicine,
New Haven, CT.
1/97
Departmental Seminar: "Ovarian Cancer Pathophysiology: Etiologic and Methodologic
Issues." Department of Epidemiology, University of North Carolina School of Public
Health, Chapel Hill, NC.
6/96
"Risk factors for BRCA1-associated ovarian cancer." NCI Extramural Genetic
Epidemiology PIs Second Biennial Meetings, Frederick, MD.
6/96
"Estrogen replacement therapy and the risk of epithelial ovarian cancer." Society for
Epidemiologic Research Annual Meetings, Boston, MA.
6/95
"Pelvic inflammatory disease and the risk of epithelial ovarian cancer." Society for
Epidemiologic Research Annual Meetings, Snowbird, UT.
6/94
"Dietary fat intake and the risk of epithelial ovarian cancer." Society for
Epidemiologic Research Annual Meetings, Miami, FL.
6/93
"A cohort study of menopausal hormone usage and breast cancer in Saskatchewan."
Society for Epidemiologic Research Annual Meetings, Keystone, CO.
2/93
"A cohort study of menopausal hormone usage and breast cancer in the province of
Saskatchewan, Canada." International Epidemiology Association Regional European
Meeting, Jerusalem.
9/92
"A record-linkage cohort study of menopausal hormone usage and breast cancer in
Saskatchewan." American College of Epidemiology Annual Meetings, Bethesda, MD.
9/92
"Record-linkage cohort study of menopausal hormone usage and breast cancer."
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Yale/Dana Farber Conference on Cancer Prevention and Control, Department of
Epidemiology and Public Health, Yale University, New Haven, CT.
6/92
"Are female smokers at higher risk for lung cancer than male smokers? A case-control
analysis by histologic type." Society for Epidemiologic Research Annual Meetings,
Minneapolis, MN.
12/91
Departmental Seminar: "Some interesting results on lung cancer in women."
Department of Epidemiology and Public Health, Yale University, New Haven, CT.
11/89
Departmental Seminar: "Occupational and dietary associations with bladder-cancer
incidence." Department of Epidemiology and Public Health, Yale University, New
Haven, CT.
8/89
"A demonstration of the GLIMP computer program for epidemiologic analysis."
Canadian Epidemiology Research Conference Meetings, Ottawa.
4/89
"Nonlinear dose-response models with standard logistic regression." Upstate New
York and Southern Ontario Epidemiology Group Meetings, Toronto.
6/88
"A unified framework for meta-analysis by maximum likelihood." Society for
Epidemiologic Research Annual Meetings, Vancouver.
4/88
Departmental Seminar: "Occupational and dietary factors in the study of cancer of the
bladder." Division of Epidemiology and Biostatistics, Graduate School of Public
Health, San Diego State University, San Diego, CA.
3/88
Seminar: "Diet and occupation in the causation of bladder cancer." School of Public
Health, New York State Department of Health, SUNY, Albany, NY.
12/87
Departmental Seminar: "Dietary and occupation factors in a case-control study of
bladder cancer." Department of Epidemiology, Harvard School of Public Health,
Boston, MA.
12/87
Departmental Seminar: "Risk factors for spontaneous abortion and its recurrence, and
habitual abortion." Department of Medical Genetics, Hospital for Sick Children,
Toronto.
11/87
Departmental Seminar: "Occupational and dietary factors in the causation of bladder
cancer." Department of Social and Preventive Medicine, SUNY School of Medicine,
Buffalo, NY.
11/87
Departmental Seminar: "Dietary and occupational factors in the study of bladder
cancer." Department of Epidemiology and Biostatistics, University of Western
Ontario, London.
9/87
Departmental Seminar: "Dietary and occupational factors in a case-control study of
bladder cancer." Department of Epidemiology and Community Medicine, University
of Ottawa.
11/86
Departmental Seminar: "Application of linear structural hypotheses in observational
epidemiologic studies." Department of Environmental and Occupational Medicine,
Mount Sinai School of Medicine, New York, NY.
9/86
Departmental Seminar: "Application of linear structural equations in observational
epidemiologic studies." Department of Epidemiology and Public Health, Yale
University, New Haven, CT.
6/86
"Measuring tumor induction period in case-control studies of chronic exposures."
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Society for Epidemiologic Research Annual Meetings, Pittsburgh, PA.
8/84
"Nitrate and ascorbate in a study of gastric cancer." International Epidemiology
Association Meetings, Vancouver.
5/84
"An improved method for obtaining confidence intervals of the odds ratio in logistic
regression." Epidemiologic Methods Workshop, Upstate New York and Southern
Ontario Epidemiology Group Meetings, Toronto.
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 110 of 633 PageID 836
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 110 of 633 PageID 836
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 111 of 633 PageID 837
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 111 of 633 PageID 837
Curriculum Vitae of Thomas Jefferson, MD MRCGP FFPHM
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 112 of 633 PageID 838
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 114 of 633 PageID 840
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 114 of 633 PageID 840
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 115 of 633 PageID 841
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 115 of 633 PageID 841
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 116 of 633 PageID 842
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 117 of 633 PageID 843
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 117 of 633 PageID 843
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App000116
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 118 of 633 PageID 844
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 118 of 633 PageID 844
7
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App000117
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 119 of 633 PageID 845
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 119 of 633 PageID 845
8
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App000118
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 120 of 633 PageID 846
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 120 of 633 PageID 846
9
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App000119
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 121 of 633 PageID 847
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 121 of 633 PageID 847
10
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App000120
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 122 of 633 PageID 848
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 122 of 633 PageID 848
11
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App000121
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 123 of 633 PageID 849
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 123 of 633 PageID 849
12
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App000122
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 124 of 633 PageID 850
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 124 of 633 PageID 850
13
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App000123
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 125 of 633 PageID 851
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 125 of 633 PageID 851
14
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App000124
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 126 of 633 PageID 852
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 126 of 633 PageID 852
15
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App000125
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 127 of 633 PageID 853
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 127 of 633 PageID 853
16
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App000126
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 128 of 633 PageID 854
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 128 of 633 PageID 854
17
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App000127
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 129 of 633 PageID 855
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 129 of 633 PageID 855
18
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App000128
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 130 of 633 PageID 856
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 130 of 633 PageID 856
19
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App000129
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 131 of 633 PageID 857
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 131 of 633 PageID 857
20
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App000130
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 132 of 633 PageID 858
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 132 of 633 PageID 858
21
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App000131
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 133 of 633 PageID 859
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 133 of 633 PageID 859
22
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App000132
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 134 of 633 PageID 860
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 134 of 633 PageID 860
23
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App000133
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 135 of 633 PageID 861
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 135 of 633 PageID 861
24
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App000134
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 136 of 633 PageID 862
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 136 of 633 PageID 862
25
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App000135
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 137 of 633 PageID 863
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 137 of 633 PageID 863
26
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App000136
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 138 of 633 PageID 864
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 138 of 633 PageID 864
27
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App000137
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 139 of 633 PageID 865
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 139 of 633 PageID 865
28
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App000138
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 140 of 633 PageID 866
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 140 of 633 PageID 866
29
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App000139
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 141 of 633 PageID 867
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 141 of 633 PageID 867
30
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App000140
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 142 of 633 PageID 868
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 142 of 633 PageID 868
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App000141
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App000142
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 144 of 633 PageID 870
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App000143
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 145 of 633 PageID 871
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App000144
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 146 of 633 PageID 872
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App000145
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App000146
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37
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Curriculum Vitae of Peter McCullough, MD, MPH
(Exhibit A to McCullough Declaration)
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Tuesday, October 6, 2021
CURRICULUM VITAE
PETER A. McCULLOUGH, MD, MPH, FACC, FCCP, FAHA, FNKF, FNLA, FCRSA
Business
HeartPlace
3409 Worth Street, #500
Dallas TX 75246
Desk: 214-841-2000
Cell: 248-444-6905
e-mail: PeterAMcCullough@gmail.com
Home
5231 Richard Avenue
Dallas, TX 75206
Birth date
December 29, 1962
Birthplace
Buffalo, NY, USA
EDUCATION
1) Certificate of Graduate Liberal Arts Studies: Southern Methodist University, December 17,
2016, principal faculty Dr. Anthony Picchioni, PhD, Adjunct Professor in Human
Development, P.O. Box 750181, Dallas, TX 75275, 214-768-3417, www.smu.edu
x
Graduated with Honor
2) Master of Public Health: University of Michigan School of Public Health, August 19, 1994,
Dean Noreen M. Clark, PhD, 109 Observatory Street, Ann Arbor, MI 48109-2029, phone
734-764-5454, www.sph.umich.edu
x
Major: General Epidemiology
3) Doctor of Medicine: University of Texas Southwestern Medical School, June 4, 1988, Dean
Bryan M. Williams, MD, 5323 Harry Hines Boulevard, Dallas, TX 75235-9070, 214-648-3111,
http://www.utsouthwestern.edu/education/medical-school/
x
Clinical year rank of 1 in 199, overall rank in class of 12 in 199
x
Alpha Omega Alpha Texas Gamma Chapter, installed March 17, 1988
4) Bachelor of Science: Baylor University, May 18, 1984, Chancellor Abner McCall, PhD, Office
of the Registrar, Waco, TX 76798-7056, 254-710-1181, http://www.baylor.edu/
x
Double-major: Biology and Psychology
x
Graduated with Honor, degree rank of 29 in 131, university rank of 127 in 1,152
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x
Alpha Lambda Delta Freshman Honorary, installed March 19, 1981
POSTGRADUATE TRAINING
1) Cardiovascular Diseases Fellowship: William Beaumont Hospital (WBH) (presently Oakland
University William Beaumont School of Medicine), Division of Cardiology, 3601 W. Thirteen
Mile Rd, Royal Oak, MI 48073, 248-551-4198, 7-1-94 to 6-30-97, Chief Cardiovascular
Fellow for 1996-97, William W. O’Neill, MD, Program Director and Division Chief
2) Internal Medicine Residency: University of Washington School of Medicine, Department of
Internal Medicine, 1959 NE Pacific, Seattle, WA 98195, (206) 543-3239, 3-year traditional
track, 7-1-88 to 6-30-91, James F. Wallace, MD, Program Director, Paul G. Ramsey, MD,
Chairman of Medicine
PROFESSIONAL EXPERIENCE
HeartPlace , 3409 Worth Street, Suite 500, Dallas TX 75246, March 1, 2021.
Positions Held: 1) Attending Physician
Baylor Scott and White Health, Baylor Health Care System, Baylor University Medical Center
(BUMC), Baylor Heart and Vascular Institute, Baylor Jack and Jane Hamilton Heart and Vascular
Hospital, Dallas TX, Texas A & M University College of Medicine, Department of Medicine,
Division of Cardiology, Baylor Heart and Vascular Institute, 621 N. Hall St., #H030, Dallas, TX
75226, February 3, 2014 to February 25, 2021. Cardiovascular Governance Council, Kevin
Wheelan, MD, Cardiology Division Chief and Chief Medical Officer, Heart Institute Office (214)
820-7500
Positions Previously Held:
1) Professor in the Principal Faculty, Non-Tenure Track in the Department of
Internal Medicine, Texas A & M University Health Sciences Center (2016-
2021)
2) Chief of Cardiovascular Research (2014-2021)
3) Program Director, BUMC Cardiovascular Diseases Fellowship Program
(2014-2021)
4) Vice Chief, BUMC Internal Medicine (2016-2021)
St. John Providence Health System, Providence Park Heart Institute, Department of Medicine,
Cardiology Section, 47601 Grand River Avenue, Suite B-125, Novi, MI 48374, September 1,
2010 to July 19, 2013. Department of Medicine Chair, Anibal Drelichman, MD: 248-849-3152,
Cardiology Section Chief: Shukri David, MD, 248-465-5955
Positions Previously Held:
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1) Chief Academic and Scientific Officer (Academic Dean Equivalent), St. John
Providence Health System, (2010 to 2013)
2) Medical Director, Clinical Lipidology, Department of Medicine, Cardiology
Section (2010 to 2013)
William Beaumont Hospital, Department of Internal Medicine, Divisions of Nutrition and
Preventive Medicine, Department of Cardiology, 3601 West Thirteen Mile Road, Royal Oak, MI
48073, October 1, 2002 to 2010. Department of Medicine Chair: Michael A. Maddens, M.D.,
248-551-0622, Department of Cardiology Chair: David E. Haines, M.D., 248-858-0404
Oakland University William Beaumont School of Medicine, 472 O'Dowd Hall
2200 N. Squirrel, Rochester, MI 48309, Robert Folberg, MD, Medical School Dean, Kenneth
Hightower, PhD, Dean of Allied Health Sciences, 248-370-3562. Clinical Professor of Health
Sciences and Medicine (2007 to 2010)
Positions Previously Held:
1) Consultant Cardiologist and Chief, Division of Nutrition and Preventive
Medicine (2002 to 2010), Department of Internal Medicine
2) Medical Director, Preventive Cardiology (2002 to 2010)
3) Medical Director, Lipid Apheresis Program (2007 to 2010)
4) Medical Director, Weight Control Center (2002-2005)
University of Missouri-Kansas City (UMKC) School of Medicine, Truman Medical Center,
Department of Medicine, Cardiology Section, 2301 Holmes St., Kansas City, MO 64108. August
18, 2000-September 30, 2002. Department of Medicine Chair: George R. Reisz, M.D, 816-556-
3450
Positions Previously Held:
1) Associate Professor of Medicine (Tenure Track) and Cardiology Section
Chief (2000-2002)
Henry Ford Health System (HFHS), Henry Ford Heart and Vascular Institute, 2799 W. Grand
Blvd., K-14, Detroit, MI 48202, July 1, 1997 to August 16, 2000. Cardiovascular Division Head:
W. Douglas Weaver, M.D, 800-653-6568
Positions Previously Held:
1) Assistant Professor of Medicine (Tenure Track), Case Western Reserve
University School of Medicine, and HFHVI Senior Staff Cardiologist
Medical Director, Preventive Cardiology, 1999-2000
2) Program Director, Cardiovascular Diseases Fellowship Training Program,
1999-2000
3) Director of Cardiovascular Informatics Section, 1997-2000
4) Associate Director of the Center for Clinical Effectiveness, 1997-99
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5) Associate Director of the Cardiovascular Diseases Fellowship Program,
1998-99
Emergency Physicians Medical Group, PC, 2000 Green Road, Suite 300, Ann Arbor, MI 48105,
800-466-3764. Emergency medicine attending at Mission Health McPherson Hospital, Howell,
1991-1997; Oakwood Beyer Hospital Center, Ypsilanti 1991-1997, and Mercy Hospital, Grayling
1991-1992
Positions Previously Held:
1) Associate Member
2) Washtenaw County Human Services Deputy Medical Examiner, 1995-1996
Mercy Internal Medicine Associates, 308 Michigan Avenue, Grayling, MI 49738, Mercy
Hospital-Grayling, 1100 Michigan Avenue, Grayling, MI 49738, 517-348-5461. Internal
medicine attending at Mercy Hospital, Grayling, MI, 1991-1992
Positions Previously Held:
1) Coronary Care Unit Director
2) Physician Director of Cardiopulmonary Services
SPECIAL TRAINING
1) The Healthcare Forum Cardiovascular Health Fellowship, 1998-99
2) American Heart Association (AHA), 23rd 10-Day U.S. Seminar on the Epidemiology and
Prevention of Cardiovascular Disease, July-August, 1997
3) University of Michigan Summer Session in Epidemiology, 1997-99
4) Stanford University Course on Medical Informatics, Palo Alto, CA, June, 1997
5) Current Practice of Vascular Ultrasound 3-Day Course, Chicago, IL, April, 1997
6) Advanced Pacemaker Concepts Course, CPI, Inc., Lansing, MI, 1995
7) Pacesetter Comprehensive Pacemaker 4-Day Course, Santa Fe, NM, 1997
8) Medtronic Bakken Education Tutorial and Medtronic Applied Physiological Research
Laboratory Lead Implantation Training and Biventricular Implantation Training (2 sessions),
Minneapolis, MN, 2001-2002
9) 2004 ASCeXAM Review Course, American Society of Echocardiography, San Francisco, CA,
April 22-24, 2004
10) National Lipid Association Masters Course in Clinical Lipidology, Hilton Head, SC, August 21-
23, 2008
CERTIFICATION AND LICENSURE
1) Licensed in the State of Washington 1988-1997 (#MD00027562), Michigan expires January
31, 2022 (#4301058147), and New York 1992 to present (#189283 inactive status), Missouri
2000-2002 (#2000165365 inactive status) and Texas expires May 31, 2022 (#P9222)
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2) FLEX passed April 4, 1990, State of Washington, Department of Health, Board of Medical
Examiners
3) Diplomate, American Board of Internal Medicine, Candidate #136084, September, 25, 1991,
recertified May 1, 2001, recertified June 10, 2011, recertified April 6, 2021, valid through
2031, 510 Walnut Street, Suite 1700, Philadelphia, PA 19106-3699
4) Diplomate, American Board of Internal Medicine, Cardiovascular Diseases Subspecialty,
Candidate #136084, November, 1997, valid through 2007, recertified October 1, 2007, valid
through 2017, recertified September 28, 2017, valid through 2027, 510 Walnut Street, Suite
1700, Philadelphia, PA 19106-3699
5) Diplomate, American Board of Clinical Lipidology, September 27, 2008, 6816 Southpoint
Parkway, Suite 1000, Jacksonville, FL 32216. Fellow, National Lipid Association
6) National Board of Echocardiography (NBE), Examination of Special Competence in Adult
Echocardiography, 2004-2014 expired
7) Diplomate, American Board of Forensic Examiners, July 16, 1996, no expiration date
RECOGNITION
Teaching:
1. Henry Ford Hospital, 1999 Chief Medical Resident's Best Teacher Award
Research:
1. Chest Foundation Young Investigator Award 2001, Philadelphia, PA, November 7, 2001,
President’s International Awards Ceremony
2. National Kidney Foundation (NKF) of Michigan, Innovations in Health Care Award Finalist
2008, East Lansing, MI, April 17, 2008
3. American College of Cardiology (ACC) Simon Dack Award for Scholarly Excellence by the
Journal of the American College of Cardiology, March 5, 2009
4. 11th International Vicenza Award in Critical Care Nephrology, International Renal Research
Institute, Vicenza, Italy, June 11, 2013
Postgraduate:
1. Founding Fellow, Cardiorenal Society of America, March 2016
2. Fellow, National Lipid Association, January, 2013
3. Fellow, National Kidney Foundation, January, 2012
4. Fellow, American College of Chest Physicians, February, 2001
5. Fellow, American College of Physicians, January, 2001 to September, 2021
6. Fellow, American College of Cardiology, February, 1999
AFFILIATIONS
1) Alpha Omega Alpha, National Honor Medical Society, 1988 to present
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2) American College of Emergency Physicians, Member, 1992-1994
3) American College of Forensic Examiners, Member 1996 to present
4) AHA, Council on Epidemiology and Prevention, 1995 to present
5) AHA, Grassroots Network, 1998-2000.
6) Central Society for Clinical Research, Member, 1999-2000
7) Council on Geriatric Cardiology, Member 1996-1997
8) Michigan Chapter of the ACC, Chair, Annual Cardiology Board Review, 1999-2000
9) Michigan State Medical Society, Member, 1997-2000, 2004 to 2009
10) The American Medical Informatics Association, 1997-2000
11) The Health Forum, Charter Cardiovascular Health Charter Alumni Representative, 1998 to
2002
12) Cardiorenal Society of America, Founding Executive Board Member, 2013 to present, Vice
President 2014-2016, President 2016 to present
13) Dallas County Medical Society, 2014 to present
14) Texas Medical Association, 2014 to present
15) Baylor Alumni Association, 2015 to present
16) New York Academy of Sciences, 2016 to present
17) Truth for Health Foundation, Founding Executive Board Member, Chief Medical Advisor,
2021 to present
EDITORIAL RESPONSIBILITIES
1) Advances in Chronic Kidney Disease, Editorial Board Member, 2003-present. [referenced
through Elsevier Bibliographic Database, EMBASE/Excerpta Medica, MEDLINE]
2) American Journal of Cardiology, Associate Editor, 2014 to present
3) American Journal of Kidney Disease, [referenced through Elsevier Bibliographic Database,
EMBASE/Excerpta Medica, MEDLINE] Associate Editor, 2006 to 2019, Guest Editor, 2011,
2012
4) Arquivos Brasileiros de Cardiologia, International Editorial Board, 2006 to present
5) Biocritique, Editorial Board, 2001 to 2013, www.biocritique.com
6) Blood Purification, Editorial Board 2018 to present
7) Cardiovascular Clinician, Editorial Board, 2011 to 2013, internet site,
CARDIOVASCULARClinician.com™
8) Cardiovascular Diagnosis and Therapy (CDT), Editorial Board (Print ISSN: 2223-3652; Online
ISSN: 2223-3660, 2012 to present
9) Cardiovascular Innovations and Applications (CVIA), Editorial Board 2015 to present
10) Cardiorenal Medicine, Associate Editor, 2016-2017, Editor-in-Chief 2018 to 2021
11) Circulation, Editorial Board, 2016 to present
12) Circulation Heart Failure, Editorial Board, 2008 to present, Associate Editor, 2008 to 2016,
Guest Editor 2010, 2011, 2012
13) Clinical Exercise Physiology, Clinical Consultant to the Editorial Board, 1998-2002.
14) Cochrane Renal Group Module, 2008, Editorial Contributor, Centre for Kidney Research, The
Children’s Hospital at Westmead, Westmead NSW, Australia
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15)
Expert Review of Cardiovascular Therapy, Editorial Advisory Panel, 2002 to present,
www.future-drugs.com
16)
Journal of the American College of Cardiology, Editorial Consultant, 2003-present. “Elite
Reviewer” Recognition, 2004, 2005, 2006, 2007, 2008, 2011, 2014, 2016 (DeMaria AN. The elite
reviewer. J Am Coll Cardiol 2003;41(1):157-8.)
17) Journal of Geriatric Cardiology, Editorial Board Member, 2003-present. The Institute of
Geriatric Cardiology, Chinese PLA Hospital, Beijing. [Joint China-U.S.A. publication]
18) Journal of Biorepository Science for Applied Medicine, Honorary Editorial Board, 2012 to
2018
19) Journal of Clinical & Experimental Cardiology, OMICS Publishing Group, Open Access,
CrossRef, PubMed, DOAJ, Index Copernicus, Scientific Commons, EBSCO, 2010 to 2017
20) Journal of Diabetes & Metabolism, OMICS Publishing Group, Open Access, 2010 to 2017
21) Journal of Interventional Cardiology, “News and Views”, Section Editor, 2000-2003.
Editorial Board Member, 2003 to present
22) Journal of Nephrology and Therapeutics, Editorial Board, OMICS Publishing Group, Editorial
Board, 2010 to 2017
23) Reviews in Cardiovascular Medicine, MedReviews, LLC, www.medreviews.com “Cardiorenal
Function,” Section Editor, 2001-2002, Associate Editor, 2003-2009, Co-Editor, 2009 to
present
24) The American College of Cardiology Foundation ACCEL Audio Journal, Editorial Board 2008
to present
25) The Open Atherosclerosis & Thrombosis Journal, [referenced through Bentham Open,
PubMed, Google and Google Scholar] Editorial Board, 2008 to 2012
26) The Open Heart Failure Journal, [referenced through Bentham Open, PubMed, Google and
Google Scholar] Editorial Board, 2008 to 2010
27) Therapy, [referenced through Elsevier Bibliographic Database, EMBASE/Excerpta Medica,
MEDLINE], Editorial Board, 2008 to 2010
Manuscript Reviewer
1) Advances in Chronic Kidney Disease, 2004 to present (18)
2) Advances in Medical Sciences, 2012 to present (2)
3) Advances in Therapy, 2008 to present (1).
4) American Family Physician, 2004 to present (2)
5) American Journal of Cardiovascular Drugs, 2002 to present. (2)
6) American Heart Journal (AHJ), 1998 to present (22)
7) American Journal of Cardiology (AJC), 1999 to present (60)
8) American Journal of Human Biology, 2014 to present (1)
9) American Journal of Hypertension, 2011 to present (1)
10) American Journal of Kidney Diseases (AJKD), 2002 to present (30)
11) American Journal of Medicine (AJM), 1997 to present (7)
12) American Journal of the Medical Sciences (AJMS), 2006 to present (3)
13) American Journal of Nephrology, 2004 to present (24)
14) American Journal of Physiology: Renal Physiology, 2006 to present (2)
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15) American Journal of Transplantation, 2004 to present (1)
16) Annals of Epidemiology, 2004 to present (1)
17) Annals of Internal Medicine, 2008 to present (3)
18) Annals of Noninvasive Electrocardiology, 2009 to present (1)
19) Antimicrobial Agents and Chemotherapy, 2020 to present (1)
20) Archives of Internal Medicine, 2004 to present (2)
21) Archives of Pathology and Laboratory Medicine, 2007 to present (1)
22) Arteriosclerosis, Thrombosis, and Vascular Biology, 2010 to present (2)
23) Autonomic Neuroscience: Basic and Clinical, 2007 to present (1)
24) BUMC Proceedings, 2012 to present (3)
25) Biochemia Medica, 2012 to present (1)
26) Biomed Central (BMC) Medical Imaging, 2010 to present (1)
27) Blood Purification, 2010 to present (2)
28) BMC Medicine, 2007 to present (1)
29) BMC Nephrology, 2011 to present (1)
30) BMJ Clinical Evidence, 2008 to present (1)
31) British Medical Journal (BMJ), 2009 to present (1)
32) Canadian Medical Association Journal (CMAJ), 2006 to present (3)
33) Cardiac Failure Review, 2015 to present (1)
34) Cardiology, 2007 to present (1)
35) Cardiorenal Medicine; 2013 to present (10)
36) Cardiovascular Innovations and Applications, 2016 to present (1)
37) Cardiovascular Therapeutics, 2010 to present (1)
38) Catheterization and Cardiovascular Interventions, 2000 to present (6)
39) Chest, 2000 to present (6)
40) Circulation, 1998 to present (100)
41) Circulation Cardiovascular Interventions, 2012 to present (1)
42) Circulation Cardiovascular Quality and Outcomes, 2010 to present (1)
43) Circulation Heart Failure, 2009 to present (4)
44) Circulation Imaging, 2012 to present (1)
45) Cleveland Clinic Journal of Medicine, 2008 to present (1)
46) Clinica Chimica Acta, 2013 (1)
47) Clinical Cardiology, 2001 (3)
48) Clinical Chemistry and Laboratory Medicine, 2010 to present (2)
49) Clinical Exercise Physiology, 2000-2002 (4)
50) Clinical Journal of the American Society of Nephrology 2008 to present (3)
51) Clinical Kidney Journal, 2012 to present (1)
52) Clinical Medicine and Research, 2008 to present (1)
53) Clinical Nephrology, 2008 to present (2)
54) Clinical Physiology and Functional Imaging, 2010 to present (1)
55) Clinical Researcher, 2002 to present (1)
56) Clinics, 2010 to present (1)
57) Cochrane Collaboration,2009 to present (2)
58) Congestive Heart Failure, 2005 to present (4)
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59) Coronary Artery Disease, 2005 to present (1)
60) Critical Care Medicine, 2008 to present (2)
61) Current Medical Research and Opinion, 2005 to present (1)
62) Diabetes Care, 2011 to present (2)
63) Diabetes and Vascular Disease Research, 2011 to present (1)
64) Diabetes, Obesity, and Metabolism, 2019 to present (1)
65) Diabetic Medicine, 2008 to present (1)
66) Drug Benefit Trends, 1999 (1)
67) Drugs, 2000 (2)
68) European Heart Journal, 1995 (12)
69) European Journal of Cardiovascular Prevention and Rehabilitation, 2006 (1)
70) European Journal of Heart Failure, 2012 (4)
71) Expert Opinion on Pharmacotherapy, 2003 to present (3)
72) Expert Opinion Therapeutic Patents, 2004 to present (1)
73) Expert Review of Cardiovascular Therapy, 2008 to present (2)
74) Global Heart, 2012 (1)
75) Heart, 2004 (2)
76) Heart and Vessels, 2007 (2)
77) Hemodialysis International 2013 (2)
78) Internal Medicine Journal (Australasia), 2009 to present (1)
79) International Journal of Infectious Diseases 2020 to present (2)
80) International Journal of Nephrology, 2010 to present (2)
81) Journal of Biomarkers, 2013 (1)
82) Journal of Geriatric Cardiology, 2017 (1)
83) International Journal of Infectious Diseases, 2021 to present (3)
84) Journal of Internal Medicine, 2009 to present (1)
85) Journal of Interventional Cardiology (JIC), 1996 to present (9)
86) Journal of the American College of Cardiology (JACC), 1998 to present (228)
87) Journal of the American College of Cardiology: Heart Failure (JACC Heart Fail), 2014 to
present (12)
88) Journal of the American College of Cardiology: Imaging (JACC Imag), 2014 to present (6)
89) Journal of the American College of Cardiology: Interventions (JACC Interv), 2010 to present
(10)
90) Journal of the American Medical Association (JAMA), 2002 to present (60)
91) Journal of the American Medical Association Cardiology (JAMA Cardiology), 2016 to present
(20)
92) Journal of the American Society of Echocardiography (JASE), 2009 to present (1)
93) Journal of the American Society of Nephrology (JASN) 2005 to present (14)
94) Journal of Cardiac Failure, 2003 to present (10)
95) Journal of Clinical Outcomes Management, 2011 to present (1)
96) Journal of Critical Care, 2011, to present (1)
97) Journal of General Internal Medicine, 2008 to present (1)
98) Journal of Human Hypertension, 2010 to present (1)
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99) Journal of Inherited Metabolic Disease, 2014 to present (2)
100)
Journal of Lipid Research, 2010 to present (1)
101)
Journal of Managed Care, 2004 to present (1)
102)
Journal of Physiology and Pathophysiology, 2009 to present (1)
103)
Kidney and High Blood Pressure Research, 2008 to present (1)
104)
Kidney International, 2004 to present (8)
105)
Medical Science Monitor, 2008 to present (1)
106)
Medicine & Science in Sports and Exercise, 2005 to present (3)
107)
Nature Clinical Practice Cardiovascular Medicine, 2004 to present (4)
108)
Nature Clinical Practice Nephrology, 2008 to present (1)
109)
Nature Reviews Nephrology, 2009 to present (3)
110)
Nephron, 2005 to present (1)
111)
Nephrology, 2009 to present (1)
112)
Nephrology, Dialysis, and Transplantation, 2005 to present (7)
113)
New England Journal of Medicine, 2006 to present (8)
114)
Pharmacological Research (Italy), 1999 (1)
115)
Pharmaceutical Sciences, 2011 (1)
116)
PLoS Medicine, 2005 (1)
117)
PLOS ONE, 2013 (1)
118)
Prehospital Emergency Care, 2015 (1)
119)
Preventive Medicine, 2008 (1)
120)
Rejuvenation Research, 2007 (1)
121)
Renal Failure, 2011 (2)
122)
The Lancet, 1999 to present (11)
123)
The Lancet Diabetes, 2013 to present (5)
124)
The Lancet Global Health, 2015 to present (2)
Major Meeting Abstract Grader
1) ACC Scientific Sessions 2001 to present (10)
2) ACC I2 Summit, 2006 to present (2)
3) American Diabetes Association, 2008 to present (13)
4) AHA Scientific Sessions, 1997 to present (8)
5) American Medical Informatics Association, Annual Symposium, 1998-2001 (3)
6) International Academy of Cardiology World Congress on Heart Disease, Academy of
Cardiology Annual Scientific Sessions—Mechanisms and Management, 2002-present (3)
7) Transcatheter Therapeutics (TCT), 2004 (1)
Grant Reviewer
1. National Medical Research Council, Singapore, 2003-2004
2. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney
Diseases, Special Emphasis Panel/Initial Review Group 2006/01 ZDK1 GRB-9, 2005
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3. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney
Diseases, Special Emphasis Review Group, 1 R01 DK070033-01A2, 2006
4. National Institutes of Health, National Heart Lung and Blood Institute, Study Section, ZHL1
CSR-H (M1), March 6-7, 2006, Heart Failure Network
5. Diabetes UK, The British Diabetic Association, Macleod House, 10 Parkway, London NW1
7AA. December 24, 2008
6. National Institutes of Health National Institute of Diabetes and Digestive and Kidney
Diseases, Special Review Panel, Chronic Renal Insufficiency Cohort Study (CRIC) and A
Prospective Cohort Study of Kidney Disease in Children (CKiD) Study, February 23-25, 2012,
March 6, 2013
7. National Institutes of Health National Institute of Diabetes and Digestive and Kidney
Diseases, Special Review Panel, ZDK1 GRB-7 (O3)S in response to PAR-DK-09-247: Ancillary
Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest
within the Mission of the NIDDK (R01), July 11, 2012
8. Alberta Innovates Health Solutions Collaborative Research & Innovation Opportunities
(CRIO) Grant Review, September, 2012
9. Health Research Board of Ireland, Health Research Awards, 2013
10. National Institutes of Health National Institute of Diabetes and Digestive and Kidney
Diseases 2017/01 ZRG1 DKUS-R (55) Study Section 2016
Guidelines Reviewer
1. Kidney Disease Improving Global Outcome (KDIGO) Guidelines Review
a. Prevention, Diagnosis, Evaluation and Treatment of Hepatitis C in Chronic Kidney
Disease, Published April, 2008
b. Diagnosis, Evaluation, Prevention and Treatment of Chronic Kidney Disease related
Mineral and Bone Disorders (CKD-MBD), Published August, 2009
c.
Acute Kidney Injury (AKI), published March, 2012
CLINICAL TRIAL AND STUDY RESPONSIBILITIES
Overall Study Responsibilities: Steering and Executive Committees
1) Study Principal Investigator, Medicine vs Angiography for Thrombolytic Exclusion Patients
(M.A.T.E.), 1994-1997, (multicenter, U.S., randomized controlled trial [RCT]). Status:
closed.
2) Study Principal Investigator, The Resource Utilization Among Congestive Heart Failure Study
(R.E.A.C.H.), 1998-2000, (single-center, prospective cohort study). Status: closed.
3) Study Principal Investigator, The Asthma, Beta-Agonists, and Congestive Heart Failure Study,
(A.B.C.H.F.), 1998-1999, (single-center, case-control study). Status: closed.
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4) Study Co-Principal Investigator, The Prevention of Radiocontrast Induced Nephropathy
Clinical Evaluation (P.R.I.N.C.E.) Study, 1995-1998, (single-center, RCT). Status: closed.
5) Study Co-Principal Investigator, BNP Multinational Study, Principal Investigator, Alan Maisel,
MD, Biosite Diagnostics, Inc., 2000-2006, (multicenter, international, prospective cohort
study). Status: closed.
6) Study Co-Investigator, Prophylactic Oral Amiodarone Compared to Placebo for Prevention
of Atrial Fibrillation Following Coronary Artery Bypass Graft Surgery (P.A.P.A.C.A.B.G.),
1996-1998, (single-center, RCT). Status: closed.
7) Study Co-Investigator, Rapid Early Bedside Markers of Myocardial Injury, 1998-1999, HFHS
and Biosite Diagnostics, Inc. (prospective cohort study). Status: closed.
8) Member, Steering Committee, Clinical Study Protocol No. 2000-025: A Phase IIIb,
Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety,
Efficacy, and Tolerability of Fenoldopam Mesylate in Subjects Undergoing Interventional
Cardiology Procedures (CONTRAST), William W. O’Neill, MD and Gregg Stone, MD, Co-
Principal Investigators, Abbott Laboratories, Inc., 2000-2003 (multicenter, US, RCT). Status:
closed.
9) Chair, National Steering Committee, Kidney Early Evaluation Program (KEEP) NKF, Member
2000-2005, Co-Chair 2005-2010, Chair 2010-present (multicenter, U.S., prospective cohort
study). Annual budget ~$1,325,198 (2009), ~$1,233,832 (2010), ~$1,614,953.00 (2011),
~$989,500 (2012), ~$1,217,000 (2013). Status: inactive.
10) Member, Steering Committee, Protocol No. 704.351 Evaluation of Synergy between
Natrecor and Furosemide on Renal and Neurohormone Responses in Chronic Heart Failure:
A Phase IV Study, Scios Inc., 2003-2005 (multicenter, U.S., randomized cross-over trial).
Status: closed.
11) Member, Steering Committee, Protocol No. CCIB002FUS12. A Multicenter, Double-blind,
Randomized, Parallel Group Study to Evaluate the Effects of Lotrel and Lotensin HCT on
Microalbuminuria in Mild to Moderate Hypertensive Subjects with Type 2 Diabetes Mellitus,
Novartis Pharmaceuticals, Inc., 2003-2006. Status: closed.
12) Rotating Executive Committee Principal Investigator Member, NIH HF-ACTION Trial (Exercise
Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart
Failure), HL63747 01A2, 2006-2009. Principal Investigator, David Whellan, MD, status:
closed.
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13) Overall Study Principal Investigator, Neutrophil Gelatinase-Associated Lipocalin: A Novel
Blood Marker for Risk of Developing Contrast Induced Nephropathy (ENCINO), multicenter,
prospective, blinded cohort study, 2006-2009, status: closed.
14) Member, Steering Committee, VA NEPHRON-D: Diabetes iN Nephropathy Study, 2008 to
2013, trial stopped early for safety cardiovascular and acute kidney safety concerns in
angiotensin converting enzyme inhibitor plus losartan arm, status: closed.
15) Member, External Expert Panel, National Institutes of Health, National Institute of Digestive
and Diabetes and Kidney Diseases, Chronic Renal Insufficiency Cohort Study, status open,
2010 to present.
16) Member, Optimal Medical Management Subcommittee, National Institutes of Health,
National Heart Lung and Blood Institute, International Study of Comparative Health
Effectiveness with Medical and Invasive Approaches (ISCHEMIA), status: open, 2011 to
present.
17) Member, Steering Committee, National Institutes of Health, National Heart Lung and Blood
Institute, International Study of Comparative Health Effectiveness with Medical and Invasive
Approaches (ISCHEMIA) in patients with Chronic Kidney Disease (ISCHEMIA-CKD), status:
open, 2012 to present.
18) Member, Steering Committee, Thrasos Innovation, Inc, A Phase II Multi-Center, Parallel-
Group, Randomized, Double Blind, Proof-of-Concept, Adaptive Study Investigating the
Safety and Efficacy of THR-184 Administered via Intravenous Infusion in Patients at
Increased Risk of Developing Cardiac Surgery Associated-Acute Kidney Injury (CSA-AKI),
status: closed, 2012 to 2015.
19) Overall Principal Investigator, AbbVie, Inc, Clinical Study Protocol M13-796, A Phase 2b,
Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of Multiple Dosing
Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High
Risk Cardiac Surgery, status: closed, 2013 to 2014.
20) Overall Principal Investigator, Bioporto, Inc, The NGAL Test™ As An Aid in the risk
assessment for AKI stage II and III in an Intensive Care Population, status: open 2017 to
present.
21) Member, Global Expert Panel, Novo Nordisk, Inc, A Research Study to See How Semaglutide
Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease
(FLOW), status: open.
Overall Study Responsibilities: Endpoint Committees
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1) Member, Critical Endpoints Committee, Treat Angina with Aggrastat and Determine Cost of
Therapy with an Invasive or Conservative Strategy, TACTICS-TIMI 18 (Protocol 019-00),
1998-2000, (multicenter, international, RCT). Status: closed
2) Member, Study Endpoints Committee, A Phase II, Escalation Trial of Vasoflux¥ in Patients
Undergoing Thrombolysis with Streptokinase for Acute Myocardial Infarction, Protocol CLN-
P-V18-07001, Parexel International Corporation,1998, (multicenter, international, RCT).
Status: closed
3) Member, Safety Endpoint Evaluation Committee, A Phase III, Single-Blind Controlled Study
to Evaluate the Clinical Effects of a Hemoglobin-based Oxygen Carrier (HBOC-210) Given as
a Transfusion Alternative in Patients Undergoing Orthopedic Surgery. (Protocol HEM-0115),
Biopure Corporation with Quintiles, Inc., Clinical Event and Adjudication Services, 2000-
2001. (multicenter, international, RCT). Status: closed
4) Member, Critical Endpoints Committee, Cerivastatin Heart Outcomes in Renal Disease:
Understanding Survival (C.H.O.R.U.S.), Barry Brenner, MD and William F. Keane, MD, Co-
Principal Investigators, Bayer Inc., 2000-2003 (multicenter, international, RCT). Status:
study terminated early due to drug withdrawal from market
5) Member, Clinical Events Classification Committee, Correction of Hemoglobin and Outcomes
in Renal Insufficiency (CHOIR), Ajay Singh, MD, Donal Reddan, MBBS, Principal Investigators,
Ortho Biotech Inc., 2001-2004 (multicenter, international, RCT). Status: closed
6) Member, Critical Endpoint Committee, A Randomised, Double-blind, Parallel Group, Phase
3, Efficacy and Safety Study of AZD6140 (Ticagrelor) Compared with Clopidogrel for
Prevention of Vascular Events in Patients with Non-ST or ST Elevation Acute Coronary
Syndromes (ACS) [PLATO – A Study of PLATelet inhibition and Patient Outcomes.],
AstraZeneca, Inc., Duke Clinical Research Institute, 2008, status: closed
7) Chair, Clinical Endpoints Committee, Alere San Diego, Inc, Alere Prospective Blinded Study
of a Novel Troponin Assay (PEARL), status: closed 2015
8) Chair, Adjudication Committee, Myeloperoxidase In the Diagnosis of Acute coronary
Syndromes (MIDAS) study, Alere, Inc., status: closed 2012
9) Independent Endpoint Adjudicator, BioPorto Diagnostics, The NGAL test as an aid for the
Diagnosis of AKI in an Intensive Care Population, Code of the Study: KLIN 12-005, status
closed, 2015
10) Independent Endpoint Adjudicator, Ischemix, Inc., Safety and Efficacy of CMX-2043 for
Protection of the Heart and Kidneys in Subjects Undergoing Coronary Angiography (CARIN),
status: closed 2016
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11) Chair, Data Adjudication Committee, Estimating versus Measuring Plasma Volume and
Kidney Function in Acute Decompensated Congestive Heart Failure, Eudra-CT Number 2018-
002638-18, Sponsor: Charite-Unversitatsmedizin Berlin, FAST Biomedical, Inc, 2018-present
Overall Study Responsibilities: Data Safety Monitoring Committees
1) Member, External Advisory Committee/Data Safety Monitoring Board, National Institutes of
Health, National Institute of Diabetes and Digestive and Kidney Diseases, Polycystic Kidney
Disease (PKD) Clinical Trials Network HALT-PKD Trial, Robert Schrier, MD, Principal
Investigator, Committee Chair: William Henrich, MD, 2004-2008, Data Safety Monitoring
Board, status: closed 2014
2) Chairman, Data Safety Monitoring Committee, Clinical Trials Program CS0011-A-U301,
Daiichi Sankyo Pharma Development (DSPD) CS-011, Seven Core Trials of Rivoglitazone in
Type 2 Diabetes: 1) A 26-week placebo-controlled trial of 1.0 and 1.5 mg rivoglitazone vs.
45 mg pioglitazone, as monotherapy in type 2 diabetics (CS0011-A-U301); 2) A 26-week
placebo-controlled trial of 0.5, 1.0 and 1.5 mg rivoglitazone vs. 15, 30 and 45 mg
pioglitazone, as monotherapy in type 2 diabetics (CS0011-A-U302); 3) A 26-week placebo-
controlled trial of 1.0 and 1.5 mg rivoglitazone vs. 45 mg pioglitazone, in type 2 diabetics on
metformin therapy, followed by a 26-week pioglitazone-controlled continuation period
(CS0011-A-U303); 4) A 26-week placebo-controlled trial of 0.5 and 1.0 rivoglitazone vs. 30
mg pioglitazone, in type 2 diabetics on sulfonylureas therapy, followed by a 26-week
pioglitazone-controlled continuation period (CS0011-A-U304); 5) A 26-week placebo-
controlled trial of 0.5 and 1.0 mg rivoglitazone vs. 15 mg pioglitazone in type 2 diabetics on
insulin therapy (CS0011-A-U305); 6) A long-term (12-24 months) randomized, general
efficacy and safety study of rivoglitazone vs. pioglitazone, as monotherapy or add-on
therapy, in type 2 diabetics (CS0011-A-U306); 7) A 26-week placebo-controlled trial of
rivoglitazone and metformin, in type 2 diabetics (CS0011-A-U307), USFDA Special Protocol
Assessment Agreement granted, status: closed, 2009 trials program terminated
3) Member, Data Safety Monitoring Committee, A Multicenter, Randomized, Double-Blind,
Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment with
Alogliptin in Addition to Standard of Care in Subjects with Type 2 Diabetes and Acute
Coronary Syndrome SYR322_402, EXAMINE Trial Takeda Global Research and Development
Center, Inc. (US) Takeda Global Research and Development Centre, Ltd. (Europe), status:
2009 trial stopped early for non-inferiority but futility on superiority outcome
4) Chair, Data Safety Monitoring Committee, Protocol D9120C00019, A randomised, double-
blind, placebo controlled, multi-centre phase IIb dose finding study to assess the effect on
GERD symptoms, safety and tolerability during four weeks treatment with AZD3355 in doses
60 mg, 120 mg, 180 mg and 240 mg bid as add-on treatment to a PPI in patients with GERD
that are partial responders to PPI treatment, AstraZeneca, status: closed 2009, trials
program terminated for safety
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5) Member, Data Safety Monitoring Committee, Protocols: AMAG-FER-IDA-301, A Phase III,
Randomized, Double-Blind, Placebo-Controlled Trial of Ferumoxytol for the Treatment of
Iron Deficiency Anemia, Protocol: AMAG-FER-IDA-302, A Phase III, Randomized, Open-Label,
Active Controlled Trial Comparing Ferumoxytol with Iron Sucrose for the Treatment of Iron
Deficiency Anemia, Protocol: AMAG-FER-IDA-303, A Phase III, Open-Label Extension, Trial of
the Safety and Efficacy of Ferumoxytol for the Episodic Treatment of Iron Deficiency
Anemia, AMAG Pharmaceuticals, Inc., status: closed 2010, trial completed in 2013 without
safety concerns
6) Chair, Independent Data Monitoring Committee, Protocol 402-C-0903 Bardoxolone Methyl
Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes: the Occurrence of
Renal Events (BEACON), Reata Pharmaceuticals, Inc., status: trial stopped in 2012 early for
cardiovascular and mortality safety concerns
7) Member, Independent Safety Council, Affymax Inc and Takeda Pharmaceutical Co.,
Omontys (peginesatide), status: closed, post-marketing surveillance led to voluntary drug
withdrawal from market in 2013 for serious and fatal allergic reactions
8) Chair, Independent Data Monitoring Committee, AbbVie, Inc, Clinical Study Protocol M11-
352 A Randomized, Multicountry, Multicenter, Double Blind, Parallel, Placebo-Controlled
Study of the Effects of Atrasentan on Renal Outcomes in Subjects with Type 2 Diabetes and
Nephropathy SONAR: Study Of Diabetic Nephropathy with Atrasentan, status closed 2018
9) Chair, Independent Data Monitoring Committee, AbbVie, Inc., Clinical Study Protocol M13-
958 A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of
Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects
Undergoing High Risk Major Surgery, status: closed 2015
10) Member, Data Monitoring Committee, Akebia Therapeutics, Inc., AKB-6548-CI-0007, Phase
2b Randomized, Double-Blind, Placebo-Controlled Study to Assess the Pharmacodynamic
Response, Safety, and Tolerability to 20 Weeks of Oral Dosing of AKB-6548 in Subjects with
Anemia Secondary to Chronic Kidney Disease (CKD), GFR Categories G3a-G5 (Stages 3, 4,
and 5) (Pre-Dialysis), status: closed 2015
11) Member, Study Monitoring Team, Akebia Therapeutics, Inc., AKB-6548-CI-0011, Phase 2a
Open-Label Study to Assess the Efficacy, Safety, and Tolerability of AKB-6548 in Subjects
with Anemia Secondary to End Stage Renal Disease (ESRD), Undergoing Chronic
Hemodialysis, status: closed 2016
12) Member, Data Monitoring Committee, Merck, Inc., Pfizer, Inc, Clinical Trials Program,
Ertugliflozin (MK-8835/PF-04971729) Phase 2 and Phase 3 Development Program, status
closed, 2012 to 2020
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13) Member, Steering Committee, Medtronic, Inc., Monitoring in Dialysis, status: closed 2016
14) Member, Data Safety and Monitoring Board, St. Jude Medical, EnligHTN IV Multi-center,
randomized, single-blind, sham controlled clinical investigation of renal denervation for
uncontrolled hypertension, status: 2013 trial terminated before recruitment started
15) Chair, Data Safety Monitoring Board, Neumedicines, Inc., A Phase 2, Single-Dose,
Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability,
Pharmacokinetics, and Pharmacodynamics of HemaMax™ (rHuIL-12) in Healthy Subjects,
status: closed 2016
16) Chair, Data Safety Monitoring Board, Reata Pharmaceuticals, Inc., A Phase 2 Study of the
Safety, Efficacy, and Pharmacodynamics of RTA 408 in the Treatment of Friedreich’s Ataxia,
2014 to 2019, status: closed
17) Chair, Data Safety Monitoring Board, Reata Pharmaceuticals, Inc., A Phase 2 Study of the
Safety, Efficacy, and Pharmacodynamics of RTA 408 in the Treatment of Mitochondrial
Myopathy, 2015 to 2019, status: closed
18) Member, Patient Safety Review Committee, Reata Pharmaceuticals, Inc, A dose-ranging
study of the efficacy and safety of Bardoxolone Methyl in patients with pulmonary arterial
hypertension (402-C-1302), 2014 to 2018, status: closed
19) Chair, Data Safety Monitoring Board, Reata Pharmaceuticals, Inc., A Study of the Efficacy
and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated
Pulmonary Arterial Hypertension (CATALYST), 2016 to present, status: closed
20) Chair, Data Safety Monitoring Board, Reata Pharmaceuticals, Inc., A Phase 2/3 of Efficacy
and Safety of Bardoxolone Methyl in Patients with Alport Syndrome (CARDINAL), 2017 to
present, status: closed
21) Chair, Data Safety Monitoring Board, Sanfit, Inc., A double-blind, randomised, placebo-
controlled study to assess the effect of SNF472 on progression of cardiovascular
calcification on top of standard of care in end-stage-renal-disease (ESRD) patients on
haemodialysis (HD) SNFCT2015-05, 2017 to 2019, status: closed
22) Chair, Data Monitoring Committee, Renew Research, KAI Research, A Randomized Pivotal
Study of RenewTM NCP-5 for the Treatment of Mild Cognitive Impairment due to
Alzheimer’s Disease or Mild Dementia of the Alzheimer’s Type, 2018 to present, status:
closed
23) Chair, Data Safety Monitoring Committee, Sanofi, Inc, Multicenter, randomized, double-
blind, placebo-controlled two stage study to characterize the efficacy, safety, tolerability
and pharmacokinetics of GZ/SAR402671 in patients at risk of rapidly progressive Autosomal
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Dominant Polycystic Kidney Disease (ADPKD) STUDY NUMBER: EFC15392 STUDY NAME:
SAVE-PKD COMPOUND: GZ/SAR402671, 2018 to present, status: open
24) Chair, Data Safety Monitoring Board, National Institutes of Health, National Heart, Lung and
Blood Institute R34 NHLBI Clinical Trial Pilot Studies (R34) Reducing Arrhythmia in Dialysis by
Adjusting the Rx Electrolytes/Ultrafiltration (RADAR), David Charytan, MD, PI, 2019 to
present, status: open
25) Chair, Data Safety Monitoring Board, GZ402671 EFC15392 Multicenter, randomized,
double-blind, placebo-controlled two stage study to characterize the efficacy, safety,
tolerability and pharmacokinetics of GZ/SAR402671 in patients at risk of rapidly progressive
Autosomal Dominant Polycystic Kidney Disease (ADPKD), Sanofi, status: open
26) Chair, Data Safety Monitoring Board, MEDI3506, Trials Portfolio, D9182C00001 A Phase 2
Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety
of MEDI3506 in Adult Subjects with Moderate-to-severe Atopic Dermatitis; D9181C00001 A
Phase II, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and
Safety of MEDI3506 in Adult Participants with Uncontrolled Moderate-to-severe Asthma;
D9180C00002 A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess the
Efficacy, Safety and Tolerability of MEDI3506 in Participants with Moderate to Severe
Chronic Obstructive Pulmonary Disease and Chronic Bronchitis (FRONTIER 4); D9183C00001
A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy
and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease, Axio Inc, A Cytel
Company, status: open
GRANT AWARDS
Original Research Grants
G1)London JF (PI), Bis KG, Juni JE, Wilke N, DiCarli MF, Shetty AN, McCullough PA, Timmis GC.
Magnetic Resonance vs. Positron Emission Tomography for the Detection of Myocardial
Viability. Bracco Diagnostics Inc./SCA&I Grant, $25,000 (WBH RC-453), 1997-98. Additional
WBH Research Institute Mini-grant, $5,000 (WBH Grant #RC-748). Level of involvement:
author of the variable definitions, endpoints, and data analysis sections, 0% FTE. Status:
closed 1998
G2)McCullough PA (PI), Shah S, Noor H, Marks KR, McCabe KB, Zong L, McCord J, Khoury N,
Ulcickas-Yood M, Ward RE. Diagnostic Accuracy of an Emergency Department Clinical
Decision Unit in the Evaluation of Chest Pain. HFHS Small Projects Fund $10,000 (HFHS
Grant #A30785), 0% FTE. Status: closed 1997
G3)Keteyian SJ (Co-PI), McCullough PA (Co-PI), Brawner CA, Rosman HS, Stein P, Weaver WD. A
Prospective Study of Case Identification and Triage of Patients Eligible for Cardiac
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Rehabilitation. Merck & Co., U.S. Human Health, $30,000 (HFHS Grant #E18037), 3% FTE.
Status: closed 1998
G4)McCullough PA. Novel Methods for Identifying High-Risk Patients for Subsequent
Cardiovascular Events. Merck & Co., U.S. Human Health, $20,000 (HFHS Grant #M1060), 0%
FTE. Status: closed 1998
G5)McCullough PA. Cardiovascular Informatics Development Award. Pfizer, Inc., $10,000
(HFHS Grant #E60022), 0% FTE. Status: closed 1998
G6)McCullough PA, Yee J, Soman S, Sallach J, Borzak S, Foreback C, Monaghan K, Tisdale JE,
Bailey E, Bola P, Chase G, Marks KR, Weaver WD. A Prospective Dose-Ranging Trial of Folic
Acid to Reduce Total Homocyst(e)ine Levels in Patients with End-Stage Renal Disease
Undergoing Hemodialysis. HFHS Project Development Fund $10,000 (HFHS Grant #A20003),
0% FTE. Status: closed 1999
G7)McCullough PA. NuStep Recumbent Cross Trainer Product Development Pilot Study,
NuStep, Inc., (single center, prospective pilot study), $12,500.00, (WBH Grant #RC- 08-
94847). Status: closed 2005
G8)McCullough PA, Secondary Analyses from the PRINCE Trial, (single center data analysis),
$20,000, PLC Medical, Inc., (WBH #RC 08-94851) Status: closed 2005
G9)McCullough PA, Sullivan RA. A Systematic Review of Vascular Calcification in Patients with
Chronic Kidney Disease and End-Stage Renal Disease, 2002-2003, Braintree Labs, Inc.,
$40,000, 25% FTE (WBH Grant #RC 08-94833) Status: closed 2003
G10)
Pasas SA, Davies MI, McCullough PA. Determination of Protein-bound Homocysteine
in Human Plasma using Capillary Electrophoresis with Electrochemical Detection in Patients
with Chronic Kidney Disease, 2003-2004, AHA Predoctoral Fellowship Program (Pasas),
$38,000, 15% FTE (UMKC Grant #). Status: closed 2003
G11)
Collins AC, Gladstone E, Robitscher JW, McCullough PA, Klag M, Narva A, Gilberston
D for the NKF. Demonstration project: state-based screening for chronic kidney disease.
Response to CDC-RFA-DP06-004, demonstration project for identifying individuals at high-
risk for CKD in the US. Centers for Disease Control, $1,199,609, 12% FTE Status: closed
2007
G12)
McCullough PA, Principal Investigator. Neutrophil Gelatinase-Associated Lipocalin
(NGAL): A Novel Blood Marker for Risk of Developing Contrast-Induced Nephropathy
(ENCINO). Biosite/Inovise, Inc., $229,000.00 (WBH #RC-94862), 0% FTE Status: closed 2009
G13)
Agrawal V, Barnes M, McCullough PA. Evaluation of CKD awareness in medical
residents. WBH intramural mini-grant R/C# 98662, $10,000.00, 0% FTE Status: closed 2008
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G14)
McCullough PA, overall Principal Investigator transferred to Zalesin K. FDA
Investigational New Drug Exemption (INDE) #060672. A Prospective, Randomized, Placebo-
Controlled, Parallel-Group, Pilot Trial of Paricalcitol in the Treatment of
Hyperparathyroidism in Patients after Roux-en-Y Gastric Bypass Surgery with Chronic Kidney
Disease, Abbott Laboratories, Inc., $496,600.00 (WBH #RC-90290), 0% FTE Status: closed
2009
G15)
McCullough PA, overall Principal Investigator transferred to Miller WM, FDA INDE
#107750. Investigator Initiated Study. A Prospective, Double-Blind, Randomized, Parallel
Group, Placebo-Controlled Trial of Aliskiren versus Placebo in Non-Diabetic, Normotensive
Obese Patients with Microalbuminuria, Novartis, Inc., $339,400.00 (WBH #RC-90345),
Status: closed 2010
G16)
McCullough PA, overall Principal Investigator. Investigator Initiated Study, FDA
Investigational New Drug (IND) #74707. A Phase 2, randomized, double-blind, placebo-
controlled trial, to assess the efficacy and safety of deferiprone in the reduction of markers
of contrast-induced acute oxidative kidney injury. Cormedix, Inc, $857,745 (includes
$101,442 for Beaumont Research Coordinating Center). Study centers included Providence
Hospital and Medical Center Southfield, St. John Hospital and Medical Center, Detroit,
Northern Michigan Hospitals, Petoskey, MI, St. Vincent’s Hospital, Indianapolis, IN, Fairfield
Cardiac Cath Labs, LLC, Fairfield, OH, Oklahoma Heart Hospital, Oklahoma City, OK, Ohio
Health Research Institute, Columbus, OH, Mercy St. Vincent Hospital, Toledo, OH, Status:
closed 2011
G17)
McCullough PA, overall study Principal Investigator, A Prospective Randomized
Parallel-Group Controlled Trial of Multiple Blood Biomarkers in the Personalized
Management of Chronic Heart Failure, Baylor IRB 014-252, Baylor Foundation, 2014,
$78,639.20, status: closed 2016.
G18)
McCullough PA, overall study Principal Investigator, Baylor Hypertrophic
Cardiomyopathy Program Development Project: Time-resolved, 3D phase contrast
magnetic resonance imaging (MRI) (4D Flow) and Advanced Strain Rate Echocardiography in
Patients with Hypertrophic Cardiomyopathy, Baylor IRB 014-175, Baylor Foundation, 2014,
$100,000.00, status: open
G19)
McCullough PA, overall study Principal Investigator, Preventive Cardiology Registry:
Role of Proprotein Convertase Subtilisin/kexin type 9 (PCSK9) and Other Catabolic
Determinants in Hypercholesterolemia in Patients with Suspected Heterozygous Familial
Hypercholesterolemia Baylor IRB 014-122, Baylor Foundation, $3,100.00, status: closed
2014
G20)
McCullough PA, overall study Principal Investigator and Study Chairman, Investigator
Initiated Trial, “A Prospective, Double-blind, Placebo Controlled, Parallel Group,
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Randomized Trial of Extended Release Exenatide versus Placebo in Diabetic Patients with
Type 4 Cardiorenal Syndrome: EXTEND-CRS”, D5551L00004/ISSEXEN0013, FDA IND 123200,
Baylor IRB 014-149, AstraZeneca, 2014, $1,597,901.93, status: open
G21)
McCullough PA, overall study Principal Investigator, Iso-osmolar Contrast and the
Timing of Coronary Angiography in the Multivariate Risk for Cardiac Surgery Associated with
Acute Kidney Injury and Major Adverse Renal and Cardiac Events (MARCE), Baylor IRB 014-
096, GE Healthcare, Inc, 2015, $145,885.00, status open
G22)
McCullough PA, overall study Principal Investigator, Timing of coronary angiography
and multivariate risk for cardiac surgery associated acute kidney injury and major adverse
renal and cardiac events (MARCE), Baylor IRB 014-096, Baylor Foundation, $8,100.00,
status: closed 2016
G23)
Mendez J, McCullough PA, et al, co-investigator, Assessment of Multiple Blood
Biomarkers in Patients with Advanced Heart Failure Undergoing Evaluation for Cardiac
Transplantation and Mechanical Circulatory Support, Baylor IRB 014-300, Critical
Diagnostics, Inc, $10,400.00, status: closed 2016
G24)
Bottiglieri, T, McCullough PA, et al, co-investigator, Urinary 11dhTxB2 response to
acetylsalicylic acid (aspirin) in cardiovascular disease progression and adverse outcomes,
Baylor IRB 008-230, Corgenix, Inc., $99,087.00, status: closed 2016
G25)
Schussler JM, Vasudevan A, McCullough PA, co-investigator, Clinical outcomes and
metabolomic and damage associated molecular patterns of acute kidney injury in patients
undergoing percutaneous coronary intervention via the radial versus femoral artery
approach, Baylor IRB 014-299, Baylor Health Care System Foundation, $61,416.00, status:
closed 2018
G26)
Tecson K, McCullough PA, coinvestigator, Contribution of Chronic Kidney Disease and
Acute Kidney Injury to Heart Failure Outcomes, Baylor IRB 015-296, Baylor Health Care
System Foundation, $43,424.60, status: open
G27)
Vasudevan A, McCullough PA, coinvestigator, Burden of Cardiovascular Events Follow
Percutaneous Coronary Intervention, Baylor IRB 015-297, Baylor Health Care System
Foundation, $40,000.00, status: closed 2018
G28)
Tecson, K, McCullough PA, Therapeutic Intensity of Lipid Lowering Therapy in
Response to Recurrent Cardiovascular Events, Baylor IRB 017-106, Amgen, Inc., $249,990.00
status: open
G29)
McCullough PA, Principal Investigator, A Case Finding Study of Familial
Chylomicronemia, Akcea Pharmaceuticals, $10,000.00, status: closed 2017
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G30)
McCullough PA, Bottiglieri T, Tecson K. Baylor Foundation $49,923.80. Identifying
metabolomic profiles among genetically confirmed familial hypercholesterolemia,
dyslipidemia without familial hypercholesterolemia, and healthy controls, status start-up
2019
Site Principal Investigator Contracts
G1)Jafri S, McCullough PA, and the WATCH Investigators. Warfarin and Antiplatelet Therapy in
Chronic Heart Failure, (W.A.T.C.H.) Field Center, Veterans Administration Cooperative
Studies Program and Sanofi Pharmaceuticals, $36,000.00 (HFHS Grant #B51008) status:
closed 2000
G2)Jafri S, McCullough PA, and the CHARM Investigators. Candesartan Cilexetil (Candesartan)
in Heart Failure Assessment of Reduction in Mortality and Morbidity (C.H.A.R.M.) Field
Center, 1999-2000, Astra Pharmaceuticals, $56,000.00 (HFHS Grant #E09045) status: closed
2000
G3)Schuger C, McCullough PA, and the MADIT Investigators. Multicenter Automatic
Defibrillator Implantation Trial II (M.A.D.I.T.-II), Guidant Corporation/Cardiac Pacemakers
(CPI), $96,000 (HFHS Grant #G10087) status: closed 2000
G4)Schuger C, McCullough PA, and the MIRACLE Investigators. Multicenter InSync Randomized
Clinical Evaluation (M.I.R.A.C.L.E.), Medtronic Inc., $195,000, (HFHS Grant #G12006) status:
closed 2000
G5)McCullough PA, Shetty A, Soman S and the CHORUS Investigators. Cerivastatin Heart
Outcomes in Renal Disease: Understanding Survival (C.H.O.R.U.S.), Barry Brenner, MD and
William F. Keane, MD, Co-Principal Investigators, Bayer Inc., 2000-2003 (RCT), Clinical Site
Contract, Bayer Pharmaceuticals, $266,875.00 10% FTE (HFHS Grant #E05046) status:
closed 2000
G6)McCullough PA, Manley HJ and the CHORUS Investigators. Cerivastatin Heart Outcomes in
Renal Disease: Understanding Survival (C.H.O.R.U.S.), Barry Brenner, MD and William F.
Keane, MD, Co-Principal Investigators, Bayer Inc., 2000-2003 (RCT), Clinical Site Contract,
Bayer Pharmaceuticals, $279,000 10% FTE (UMKC Grant #E05046) status: closed 2001
G7)Nowak R, McCord J, McCullough PA and the BNP Investigators. Breathing Not Properly
Study (B.N.P. Multinational Study), Alan Maisel, MD, and Peter A. McCullough, MD, MPH,
Co-Principal Investigators, Biosite Diagnostics, Inc., (prospective cohort study) Field Center
Contract, Biosite Diagnostics, Inc., $180,000.00 (HFHS Site), $500,000.00, 0% FTE (HFHS
Grant #E03005) status: closed 2001
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G8)Ehrman JK, McCullough PA. A Prospective Randomized Trial of a Personal Health Assistant
in the Secondary Prevention of Heart Disease. Merck, Inc., $220,961.00, 7% FTE (HFHS
Grant #E41010) status: closed 2002
G9)McCullough PA and the CORC Investigators. Kansas City Cardiomyopathy Questionnaire
Interpretability Study, John A. Spertus, MD, MPH, Principal Investigator, Cardiovascular
Outcomes Research Consortium (C.O.R.C.), 2001 (multicenter, U.S., prospective cohort
study), $21,400.00, status: closed 2002
G10)
McCullough PA, Rutherford BD, and the OAT Investigators. Occluded Artery Trial,
Judith Hochman, MD, and Gervasio Lamas, MD, Co-Principal Investigators, National
Institutes of Health, National Heart Lung and Blood Institute, $54,000.00. 0% FTE (UMKC
Grant #K531122) status: closed 2002
G11)
McCullough PA site Principal Investigator and National Executive Committee
Member. Rapid Emergency Department Heart Failure Outpatient Trial, Biosite Diagnostics,
$21,000. 0% FTE (UMKC Grant #K531130) status: closed 2002
G12)
McCullough PA site Principal Investigator. African-American Heart Failure Trial
(AHEFT). A Placebo-Controlled Trial of BiDil added to Standard Therapy in African American
Patients with Heart Failure, NitroMed, Inc., $20,000.00 (UMKC Proposal #9722, TMC Grant
#261231) status: closed 2002
G13)
McCullough PA and the IMAGING Investigators for Cardiology Clinical Studies, LLC.
Investigation of Myocardial Gated SPECT Imaging as Initial Strategy in Heart Failure: The
IMAGING in Heart Failure Trial, Dupont Pharmaceuticals Inc., $20,000.00 (UMKC Proposal
#9825, UMKC Grant #KG001278) status: closed 2002
G14)
McCullough PA, site Principal Investigator, and Ad Hoc Executive Committee
Member. Heart Failure and a Controlled Trial Investigating Outcomes of Exercise Training.
National Institutes of Health, National Heart, Lung, and Blood Institute, subcontracted
through the Duke Clinical Research Institute, $665,000, (NIH Grant #1 U01 HL63747 01A2,
WBH Grant # RC 08-94837, Site #301) status: closed 2005
G15)
McCullough PA, site Principal Investigator, and Executive Committee Member.
Protocol No. 704.351 Evaluation of Synergy between Natrecor and Furosemide on Renal
and Neurohormone Responses in Chronic Heart Failure: A Phase IV Study, Scios Inc., 2003
(multicenter, U.S., randomized cross-over trial), $105,447.50, (WBH Grant # RC 08-94836)
status: closed 2005
G16)
McCullough PA, site Principal Investigator and National Co-Principal Investigator.
Protocol No. CCIB002FUS12. A Multicenter, Double-blind, Randomized, Parallel Group
Study to Evaluate the Effects of Lotrel and Lotensin HCT on Microalbuminuria in Mild to
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Moderate Hypertensive Subjects with Type 2 Diabetes Mellitus, Novartis Inc., (multicenter,
U.S., randomized trial), $63,649.90, (WBH Grant #RC 08-94838) status: closed 2006
G17)
McCullough PA, and the ACCOMPLISH Investigators. Protocol No. CCIB002.12301.
Avoiding Cardiovascular Events through Combination Therapy in Patients Living with
Systolic Hypertension, Novartis, Inc., 2003 (multicenter, multinational, randomized trial)
$159,241.00, (WBH Grant #RC 08-94844) status: closed 2006
G18)
McCullough PA, site Principal Investigator. Efficacy of Vasopressin Antagonism in
Heart Failure: Outcome Study with Tolvaptan, Protocol #156-03-236, IND #50,533, Otsuka
Maryland Research Institute, (multicenter, international, randomized trial), $210,750.00,
(WBH Grant #RC 08-94842 changed to #RC 08-94849) status: closed 2005
G19)
McCullough PA, site Principal Investigator. A Multicenter, Double-Blind,
Randomized, Parallel Group, 6-week Study to Evaluate the Efficacy and Safety of
Ezetimibe/Simvastatin Combination versus Atorvastatin in Patients with
Hypercholesterolemia, Protocol #051/EZT544, Merck, Inc., (multicenter, U.S., randomized
trial), $18,840.00, (WBH Grant #RC 08-94843) status: closed 2006
G20)
McCullough PA, site Principal Investigator, A multicenter, double-bind randomized,
parallel-group study to compare the effect of 24 weeks treatment with LAF237 (50 mg qd or
bid) to placebo as add-on therapy in patients with type 2 diabetes inadequately controlled
with metformin monotherapy. Novartis Pharmaceuticals, Inc., (multicenter, U.S.,
randomized trial), $30,700.00, (WBH Grant #RC 08-94845) status: closed 2007
G21)
McCullough PA, site Principal Investigator. A multicenter, double-bind randomized,
parallel-group study to compare the effect of 24 weeks treatment with LAF237 (50 mg qd or
bid) to placebo as add-on therapy to pioglitazone 45 mg qd in patients with type 2 diabetes
inadequately controlled with thiazolidinediones monotherapy. Novartis Pharmaceuticals,
Inc., (multicenter, U.S., phase III randomized trial) $30,700.00, (WBH Grant #RC 08-94846)
status: closed 2006
G22)
McCullough PA, site Principal Investigator. An 8-week, randomized, double-blind,
parallel group, multicenter placebo and active controlled disease escalation study to
evaluate the safety and efficacy of aliskiren in patients with hypertension, $47,100.00 (WBH
#RC 08- 94852) status: closed 2007
G23)
McCullough PA, site Principal Investigator. A randomized, double-blind study to
compare the durability of glucose lowering and preservation of pancreatic beta-cell function
of rosiglitazone monotherapy compared to metformin or glyburide/glibenclamide in
patients with drug naïve, recently diagnosed type 2 diabetes, $140,100.00, Novartis
Pharmaceuticals (WBH #RC 08-94849) status: closed 2008
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G24)
McCullough PA, site Principal Investigator. A multicenter, randomized, double-blind
factorial study of the co-administration of MK-0431 and metformin in patients with type 2
diabetes who have inadequate glycemic control, $36,735.00, Merck Research Laboratories
(WBH #RC 08-94853) status: closed 2008
G25)
McCullough PA, site Principal Investigator. Multicenter, Randomized, Double-Blind
Study to Evaluate the Efficacy & Safety of Ezetimibe/Simvastatin and Niacin Co-
Administered in Patients with type IIa or Type IIb Hyperlipidemia, $46,960.00, Merck
Research Laboratories, MRK-091, (WBH #RC 08-94854) status: closed 2008
G26)
McCullough PA, site Principal Investigator. A Multi-Center, Randomized, Double-
Blind, factorial Design study to evaluate the lipid-altering efficacy & safety of MK-0524B
Combination Tablet in Patients with Primary Hypercholesterolemia or Mixed Hyperlipidemia
$40,849.00, Merck Research Laboratories, MRK-022. (WBH #RC 08-94855) status: closed
2007
G27)
McCullough PA, site investigator. An 8-week, multicenter, randomized, double-blind,
parallel-group study to evaluate the efficacy and safety of the combination of
valsartan/HCTZ/amlodipine compared to valsartan/HCTZ, valsartan/amlodipine, and
HCTZ/amlodipine in patients with moderate to severe hypertension, $43,500.00, Novartis
Pharmaceuticals (WBH #RC 08-94857) status: closed 2007
G28)
McCullough PA, site Principal Investigator. A multicenter randomized, double-blind
parallel arm, 6-week study to evaluate the efficacy and safety of ezetimibe/simvastatin
versus atorvastatin in patients with metabolic syndrome and hypercholesterolemia at high
risk for coronary heart disease, $32,010.00. Merck Research Laboratories (WBH #RC 08-
94861) status: closed 2008
G29)
McCullough PA, site Principal Investigator. A multicenter, randomized, double-blind
study to evaluate the safety and efficacy of the initial therapy with coadministration of
sitagliptin and pioglitazone in patients with type 2 diabetes mellitus, $24,036.00, Merck
Research Laboratories, MRK-064 (WBH #RC 08-94860) status: closed 2008
G30)
Dixon, SD, site PI, McCullough PA, Multinational Executive Committee. RENAL
GUARD Pilot Trial. PLC Medical Systems, $37,610.00 (WBH #RC- 90771) status: closed 2008
G31)
McCullough, PA, site Principal Investigator, A multi-center, randomized, double-
blind, placebo and active controlled, parallel group, dose range study to evaluate the
efficacy and safety of LCZ696 comparatively to valsartan, and to evaluate AHU377 to
placebo after 8-week treatment in patients with essential hypertension. Novartis, Inc.,
$31,965.28. (WBH #RC-94863) status: closed 2008
G32)
McCullough PA, site Principal Investigator. Paricalcitol capsules benefits in renal
failure induced cardiac morbidity in subjects with chronic kidney disease stage 3b/4,
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(PRIMO Abbott Laboratories, ABT-M-10-030, $157,992.00, (WBH #RC-94864) status: closed
2008
G33)
McCullough PA, site Principal Investigator. A randomized, double-blind, parallel
group study to evaluate the effects of high-dose statin therapy on fluorodeoxyglucose (FDG)
uptake in arteries of patients with atherosclerotic vascular disease. Merck Research
Laboratories, MRK-081, $86,994.00 (WBH #RC 08-90223) status: closed 2008
G34)
McCullough PA, site Principal Investigator. Patient registry for the Liposorber LA-15
system. Kaneka, Inc., $7,515.00, (WBH #RC-90877) status: closed 2009
G35)
McCullough PA, site Principal Investigator. A 30-week multicenter, randomized,
double-blind. Parallel-group study of the combination of ABT-335 and Rosuvastatin
compared to rosuvastatin monotherapy in dyslipidemic subjects with stage 3 chronic kidney
disease, Abbott M10-313, $128,544.00, (WBH #RC-90212) status: closed 2009
G36)
McCullough PA, site Principal Investigator. A multicenter, randomized open label,
active-comparator controlled study to assess the efficacy, safety, and tolerability of
taspoglutide compared to exenatide in patients with type 2 diabetes mellitus inadequately
controlled with metformin, thiazolidinedione, or a combination of both, Roche BC 21625,
$72,012.50, (WBC #RC-90245) status: closed 2010
G37)
McCullough PA, site Principal Investigator. A multicenter, randomized double-blind,
placebo-controlled study to assess the efficacy, safety, and tolerability of taspoglutide
compared to placebo in obese patients with type 2 diabetes mellitus inadequately
controlled with metformin monotherapy, Roche BC 22092, $38,387.50, (WBH #RC-90258)
status: closed 2009
G38)
McCullough PA, site Principal Investigator. A safety and efficacy trial evaluating the
use of apixaban for the extended treatment of deep vein thrombosis and pulmonary
embolism, Bristol Myers Squibb-Pfizer CV185057, $173,750.00, (WBH #RC-90288) status:
closed 2009
G39)
McCullough PA, site Principal Investigator. A phase 3, active (warfarin) controlled,
randomized, double-blind, parallel arm study to evaluate efficacy and safety of apixaban in
preventing stroke and systemic embolism in subjects with nonvalvular atrial fibrillation,
Bristol Myers Squibb-Pfizer CV1805030, $173,750.00, (WBH #RC-90275) status: 2009
G40)
McCullough PA, site Principal Investigator. Treatment of Preserved Cardiac Function
Heart Failure with an Aldosterone Antagonist Trial (TOPCAT), National Institutes of Health,
National Heart, Lung, and Blood Institute, subcontracted through the New England
Research Institutes, Inc., $86,250.00, (WBH #RC-90267) status: closed 2010
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G41)
McCullough PA, site Principal Investigator. An 8-week, randomized, double-blind,
parallel group, multicenter, forced titration study to evaluate the efficacy and safety of
aliskiren plus HCTZ verus aliskiren monotherapy in metabolic syndrome patients with stage
2 hypertension, Novartis, Inc., $107,362.44 (WBH #RC-90277) status: closed 2009
G42)
McCullough PA, site Principal Investigator, Astute SAPPHIRE AST-111, Evaluation of
Novel Biomarkers from Acutely Ill Patients at Risk for Acute Kidney Injury, Astute Medical,
Inc, San Diego, CA, $23,195.50 status: closed 2012
G43)
McCullough PA, site Principal Investigator, protocol number 156-10-292 titled “An
Observational Prospective Registry to Identify Demographic and Clinical Characteristics of
Patients Hospitalized with Euvolemic and Hypervolemic Hyponatremia and Assess the
Comparative Effectiveness of Available Treatments and the Impact on Resource Utilization.
Otsuka Inc., $21,262.60 status: initial contract fulfilled, reopened under extension and
registry completed in 2013
G44)
McCullough PA, site Principal Investigator, PROspective Multicenter Imaging Study
for Evaluation of Chest Pain (PROMISE) Study, National Heart, Lung, and Blood Institute
(NHLBI), Pamela Douglas, MD, Principal Investigator Clinical Coordinating Center, Duke
Clinical Research Institute, $17,000.00 status: closed 2012
G45)
McCullough PA, site Principal Investigator, ACZ885M/Canakinumab Clinical Trial
Protocol CACZ885M2301 A randomized, double-blind, placebo-controlled, event-driven trial
of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular
events among stable post-myocardial infarction patients with elevated hsCRP. Novartis,
Inc., 2011 $279,223.00 status: closed 2015
G46)
McCullough PA, site Principal Investigator, AN-CVD2233 Evaluation of the Safety and
Efficacy of Short-term A-002 (Varespladib) Treatment in Subjects with Acute Coronary
Syndromes (VISTA-16) Anthera Pharmaceuticals, Inc., 2011 $72,600.00 status: closed 2011
G47)
McCullough PA, site Principal Investigator, BC22140A Cardiovascular outcomes study
to evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with a
recent acute coronary syndrome (ACS) event and type 2 diabetes mellitus (T2D), F.
Hoffmann-La Roche Ltd, $307,500.00 status: closed 2012
G48)
McCullough PA, site Principal Investigator, A Double-blind, Randomized, Placebo-
controlled, Multicenter Study (Phase 2) to Evaluate the Safety and Efficacy of IV Infusion
Treatment with Omecamtiv Mecarbil in Subjects with Left Ventricular Systolic Dysfunction
Hospitalized for Acute Heart Failure (Protocol 20100754), Amgen, Inc, 253,464.00 status:
closed 2012
G49)
McCullough PA, site Principal Investigator, MB102-073 A Multicenter, Randomized,
Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and
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Efficacy of Dapagliflozin in Subjects with Type 2 Diabetes with Inadequately Controlled
Hypertension on an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin
Receptor Blocker (ARB), Bristol-Myers Squibb Research and Development, 2011 $34,115.00
status: closed 2012
G50)
McCullough PA, site Principal Investigator, MB102-077 A Multicenter, Randomized,
Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and
Efficacy of Dapagliflozin in Subjects with Type 2 Diabetes with inadequately controlled
hypertension treated with an Angiotensin-Converting Enzyme Inhibitor (ACEI) or
Angiotensin Receptor Blocker (ARB) and an additional Antihypertensive medication, Bristol-
Myers Squibb Research and Development, $34,115.00 status: closed 2011
G51)
McCullough PA, site Principal Investigator, ABT M11350 RADAR: Reducing Residual
Albuminuria in Subjects with Diabetes and Nephropathy with AtRasentan – A Phase 2b,
Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Safety and
Efficacy, Abbott Laboratories, $188,377.00 status: closed 2012
G52)
McCullough PA, site Principal Investigator, PEGASUS TIMI 54 trial, A Randomized,
Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the
Prevention of Thrombotic Events with Ticagrelor Compared to Placebo on a Background of
Acetyl Salicylic Acid (ASA) Therapy in Patients with History of Myocardial Infarction,
AstraZeneca, 2011 $98,530.00 status: transferred to PI Marcel Zughaib, MD
G53)
McCullough PA, site Principal Investigator, A Double-blind, Randomized, Placebo-
controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction
on Major Cardiovascular Events When AMG 145 is Used in Combination with Statin Therapy
in Patients with Clinically Evident Cardiovascular Disease AMG 145 Amgen Protocol Number
20110118 EudraCT number 2012-001398-97, Amgen, Inc., $1,732,062.80 status: closed
2016
G54)
McCullough PA, site Principal Investigator, A single-blind, multi-site trial of the
dietary supplement anatabine (RCP006) to determine the effects on peripheral markers of
inflammation in patients with elevated levels of C-reactive protein (CRP). Roskamp Institute
Protocol Number RI-11-01, $6700.00 status: closed 2012
G55)
McCullough PA, site Principal Investigator, Long-term safety and tolerability of
REGN727/SAR236553 in high cardiovascular risk patients with hypercholesterolemia not
adequately controlled with their lipid modifying therapy: a randomized, double-blind,
placebo-controlled study LTS11717 Sanofi Aventis, $252,000.00 status: closed 2013
G56)
McCullough PA, site Principal Investigator, Assessment of Clinical Effects of
Cholesteryl Ester Transfer Protein Inhibition with Evacetrapib in Patients at a High Risk for
Vascular Outcomes – the ACCELERATE Study, protocol I1V-MC-EIAN, Eli Lilly, $421,202.00
status: closed 2014
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G57)
McCullough PA, site Principal Investigator, AEGR-733-025, LOWER: Lomitapide
Observational Worldwide Evaluation Registry, Aegerion, Inc., 2014, $23,478.00 status: open
G58)
McCullough PA, site Principal Investigator, The Evaluation Of PF-04950615 (RN316),
In Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects (SPIRE-1),
Pfizer, Inc., $145,343.90 status: closed 2016
G59)
McCullough PA, site Principal Investigator, The Evaluation Of PF-04950615 (RN316)
In Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects (SPIRE-2),
Pfizer, Inc., $145,343.90 status: closed 2016
G60)
McCullough PA, site Principal Investigator, Long Term Observational Study in Patients
with Homozygous Familial Hypercholesterolemia Treated with Kynamaro™, Genzyme-
Sanofi, Inc., $61,260.00 status: closed 2018
G61)
McCullough PA, site Principal Investigator, CUP14366, Alirocumab (SAR236553)
Expanded Access Program for the Treatment of Severe Hypercholesteremia Not Controlled
with Maximal Tolerated Dose of Lipid Lowering Therapy Administered According to
Standard of Care, Sanofi-Regeneron, Inc., 2015 $8,500.00 status: closed 2015
G62)
McCullough PA, site Principal Investigator, Aspirin Dosing: A Patient-Centric Trial
Assessing Benefits and Long-term Effectiveness (ADAPTABLE), Patient-Centered Outcomes
Research Institute, 2015 $29,400.00 status: open
G63)
McCullough PA, site Principal Investigator, Assessment of Heart Failure using
Condition-Specific Impact Assessments (PROMIS), Patient-Centered Outcomes Research
Institute, 2015 $81,840.00 status: 2017 status: closed
G64)
McCullough PA, site Principal Investigator, A Randomized Parallel-Group, Placebo-
Controlled, Double-Blind, Event-Driven, Multi-Center Pivotal Phase III Clinical Outcome Trial
of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure
With Reduced Ejection Fraction (HFrEF) - VerICiguaT Global Study in Subjects With Heart
Failure With Reduced Ejection Fraction (VICTORIA), Merck, Inc, 2017 $878,163.90 status:
closed
G65)
McCullough PA, site Principal Investigator, A phase III randomised, double-blind trial
to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in
patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF), EMPEROR-
PRESERVED, Boehringer-Ingleheim, 2017 $170,099.00, status: open
G66)
McCullough PA, site Principal Investigator, A phase III randomised, double-blind trial
to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in
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patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF), EMPEROR-
REDUCED, Boehringer-Ingleheim, 2017 $170,099.00, status: open
G67)
Schiffmann R, McCullough PA Sub-Investigator, 014-097 PB-102-F03 (Sponsor -
Protalix - PRX-102 1mg/kg q 2 weeks) A Multi Center Extension Study of PRX-102
Administered by Intravenous Infusions Every 2 Weeks for 60 Months to Adult Fabry
Patients, status: open
G68)
Schiffmann R, McCullough PA Sub-Investigator, 014-288 AT1001-042 (Sponsor -
Amicus - oral drug - chaperone) An Open-Label Extension Study to Evaluate the Long-Term
Safety and Efficacy of Migalastat Hydrochloride Monotherapy in Subjects with Fabry
Disease, status: closed.
G69)
Schiffmann R, McCullough PA Sub-Investigator, 016-153 PB-102-F20 (Sponsor -
Protalix - BLINDED - ERT PRX-102 or Fabrazyme 1mg/kg q 2 weeks) A Randomized, Double
blind, Active Control Study of the Safety and Efficacy of PRX-102 compared to Agalsidase
Beta on Renal Function in Patients with Fabry Disease Previously Treated with Agalsidase
Beta – Study Number PB-102-F20, status: open
G70)
Schiffmann R, McCullough PA Sub-Investigator, 017-189 PB-102-F50 (Sponsor -
Protalix - PRX-102 infusion - 2mg/kg monthly) A Phase 3, Open Label, Switch Over Study to
Assess the Safety, Efficacy and Pharmacokinetics of pengunigalsidase alfa (PRX-102) 2 mg/kg
Administered by Intravenous Infusion Every 4 Weeks for 52 weeks in Patients with Fabry
Disease Currently Treated with Enzyme Replacement Therapy: Fabrazyme® (agalsidase
beta) or Replagal (agalsidase alfa), status: open
G71)
Schiffmann R, McCullough PA 018-150 MODIFY (Sponsor - Idorsia - oral drug -
substrate reduction) A multicenter, double-blind, randomized, placebo controlled, parallel-
group study to determine the efficacy and safety of lucerastat oral monotherapy in adult
subjects with Fabry disease, status: open
G72)
McCullough PA, site Principal Investigator, A Randomized, Double-blind, Placebo-
controlled, Parallel-group Multicenter Study to Evaluate the Effects of Sotagliflozin on
Clinical Outcomes in Hemodynamically Stable Patients with Type 2 Diabetes Post Worsening
Heart Failure (SAR 439954), Sanofi US Services, Inc, $214,600.00, 2019, status: open
G73)
McCullough PA, site Sub-Investigator, A Randomized, Double-blind, Placebo-
controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Alirocumab in
Patients with Homozygous Familial Hypercholesterolemia (R727-CL-1628), Regeneron
Pharmaceuticals, Inc, $143,503.00, 2019, status: closed
G74)
McCullough PA, site Sub-Investigator, A Randomized, Double-Blind, Placebo-
Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Evinacumab in
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Patients with Homozygous Familial Hypercholesterolemia (R1500-CL-1629) Regeneron
Pharmaceuticals, Inc, $143,503.00, 2019, status: closed
G75)
McCullough PA, site Sub-Investigator, An Open-Label Study to Evaluate the Long-
Term Efficacy and Safety of Evinacumab in Patients with Homozygous Familial
Hypercholesterolemia (R1500-CL-1719) Regeneron Pharmaceuticals, Inc, $65,317.44, 2019,
status: open
G76)
Bottiglieri T, Tecson K, McCullough PA, Identifying metabolomic profiles among
genetically confirmed familial hypercholesterolemia, dyslipidemia without familial
hypercholesterolemia, and healthy controls, Baylor Health Care System Foundation,
$49,293.80, 2020 status: open
G77)
McCullough PA, Wheelan KE. BSWRI—Overall Principal Investigator, 001 A
prospective clinical study of hydroxychloroquine in the prevention of SARS-COV-2 (COVID-
19) infection in health care workers after high-risk exposures, FDA IND 149293, Baylor
Health Care System Foundation, $506,506.00, 2020 status: open
G78)
McCullough PA, Site Investigator, 4D-310-C001 entitled “An Open-label, Phase 1/2
Trial of Gene Therapy 4D-310 in Adult Males with Fabry Disease” 4D Molecular
Therapeutics, Inc, $101,210.85, 2020 status: open
G79)
McCullough PA, Site Investigator, TQJ230, Assessing the Impact of Lipoprotein (a)
Lowering With TQJ230 on Major Cardiovascular Events in Patients With CVD
(Lp(a)HORIZON) Novartis Pharmaceuticals Corporation, $3,475,000.00, 2020 status open
Published Abstracts
A1)
McCullough PA, O'Neill WW, May M, Lichtenberg A, Strzelecki M, Grines CG, Safian RD.
Predictors of Acute Complications after Percutaneous Coronary Revascularization with New
Devices. J Am Coll Cardiol 1994; 122-123A [oral].
A2)
McCullough PA, O'Neill WW, Hoffman M, Glazier S, Safian RD. The "Protective Effect" of
Restenosis Lesions on Angiographic Complications with New Devices. Circulation 1995;92:I-346
[poster].
A3)
McCullough PA, Wolyn R, Rocher LL, Levin RN, O'Neill, WW. Acute Contrast Nephropathy
After Coronary Intervention: Prediction of Dialysis and Related Mortality in the Elderly.
American Journal of Geriatric Cardiology 1996;5:52 [poster].
A4)
McCullough PA, Wolyn R, Rocher LL, Levin RN, O'Neill WW. Acute Contrast Nephropathy
After Coronary Intervention: Incidence, Risk Factors, and Relationship to Mortality. J Am Coll
Cardiol 1996;304-305A [oral].
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A5)
McCullough PA, Ayad O, Goldstein JA. Cost-Effectiveness Analysis of Patients Admitted with
Chest Pain and Normal or Near-Normal Electrocardiograms. Cathet Cardiovasc Diag
1996;38:118 [poster].
A6)
Aliabadi D, McCullough PA, Kaplan B, Grines CL, Safian RD, Pica M, O’Neill WW, Goldstein JA.
A Novel Mobile Fluoroscopic Imaging System for Rapid Bedside Coronary Angiography. Cathet
Cardiovasc Diag 1996;38:111 [oral].
A7)
Thompson RJ, McCullough PA, Kahn JK, O’Neill WW. Early Prediction of Death and
Neurologic Outcome in Out-of-Hospital Sudden Death Survivors in the Emergency Department.
Circulation 1996;94:I-356 [poster].
A8)
McCullough PA, O’Neill WW, Graham M, David S, Stomel R, Rogers F, Grines CL. A
Prospective Randomized Trial of Triage Angiography in Suspected Acute Myocardial Infarction
Patients Who are Considered Ineligible for Reperfusion Therapy. Circulation 1996;94:I-570
[oral].
A9)
Aliabadi D, McCullough PA, Grines CL, Safian RD, Pica MC, O’Neill WW, Goldstein JA. A
Novel Mobile Fluoroscopic Imaging System for Rapid Bedside Coronary Angiography. J Am Coll
Cardiol 1997;450A [poster].
A10)
McCullough PA, O’Neill WW, Graham M, David S, Stomel R, Rogers F, Farhat A, Kazlauskaite
R, Grines CL. Late Outcomes in the Medicine vs. Angiography for Thrombolytic Exclusion (MATE)
Study. Circulation, 1997;96:I-595-596 [oral].
A11)
Redle JD, West AJ, Khurana S, Marzan R, McCullough PA, Frumin HI. Prophylactic Oral
Amiodarone with Beta Blockade has Favorable Effects on Atrial Fibrillation Post Coronary Bypass
Surgery. Circulation, 1997;96:I-125 [poster].
A12)
Sharma ND, Gandhi RS, Philbin EF, Weaver WD, McCullough PA. Which Patients with Left
Ventricular Dysfunction Require Chronic Anticoagulation? A Prospective Analysis. J Am Coll
Cardiol 1998;31:33A. [poster].
A13)
McCullough PA, Tobin KJ, Kahn JK, O’Neill WW, Thompson RJ. Prediction of In-hospital
Survival after Sudden Cardiac Death: Derivation and Validation of a Clinical Model. J Am Coll
Cardiol 1998;31:485A [poster].
A14)
Stevens M, McCullough PA, Tobin KJ, Speck JP, Westveer DC, Guido-Allen DA, Hartenburg
DS, Puchrowicz-Ochocki SB, O’Neill WW. A Randomized Trial of Prevention Measures in Patients
at High Risk for Contrast Nephropathy: Initial Results of the PRINCE Study. J Am Coll Cardiol
1998;31:469A [poster].
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A15)
Tobin KJ, McCullough PA, Speck JP, Westveer DC, Guido-Allen DA, Hartenburg DS,
Puchrowicz-Ochocki SB, O’Neill WW, Stevens M. What Role Does Mannitol Play in Preventing
Contrast Nephropathy? A Prospective Analysis. J Am Coll Cardiol 1998;31:469A [poster].
A16)
McCullough PA, Al-Zagoum M, Graham M, David S, Stomel R, Rogers F, Farhat A,
Kazlauskaite R, Grines CL, O’Neill WW. A Time to Treatment Analysis in the Medicine vs.
Angiography for Thrombolytic Exclusion Trial. Cathet Cardiovasc Diag 1998;44:105 [oral].
A17)
McCullough PA, Al-Zagoum M, O’Neill WW, Graham M, David S, Stomel R, Rogers F, Farhat
A, Kazlauskaite R, Grines CL. A Program of Triage Angiography in Acute Coronary Syndromes
Ineligible for Thrombolysis: An Efficacy Analysis. Cathet Cardiovasc Diag 1998;44:105[poster].
A18)
Philbin EF, McCullough PA, Polanczyk CA, Jenkins PL, DiSalvo TG. Are Subjects in Heart
Failure Trials Similar in Clinical Practice? Circulation, 1998;98:I-866 [moderated poster].
A19)
McCullough PA, Smith S, Borzak S. Understanding the Risks Associated with Baseline Renal
Function in the Coronary Care Unit. Circulation, 1998;98:I-413 [poster].
A20)
Afzal A, Gunda M, Brawner CA, Havstad S, McCullough PA, Keteyian SJ. Race and the Rate of
Referral to Cardiac Rehabilitation. Circulation, 1998;98:I-810-811 [poster].
A21)
Borzak S, Every NR, Jankowski M, Havstad S, Chase GA, McCullough PA, Elston-Lafata J,
Weaver WD. Elderly Patients with Unstable Angina Have Ongoing Risk for Future Events.
Circulation, 1998;98:I-629 [oral].
A22)
Borzak S, Every NR, Chase GA, Jankowski M, Havstad S, McCullough PA, Elston-Lafata J,
Weaver WD. U.S. Regional Differences in Use of Revascularization for Unstable Angina Patients.
Circulation, 1998;98:I-275 [oral].
A23)
McCullough PA, Newman M, Kaiser Carlson L, Flower J, Tuchfield B. Accelerating the
Improvement in Community Cardiovascular Health Using Web-Enhanced Project Development.
J Am Coll Cardiol 1999;33:7A [info@ACC].
A24)
Mehra P, Pasnoori V, Sengstock D, Obaidat O, Brawner CA, Keteyian SJ, Philbin EF,
McCullough PA. The Effect of Reactive Airways Disease on Peak Oxygen Consumption in
Congestive Heart Failure. J Am Coll Cardiol 1999;33:172A [poster].
A25)
McCullough PA, Cingireddy U, Philbin EF, Weaver WD. Evidence for a Heart Failure
Epidemic: Findings from the REACH Study. J Am Coll Cardiol 1999;33:179A [poster].
A26)
McCullough PA, Cingireddy U, Philbin EF, Weaver WD. Secular Trends in the Management of
Congestive Heart Failure by Primary Care Physicians and Cardiovascular Specialists. J Am Coll
Cardiol 1999;33:247A [poster]
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A27)
Hassan SA, Borzak S, Philbin EF, Soman S, Shah S, Weaver WD, Yee J, Marks KR, McCullough
PA. The Impact Chronic Renal Insufficiency on Heart Failure Mortality after Hospitalization.
Journal of Cardiac Failure 1999;5 Suppl 1:70. [poster].
A28)
Sengstock D, Obaidat O, Pasnoori V, Mehra P, McCullough PA. Asthma, Chronic Beta-Agonist
Use, and the Development of Dilated Cardiomyopathy: Primary Results from the ABCHF Study.
Journal of Cardiac Failure 1999;5 Suppl 1:64. [moderated poster].
A29)
McCullough PA, Kuntz RE, Marks KR, Popma JJ. Should We Change from Aspirin and
Ticlopidine to Aspirin and Clopidogrel after Routine Coronary Stenting? A Population-Based
Decision Analysis. Circulation 1999;100:I-379.[oral].
A30)
McCullough PA, Prakash R, Tobin KJ, O'Neill WW, Thompson RJ. Application of a Cardiac
Arrest Score in Patients with Sudden Death and ST Segment Elevation for Triage Angiography
and Intervention. Fighting Sudden Cardiac Death: A Worldwide Challenge, 1999;18:T-2.
A31)
McCullough PA, Philbin EF, Czerska B, Spertus JA, Weaver WD. Population-based
Medication Profiling in Heart Failure: Treatment Related Outcomes from the R.E.A.C.H. Study. J
Am Coll Cardiol 2000; 35:542A [moderated poster].
A32)
McCullough PA, Philbin EF, Czerska B, Spertus JA, Weaver WD. The Diagnostic Evaluation of
Newly Discovered Heart Failure: Opportunities for Improvement from the R.E.A.C.H. Study. J
Am Coll Cardiol 2000;35:327A [poster].
A33)
Shah SS, Tokarski GF, McCord JK, Khoury NE, McCabe KB, Morlock RJ, Noor H, McCullough
PA. Impact of an Emergency Department Cardiac Clinical Decision Unit on a Population of
Patients with Episodic Chest Discomfort. J Am Coll Cardiol 2000;35:380A [poster].
A34)
Kadakia RA, McCullough PA, Soman S, Jankowski M, Borzak S, Keeley EC. Does Percutaneous
Revascularization Confer a Long-Term Survival Benefit in Patients with Acute Renal Failure? J Inv
Cardiol 2000;12(11):P1.
A35)
McCullough PA, Philbin EF, Spertus JA, Weaver WD. Gender Differences in the Diagnostic
Evaluation of Heart Failure: Findings from the R.E.A.C.H. Study. J Inv Cardiol 2000;12(11):P23.
A36)
Pampati V, Shenkman HJ, McKinnon JE, Khandelwal AK, Nori DM, McCullough PA. The
Significance of QRS Prolongation in Heart Failure: Findings from the CONQUEST Study.
Chest2000;118(4):133S.
A37)
Hassan SA, Bhatt S, Borzak S, Pallekonda V, Soman SS, Yee J, Marks K, McCullough PA.
Clinical and Echocardiographic Determinants of Congestive Heart Failure with Renal
Dysfunction.Chest2000;118(4):134S.
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A38)
Soman SS, Vera E, Jaffery H, Singh S, Marks KR, Borzak S, McCullough PA. Impact of Age and
Admission Hemoglobin on Coronary Care Unit Mortality. Chest 2000; 118(4):166S.
A39)
Soman SS, Shah S, Marks KR, Yee J, Borzak S, McCullough PA. The Independent Association
of Renal Dysfunction and Arrhythmias in the Intensive Care Unit Setting. Chest
2000;118(4):171172S.
A40)
Sallach JA, Soman SS, Sallach SM, Yee J, Karriem V, Hoffman RM, McCullough PA.
“Homocysteine Flux”: An Opportunity to Modify Cardiovascular Risk in Hemodialysis
Patients.Chest2000;118(4):218S.
A41)
McKinnon JE, Khandelwal AK, Shenkman HJ, Pampati V, Nori DM, McCullough PA.
Congestive Heart Failure and QRS Duration: Utilization in Establishing Prognosis in Systolic and
Diastolic Dysfunction—Results of the CONQUEST Study. Chest 2000; 118(4):221S.
A42)
Kadakia RA, Bonifacio DL, Mikhail B, Clark VL, McCullough PA. Survival Following Coronary
Intervention in Patients with End Stage Renal Disease. Chest 2000; 118(4):226-227S.
A43)
Hassan S, Nori D, Bhatt S, Borzak S, Philbin E, Weaver WD, Soman S, Shah S, McCullough PA.
Impact of Bundle Branch Block (BBB) Pattern on EKG on Survival in Patients with Congestive
Heart Failure (CHF), an Eight Year Follow-up Study. Journal of Heart Failure 2000;6(1):65 [A258].
A44)
Soman SS, Sallach J, Sallach S, McCullough PA, Karriem V, Hoffman R, Yee J. Homocysteine
(tHcy) Removal by Hemodialysis (HD) Modifies Cardiovascular Disease (CVD) Risk in ESRD.
American Society of Nephrology 2000 [A0887].
A45)
McCord JK, Nowak R, McCullough PA, Borzak S, Tokarski G, Tomlanovich M, Foreback C,
Malki Q, Asfour A, Weaver WD. Very Rapid Rule-out: 90 Minute Exclusion of Acute Myocardial
Infarction (AMI) with Troponin-I (cTnI) and Myoglobin (Myo). Circulation 2000;102(18): II497.
A46)
Shenkman HJ, McKinnon JE, Khandelwal AK, Pampati V, Nori DM, McCullough PA.
Determinants of QRS Prolongation in a Generalized Heart Failure Population: Findings from the
Conquest Study. Circulation 2000;102(18): II617.
A47)
Philbin EF, McCullough PA, Di Salvo TG, Dec W, Jenkins PL, Weaver WD. Socioeconomic
Status is an Important Determinant of Use of Invasive Strategies after Myocardial Infarction in
Hospitals with Cardiac Surgery. Circulation 2000;102(18): II840.
A48)
McCullough PA, Sandberg KR, Borzak S, Hudson MP, Garg M, Manley HJ. Use of Aspirin and
thrombolysis for myocardial infarction in patients with chronic renal disease: An opportunity for
quality improvement, AHA Conference on Quality of Care and Outcomes P93, Circulation 2001.
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A49)
Ketterer MW, Goldberg AD, McCullough PA, Patel S, Farha AJ, Clark V, Keteyian S, Dennollet
J, Chapp J, Thayer B, Deveshwar S. Psychosocial Correlates of Early Ischemic Heart Disease
(IHD): Preliminary Results. Psychosomatic Medicine 2001;63:172-173.
A50)
Fitzgerald FE, Thayer BL, Ehrman JK, Keteyian S, Jarvis R, McCullough PA. A Hospital
Employee Cholesterol Challenge Using Spreads Containing Plant Sterol Esters to Help Reduce
Total and LDL-Cholesterol. American Diabetes Association 2001 [p000].
A51)
McCullough PA, Garg M, Bonifacio DL, Malineni K, Kadakia RR, Soman SS, Sandberg KR.
Relationship between Lipid Levels and Advanced Coronary Calcification in End Stage Renal
Disease. Central Society for Clinical Research Combined Annual Meeting, 2001 [P78] Journal of
Investigative Medicine 2001;49:284A.
A52)
McCullough PA, Hudson MP, Garg M, Borzak S. Benefits of Aspirin and Beta-Blockade after
Myocardial Infarction in Patients with Advanced Renal Dysfunction. Central Society for Clinical
Research Combined Annual Meeting, 2001 [P79] Journal of Investigative Medicine
2001;49:285A.
A53)
Hannen MN, McCullough PA, Garg M, Quick AM. Tricuspid Valve Endocarditis in a Patient
with Negative Blood Cultures and Right Atrial Mass. Central Society for Clinical Research
Combined Annual Meeting, 2001 [P96] Journal of Investigative Medicine 2001;49:287A.
A54)
McCullough PA, Garg M, Borzak S, Hudson MP. Outcomes after Myocardial Infarction in
Patients with Advanced Renal Disease Treated with Aspirin ĂŶĚɴ-Blockade. CHEST
2001;120(4):145S.
A55)
McCullough PA, Garg M, Borzak S, Hudson MP. Benefits of Aspirin and Beta-Blockade after
Myocardial Infarction in Patients with Chronic Renal Disease. Circulation 2001;104 (17):II-234.
A56)
Manhapra A, Jacobsen G, Havstad S, McCullough P, Hudson MP, Weaver WD, Borzak S.
Improved Long Term Survival with Beta Blocker Therapy Among African Americans and
Caucasians with Myocardial Infarction. Circulation 2001;104 (17):II-627.
A57)
Manhapra A, Jacobsen G, Havstad S, McCullough P, Hudson MP, Weaver WD, Borzak S.
Racial Differences in Long Term Survival following an Acute Myocardial Infarction. Circulation
2001;104 (17):II-778.
A58)
Brown WW, Bakris GL, Collins A, Flack JM, Gannon M, Greene E, Grimm R, Keane WF, Klag
M, McCullough P, Politoski G. Identification of Individuals at High Risk (HR) for Kidney Disease
(KD) via Targeted Screening. International Society of Hypertension in Blacks 2001 Meeting, Las
Vegas, July 8-12, 200, Plenary Presentation and Poster. Ethnicity & Disease 2001; 11 (2): 358.
A59)
Brown WW, Bakris GL, Chen S, Collins A, Davis J, Flack JM, Gannon M, Greene E, Grimm R,
Keane WF, Klag MJ, McCullough PA, Politoski G, Tran A. St. Louis VAMC/St. Louis University,
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Rush Presbyterian, Minneapolis Medical Research Foundation, NKF, Wayne State University,
Mayo Clinic, Hennepin County Medical Center, Johns Hopkins Medical Institutions, UMKC.
Targeted Screenings Identify Persons at Risk for Kidney Disease (KD). Poster, ASN/ISN
International Congress of Nephrology, San Francisco, October 13-17, 2001. J of the Am Soc of
Nephrol 2201; 12: A1003.
A60)
Maisel AS, Hlavin P, McCord J, Nowak RM, Hollander JE, Duc P, Steg G, Omland T, Westheim
A, Abraham WT, Storrow AB, McKay CA, Wu AH, McCullough PA, for the BNP Multinational
Study Investigators. B-Type Natriuretic Peptide in the Emergency Diagnosis of Diastolic
Dysfunction Heart Failure. J Am Coll Cardiol 2002;39:140A.
A61)
McCullough PA, Nowak RM, McCord J, Hollander JE, Steg G, Duc P, Westheim A, Omland T,
Storrow AB, Abraham WT, Wu AH, Clopton P, Lenert L, Maisel AS, for the BNP Multinational
Study Investigators. B-Type Natriuretic Peptide Adds to Clinical Judgment in the Diagnosis of
Heart Failure: A Bayesian Analysis From the BNP Multinational Study. J Am Coll Cardiol
2002;39:140A.
A62)
McCullough PA, Nowak RM, McCord J, Hollander JE, Loh E, Steg G, Duc P, Omland T,
Westheim A, Abraham WT, Storrow AB, Wu AH, Hlavin P, Maisel AS, for the BNP Multinational
Study Investigators. The Independent Contribution to Elevations in B-Type Natriuretic Peptide
from Atrial Fibrillation. J Am Coll Cardiol 2002;39:90A.
A63)
Maisel AS, Kazanegra R, McCord J, Nowak RM, Hollander JE, Duc P, Steg G, Omland T, Wold-
Knudsen C, Westheim A, Abraham WT, Storrow AB, Wu AH, McCullough PA, for the BNP
Multinational Study Investigators. The Effect of Diabetes on B-Type Natriuretic Peptide Levels in
Patients with Acute Dyspnea. J Am Coll Cardiol 2002;39:182A.
A64)
McCullough PA, Nowak RM, Foreback C, Borzak S, Tokarski G, Tomlanovich MC, Jacobsen G,
Weaver WD, Sandberg KR, McCord J. Performance of Cardiac Troponin I in the Exclusion of
Myocardial Infarction in Patients with Advanced Renal Disease. J Am Coll Cardiol 2002;39:326A.
A65)
Khandelwal A, McKinnon JE, Shenkman HJ, Pampati V, Nori D, Kaatz S, Sandberg KR,
McCullough PA. Epidemiology of Systolic and Diastolic Dysfunction Heart Failure in 3,471 Urban
Patients. J Am Coll Cardiol 2002;39:192A.
A66)
Maisel AS, Kazanegra R, McCord J, Nowak RM, Hollander JE, Duc P, Steg G, Omland T,
Westheim A, Abraham WT, Storrow AB, Lamba S, Wu AH, McCullough PA, for the BNP
Multinational Study Investigators. Primary Results of the BNP Multinational Study: B-Type
Natriuretic Peptide in the Emergency Diagnosis of Heart Failure. J Am Coll Cardiol
2002;39:201A.
A67)
McCullough PA, McCord J, Nowak RM, Hollander JE, Duc P, Omland T, Abraham WT, Wu
AHB, Krishnaswamy P, Maisel AS. B-type Natriuretic Peptide Should be Part of the Diagnostic
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Evaluation of Heart Failure: Implications from the Breathing Not Properly (BNP) Multinational
Study. J Heart Failure 2002;7(1):44.
A68)
Nowak RM, Maisel AS, McCord J, Kazanegra R, Hlavin P, Lenert LA, Clopton P, Hollander JE,
Loh E, Duc P, Steg PG, Westheim A, Omland T, Abraham WT, Lamba S, Storrow AB, Wu AHB,
McKay C, McCullough PA. B-type Natriuretic Peptide Complements Clinical Judgment in the
Emergency Diagnosis of Heart Failure. Acad Emerg Med 2002 9: 359.
A69)
Hollander JE, Maisel AS, Nowak RM, McCord J, Kazanegra R, Hlavin P, Lenert LA, Clopton P,
Loh E, Duc P, Steg PG, Wertheimer A, Omland T, Abraham WT, Lamba S, Storrow AB, Wu AHB,
McKay C, McCullough PA. Impact of Acute Myocardial Ischemia on Blood B-Type Natriuretic
Peptide in the Emergency Diagnosis of Heart Failure. Acad Emerg Med 2002 9: 440.
A70)
Knudsen CW, Omland T, Clopton P, Westheim A, Abraham WT, Storrow AB, McCord J,
Nowak RM, Steg PG, Duc P, McCullough PA, Maisel AS. Diagnostic Value of Chest Radiographs
in Patients Presenting with Acute Dyspnea: Comparison with B-type Natriuretic Peptide.
Circulation 2002;106(19):II-683.
A71)
Omland T, Knudsen CW, Westheim A, McCord J, Aumont MC, McCullough PA. The Effect of
Hypertension on B-type Natriuretic Peptide Levels in Patients with Acute Dyspnea: An Analysis
from the Breathing Not Properly Study. Circulation 2002;106(19):II-477.
A72)
Sallach JA, McCord J, Sallach SM, Duc P, Omland T, Nowak RM, Hollander JE, Storrow AB,
Abraham WT, Wu AHB, Clopton P, Krishnaswamy P, Maisel AS, McCullough PA. The Effect of
Pre-Existing Ischemic Heart Disease on B-type Natriuretic Peptide Levels in Patients Presenting
with Acute Dyspnea. Circulation 2002;106(19):II-565.
A73)
Ehrman JK, Manhapra A, Jacobsen G, McCullough PA. Lower Socioeconomic Status is
Associated with Poor Survival in Heart Failure Patients. Circulation 2002;106(19):II-762.
A74)
McCullough PA, Omland T, Knudsen CW, Duc P, Nowak RM, McCord J, Hollander JE, Aumont
MC, Steg PG, Westheim A, Storrow AB, Abraham WT, Lamba S, Wu AHB, Alan S. Maisel AS, BNP
Multinational Study Investigators. Uncovering Heart Failure in Patients with Bronchospasm:
Rationale for the Early Use of B-Type Natriuretic Peptide in the Emergency Department. J Am
Coll Cardiol 2003;41:142A.
A75)
Maisel AS, Kazanegra R, McCullough PA, McCord J, Nowak RM, Hollander JE, Wu AHB, Duc P,
Omland T, Storrow AB, Krishnaswamy P, Abraham WT, Clopton P, Steg PG, Westheim A,
Knudsen CW, Herrmann HC. Bedside B-Type Natriuretic Peptide in the Emergency Diagnosis of
Systolic and Nonsystolic Heart Failure: Results From the Breathing Not Properly (BNP)
Multinational Study. J Am Coll Cardiol 2003;41:143A.
A76)
Steg PG, Duc P, Joubin L, McCord J, Abraham WT, Hollander JE, Omland T, Baron G, Aumont
MC, Mentré F, McCullough PA, Maisel AS, BNP Multinational Study Investigators. A Comparison
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of Bedside B-Type Natriuretic Peptide Versus Echocardiographic Determination of Ejection
Fraction in the Diagnosis of Heart Failure. J Am Coll Cardiol 2003;41:337A.
A77)
Mundy BJ, McCord J, Nowak RM, Hudson MP, Czerska B, Jacobsen G, Omland T, Wu AHB,
Duc P, Hollander JE, McCullough PA, Maisel AS, BNP Multinational Study Investigators. B-Type
Natriuretic Peptide Levels Are Inversely Related to Body Mass Index in Patients With Heart
Failure. J Am Coll Cardiol 2003;41:158A.
A78)
McCullough PA, Nowak RM, McCord J, Omland T, Knudsen CW, Duc P, Hollander JE, Steg PG,
Aumont MC, Westheim A, Storrow AB, Abraham WT, Lamba S, Wu AHB, Maisel AS, BNP
Multinational Study Investigators. What is in the Differential Diagnosis of a B-Type Natriuretic
Peptide Level of 1,000 pg/ml? J Am Coll Cardiol 2003;41:159A.
A79)
McCullough PA, Steg PG, Aumont MC, Duc P, Omland T, Knudsen CW, Nowak RM, McCord J,
Hollander JE, Westheim A, Storrow AB, Abraham WT, Lamba S, Wu AHB, Maisel AS, BNP
Multinational Study Investigators. What Causes Elevated B-Type Natriuretic Peptide in Patients
Without Heart Failure? J Am Coll Cardiol 2003;41:278A.
A80)
Gurudutt B. Kulkarni, John House, John A. Spertus, Peter A. McCullough. Chronic Kidney
Disease: The Silent Killer After Coronary Angioplasty. J Am Coll Cardiol 2003;41:54A.
A81)
Chew DP, Bhatt DL, Berger PB, Henry T, McCullough PA, Feit F, Bittl JA, Lincoff AM.
Bivalirudin Provides Increasing Benefit With Declining Renal Function in Percutaneous Coronary
Intervention: A Meta-Analysis of 5,035 Patients Enrolled in Three Randomized Trials. J Am Coll
Cardiol 2003;41:83A.
A82)
Stone GW, McCullough PA, Tumlin J, Madyoon H, Murray P, Wang A, Chu AA, Schaer G,
Stevens M, Wilensky RL, O'Neill WW, Lepor N. A Prospective, Randomized Placebo-Controlled
Multicenter Trial Evaluating Fenoldopam Mesylate for the Prevention of Contrast Induced
Nephropathy: The CONTRAST Trial. J Am Coll Cardiol 2003;41:83A.
A83)
McCullough PA, Duc P, Omland T, McCord J, Nowak RM, Hollander JE, Herrmann HC, Steg
PG, Westheim A, Aumont MC, Knudsen CW, Storrow AB, Abraham WT, Lamba S, Wu AHB, Perez
A, Clopton P, Krishnaswamy P, Kazanegra R, Maisel AS, BNP Multinational Study Investigators.
B-Type Natriuretic Peptide and Renal Function in the Diagnosis of Heart Failure: An Analysis
from the BNP Multinational Study. J Am Coll Cardiol 2003;41:222A.
A84)
McCullough PA, Sandberg KR, Yanez J. Determinants of vascular calcification in patients
with chronic kidney disease and end-stage renal disease: a systematic review. Am J Kidney Dis
2003;(42)227A.
A85)
Kazanegra R, Clopton P, Krishnaswamy P, Nowak RM, McCord J, Hollander JE, Duc P, Omland
T, Storrow AB, Abraham WT, Wu AH, Steg PG, Westheim A, Perez A, Herrmann HC, Knudsen CW,
Aumont M-C, McCullough PA, Maisel AS. The impact of age, race and gender on the ability of B-
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type natriuretic peptide to aid in the emergency diagnosis of heart failure: results from the
breathing not properly (BNP) multinational study. J Cardiac Failure 2003; 9(5):S36.
A86)
Aumont MC, Duc P, Baron G, McCord JA, Omland T, Storrow AB, McCullough PA, Maisel AS.
High levels of brain natriuretic peptide without chronic heart failure: analysis of a multicentre
study. Eur Heart J 2003;24(530): P2810.
A87)
Havranek EP, Masoudi FA, Rumsfeld JS, Luther SA, McCullough PA, Jones PG, Rathore SS.
Changes in BNP are not associated with outcomes in outpatients with heart failure. Circulation
2003;108(17):IV-692.
A88)
Sandberg KR, Gallagher MJ, Krause KR, Franklin BA, McCullough PA. Caloric expenditure in
the morbidly obese. Circulation 2003;108(17):IV-735.
A89)
Gallagher MJ, Sandberg KR, de Jong A, Krause KR, McCullough PA, Franklin BA. Heart rate
recovery after symptom limited exercise testing in obese patients. Circulation 2003;108(17):IV-
735.
A90)
Fishbane S, McCullough PA, Rudnick M. Systematic Review of the Role of N-acetylcysteine
in the Prevention of Contrast Media-Induced Nephropathy. J Am Soc Nephrol Vol 14, 2003,
1553A.
A91)
Stacul F, Bertrand ME, McCullough PA, Brinker J. Contrast-induced nephropathy (CIN)
following iso-osmolar (IOCM) versus low-osmolar contrast media (LOCM) in patients undergoing
angiography and predicting factors for CIN: a meta-analysis. European Congress of Radiology
2004, B-934.
A92)
Maisel AS, Hollander J, Guss D, McCullough PA, Nowak R, Green G, Saltzberg M, Kazanegra
R, Clopton P, Jesse R, for the REDHOT Investigators. Primary results of the Rapid Emergency
Department Heart Failure Outpatient Trial (REDHOT): a multicenter trial examining B-type
natriuretic peptide levels, emergency physician decision making and outcomes in patients with
shortness of breath. J Am Coll Cardiol 2004; 43(5):6A.
A93)
Knudsen CW, Omland T, Westheim A, Clopton P, Abraham WT, Storrow A, McCord JK,
Nowak R, Duc P, McCullough PA, Maisel A. B-type natriuretic peptide and chest radiograph
findings as indicators of systolic dysfunction in patients presenting with acute dyspnea. J Am
Coll Cardiol 2004; 43(5):171A.
A94)
Soman P, Lahiri A, Mieres J, Calnon D, Wolinsky D, Beller GA, Sias T, Burnham K, Conway L,
McCullough PA, Daher E, Walsh MN, Wight J, Heller GV, Udelson JE. Investigation of
Myocardial-Gated SPECT Imaging as an Initial Strategy in Heart Failure: The IMAGING in Heart
Failure Study. J Am Coll Cardiol 2004;43(5):323A.
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A95)
Maisel AS, Bhalla MA, Gardetto N, McCord J, Nowak RM, Hollander JE, Wu AHB, Duc P,
Omland T, Storrow AB, Krishnaswamy P, Abraham WT, Clopton P, Steg G, Aumont MC,
Westheim A, Knudsen CW, Perez A, Kamin R, Kazanegra R, Herrmann HC, McCullough PA, for
the BNP Multinational Study Investigators. Utility of B-type natriuretic peptide levels in
predicting outcome of hospitalized patients with congestive heart failure: results of the
Breathing Not Properly (BNP) Multinational Study. J Am Coll Cardiol 2004; 43(5):234A.
A96)
Sandberg KR, Irving SD, Veri S, McCullough PA. Dietary and exercise habits in morbidly
obese patients pre and post gastric bypass surgery. Presented at the 44th Annual Conference on
Cardiovascular Disease Epidemiology and Prevention. Circulation 2004;109(6):P233.
A97)
Sandberg KR, Gallagher MJ, Franklin BA, deJong AT, Krause KR, McCullough PA. The effects
of bariatric surgery on exercise tolerance and cardiopulmonary fitness in the morbidly obese.
American Society for Bariatric Surgery Annual Meeting 2004 [P7].
A98)
Odom JS, Sandberg KR, McCullough PA. Psychological screening in bariatric surgery
candidates. American Society for Bariatric Surgery Annual Meeting 2004 [P51].
A99)
de Jong AT, Gallagher MJ, Sandberg KR, Krause KR, Ehrman JK, Keteyian SJ, Brawner CA,
McCullough PA, Franklin BA. Ability to achieve maximal oxygen consumption during exercise
testing in morbidly obese patients. Medicine & Science in Sports and Exercise 2004;36(4):S140
[999].
A100) Conklin A, de Jong AT, Franklin BA, McCullough PA. Evaluation of cardiorespiratory fitness in
morbidly obese adults: a feasibility study. Medicine & Science in Sports and Exercise
2004;36(4):S140 [1000].
A101) Grayson D, De Jong AT, Ochoa A, Gallagher M, Franklin BA, McCullough PA. Oxygen
consumption changes during EECP treatment in patients with and without coronary artery
disease. Medicine & Science in Sports and Exercise 2004;36(4):S140 [1475].
A102) Jurkovitz C, Norris K, Li S, Shen SC, McGill JA, McCullough PA, Narva A, Bakris G, Collins A,
Klag M, Brown W. Does Obesity Modify the Association between Hypertension and Race? An
Analysis of the KEEP Population. Preventive Medicine 39(2004), S21.
A103) Strunk A, Bhalla V, Clopton P, Nowak RM, McCord J, Hollander JE, Duc, P, Storrow, AB,
Abraham WT, Wu AHB, Steg G, Perez A, Kazanegra R, Herrmann HC, Aumont MC, McCullough
PA, Maisel AS for the BNP Multinational Study Investigators*. Impact of the history of
congestive heart failure on accuracy of BNP in the emergency diagnosis of heart failure: results
from the breathing not properly (BNP) multinational study. J Card Failure 10(4):S50 #120, 8th
Annual Scientific meeting of the Heart Failure Society of America, 2004.
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A104) Jurkovitz C, Li S, Norris K, McGill J, Chen SC, Pergola P, Narva A, McCullough PA, Brown W,
Klag M. Obesity is associated with risk factors for chronic kidney disease: Kidney Early
Evaluation Program Results. J Am Soc Nephrol 2004;15:134A.
A105) Singh AK, McGill J, McCullough PA, Brown W, Collins A, Chen SC, Li S, Narva A, Herman WH,
Bakris GL, Jurkovitz C, Norris K, Pergola P, Klag M. Advanced stages of chronic kidney disease
(CKD) detected among screened individuals with diabetes mellitus, undiagnosed diabetes, and
mildly elevated glucose values: Results from the NKF Kidney Early Evaluation Program (KEEP)
Study. J Am Soc Nephrol 2004;15:322A.
A106) McGill J, McCullough PA, Brown W, Collins A, Chen SC, Li S, Narva A, Herman WH, Bakris GL,
Norris K, Pergola P, Klag M, Jurkovitz C. Pre-menopausal and elderly women with chronic
kidney disease (CKD) at highest risk of anemia: Results from the NKF Kidney Early Evaluation
Program (KEEP) Study. J Am Soc Nephrol 2004;15:547A.
A107) Gallagher MJ, Franklin BA, deJong A, Sandberg KR, Krause KR, Ehrman JK, Keteyian SJ,
Brawner CA, Mattichak SJ, Kahn JK, McCullough PA. Cardiorespiratory fitness levels in obesity
approximate those of heart failure patients: implications for exercise prescription. Circulation
2004;110(17)822A.
A108) Knudsen CW, Clopton P, Klemsdal TO, Westheim A, Wu A, Abraham WT, Storrow AB,
McCord JK, Nowak RM, McCullough PA, Omland T. Predictors of absence of heart failure in
patients with elevated B-type natriuretic peptide levels. 2004;110(17)368A.
A109) Daniels LB, Clopton P, Hollander JE, Guss D, McCullough P, Nowak R, Green G, Saltzberg M,
Ellison SR, Bhalia MA, Bhalia V, Jesse R, Maisel A. Effect of ethnicity on likelihood of admission
for heart failure. J Am Coll Cardiol 2005;45(3)168A.
A110) McCullough PA, Brown WW, McGill JB, Collins AJ, Chen SC, Li S, Singh AK, Narva AS, Herman
WH, Bakris GL, Jurkovitz CT, Norris KC, Pergola P, Klag MJ, for the KEEP Investigators.
Independent components of chronic kidney disease as a cardiovascular risk factor; results from
the Kidney Early Evaluation Program (KEEP). J Am Coll Cardiol 2005;45(3)424A.
A111) McCullough PA, Klag MJ, McGill JB, Collins AJ, Chen SC, Li S, Singh AK, Narva AS, Herman WH,
Bakris GL, Jurkovitz CT, Norris KC, Pergola P, Brown WW, for the KEEP Investigators. Age over 30
becomes a cardiovascular risk factor in patients screened for chronic kidney disease, results
from the Kidney Early Evaluation Program (KEEP). J Am Coll Cardiol 2005;45(3)434A.
A112) Daniels LB, Clopton P, Chiu A, McCord J, Hollander JE, Duc P, Omland T, Storrow AB, Wu AHB,
Steg G, Westheim A, Knudsen CW, Hermann HC, McCullough PA, Maisel AS. Using B-type
natriuretic peptide to diagnose heart failure in obese patients. J Am Coll Cardiol
2005;45(3)141A.
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A113) Trivax JE, Gallagher MJ, Alexander DV, deJong AT, Kasturi G, Sandberg KR, Jafri SM, Krause
KR, Chengelis DL Moy J, Franklin BA, McCullough PA. Poor aerobic fitness predicts
complications associated with bariatric surgery. CHEST 2005;128(4)282S.
A114) Miller WM, Nori KE, Sandberg KR, Vial C, VanderLinden M, McCullough PA. Change in C-
reactive protein levels with weight loss following gastric bypass surgery. Circulation
2005;111(14) P213.
A115) Moy J, Gallagher M de Jong A, Sandberg K, Trivax J, Alexander D, Kasturi G, Jafri S, Krause K,
Chengelis D, Franklin B, McCullough P. Preoperative cardiopulmonary fitness predicts surgical
complications after laparoscopic roux-en-Y gastric bypass surgery for morbid obesity. Obesity
Research 2005;13, A14 (54-OR).
A116) Nori Janosz K, Koenig K, Leff C, Miller W, McCullough P. How much weight needs to be lost
to resolve type 2 diabetes? Obesity Research 2005;13, A59 (229-P).
A117) Odom J, Ferrara M, McCullough P, Miller W. The effect of behavioral group attendance on
weight loss while participating in an out-patient, hospital-based, meal replacement program.
Obesity Research 2005;13, A144 (557-P).
A118) Miller W, Veri S, Odom J, Lillystone M, Gibbs D, McCullough P. Effects of a short-term
multidisciplinary program for childhood obesity. Obesity Research 2005;13, A84 (328-P).
A119) Odom J, Ferrara M, McCullough P, Miller W. The effect of psychosocial factors on weight
loss during an out-patient, hospital-based, meal replacement program. Obesity Research
2005;13, A69 (267-P).
A120) Vanhecke TE, Miller WM, Franklin BA, Weber JE, McCullough PA. Differences in health
awareness knowledge, environmental tobacco smoke exposure (ETS), and body-shape
perception among adolescents based upon body mass index. J Am Coll Cardiol 2006;47(4) 247A.
A121) Duru K, Jurkovitz C, Narva A, McGill J, Bakris G, Chen SC, Lu S, Pergola P, McCullough P, Singh
A, Klag M, Collins A, Brown W, Norris K. Racial and gender differences in hypertension control
and chronic kidney disease: results from the Kidney Early Evaluation Program (KEEP). NKF 2006
Spring Clinical Meetings; 245: P101.
A122) Conklin A, de Jong A, McCullough PA, Franklin B. Cardiorespiratory Fitness: Relation to Body
Mass Index among the Morbidly Obese and Superobese. Med Sci Sports Exerc. 2006 May;38(5
Suppl):S84-5.
A123) Miller WM, Khazaal N, Nori-Janosz K, Franklin B, Vial C, Kaitner R, McCullough P. Advantages
of group treatment and exercise promoting short-term weight loss in obese adults. Obesity
2006;14(Suppl):A157.
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A124) McCullough PA. Which Types and Which Amount of Physical Activities to Achieve and
Maintain a Healthy Body Weight? 4th Metabolic Syndrome, Type II Diabetes, and
Atherosclerosis Congress (MSDA), 2007, AL-18, p 23.
A125) Vanhecke TE, McCullough PA, Trivax J, DeJong A, Franklin BA. Energy Expenditure, Epicardial
Adipose Tissue and Cardiorespiratory Fitness in Morbidly Obese Adults: 2154: Board #67 June 1
8:00 AM - 9:30 AM. Med Sci Sports Exerc. 2007 May;39(5 Suppl):S385.
A126) Miller WM, Veri S, Odom J, Lillystone M, Washington T, McCullough PA, Franklin BA. Dietary
behaviors and knowledge among urban pre-adolescents: 1581: board #71 may 30 3:30 PM - 5:00
PM. Med Sci Sports Exerc. 2007 May;39(5 Suppl):S247.
A127) DeJong AT, McCullough P, Franklin B. Use of VE/VCO2 slope Corrected for Peak VO2 as a
Predictor of Post-Surgical Complications in Morbidly Obese Patients: 686: May 31 8:30 AM 8:45
AM. Med Sci Sports Exerc. 2007 May;39(5 Suppl):S40.
A128) Zalesin KC, Krause KR, Chengelis DL, McCullough PA. Determinants of the Resolution of Type
2 Diabetes after Bariatric Surgery. American Society of Bariatric Surgery. Surgery for Obesity and
Related Disorders 3(3):314; 2007.
A129) Kadaj P, Vanhecke T, Barnes MA, Lazar MH, Gandhi M, McCullough, PA. Natriuretic peptide
testing and APACHE II scores for the evaluation and prediction of outcome in acutely ill patients:
a prospective cohort study. Chest 2007;132(4) 551S.
A130) Agrawal V, Khan I, Rai B, Krause KR, Chengelis DL, Zalesin KC, Rocher LL, McCullough PA.
Weight loss after bariatric surgery reduces albuminuria in obese adults with diabetes. J Am Soc
Nephrol, Oct 2007; 18: 574A.
A131) Agrawal V, Rai B, Khan I, Krause KR, Chengelis DL, Zalesin KC, Rocher LL, McCullough PA.
Weight loss after bariatric surgery reduces albuminuria in obese adults. J Am Soc Nephrol, Oct
2007; 18: 767A.
A132) O’Donoghue M, Sabatine M, Boden WE, Braunwald E, Cannon CP, Clayton TC, de Winter RJ,
Fox KA, Lagerqvist B, McCullough PA, Murphy SA, Spacek R, Swahn E, Wallentin L, Windhausen
F. The benefit of early invasive strategy in women versus men with non-ST-elevation acute
coronary syndromes: a collaborative meta-analysis of randomized trials. Circulation
2007:116(16);II-383.
A133) Boerrigter G, Costello-Boerrigter LC, Abraham WT, St. John Sutton, MG, Heublein D, Kruger
KM, Hill MR, McCullough PA, Burnett JC. Cardiac resynchronization therapy with biventricular
pacing improves renal function in heart failure patients with reduced glomerular filtration rate.
Circulation 2007:116(16);II-405.
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A134) Deliri H, Davis E, Hager CS, Welch CA, Malik FS, McCullough PA, Wagner GS, Carter WH. A
prospective randomized trial of blood B-type natriuretic peptide levels informing management
after elective coronary artery bypass surgery. Circulation 2007:116(16);II-683.
A135) McCullough PA, Li S, Collins AJ, Chen SC, Jurkovitz CT, Norris KC, McFarlane S, Johnson B,
Shlipak M, Obialo C, Brown WW, Vassaloti J, Bakris GL, for the KEEP Investigators. Chronic
kidney disease and risk for premature cardiovascular disease. Circulation 2007:116(16);II-852.
A136) McCullough PA, Leifer E, Ellis S, Rendall DS, Horwich T, Hill JA, Fonarow GC. Relationship
between renal function and cardiopulmonary fitness in patients with systolic heart failure. J Am
Coll Cardiol 2008;51(10)A52-53.
A137) O’Donoghue, Boden WE, Cannon CP, Clayton TC, de Winter RJ, Fox KA, Lagerqvist B,
McCullough PA, Murphy SA, Spacek R, Swahn E, Wallentin L, Windhausen F, Sabatine MS. The
benefit of an invasive strategy in diabetic versus non-diabetic subjects with non-ST segment
elevation acute coronary syndromes; a collaborative meta-analysis of randomized trials. J Am
Coll Cardiol 2008;51(10)A216.
A138) McCullough PA, Li S, Jurkovitz CT, Stevens LA, Wang C, Collins AJ, Chen SC, Norris KC,
McFarlane S, Johnson B, Shlipak MG, Obialo CI, Brown WB, Vassalotti JA, Whaley-Connel AT, for
the KEEP Investigators. Chronic kidney disease and cardiovascular disease in volunteer and
randomly selected populations: KEEP and NHANES. Am J Kidney Dis 2008;51(4)B68.(Abstract
#162)
A139) McFarlane SI, Chen SC, Whaley-Connell A, Sowers J, Vassalotti JA, Salifu MO, Li S, Wang C,
Bakris G, McCullough PA, Collins AJ, Norris K for the KEEP Investigators. Racial and gender
differences in prevalence and predictors of anemia of chronic kidney disease: KEEP and NHANES
1999-2004. Am J Kidney Dis 2008;51(4)B68. (Abstract #163)
A140) Pavey BS, Saab G, McFarlane SI, Sowers JR, Chen S, Li S, Vassalotti J, Collins AJ, Norris K,
McCullough PA, Bakris G, Whaley-Connell A, for the KEEP Investigators. Prevalent components
of cardiometabolic syndrome and cardiovascular disease from the Kidney Early Evaluation
Program (KEEP). Am J Kidney Dis 2008;51(4)B79. (Abstract #207)
A141) Agrawal V, Vanhecke TE, Franklin BA, Zalesin KC, Sangal RB, Hakmeh B, deJong AT,
McCullough PA. Albuminuria in obese adults is associated with hypertension and sleep
disturbance. Am J Kidney Dis 2008;51(4)B29. (Abstract #5)
A142) Vassalotti JA, Uribarri J, Chen SC, Li S, Wang C, Collins AJ, Calvo MS, Whaley-Connell A, Norris
KC, McCullough PA, Andress DL, for the KEEP Investigators. Trends in mineral metabolism in the
kidney early evaluation program (KEEP). Am J Kidney Dis 2008;51(4)B52. (Abstract #75)
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A143) Agrawal V, Krause KR, Chengelis DL, Zalesin K, Rocher L, McCullough PA. Relation between
degree of weight loss after bariatric surgery and reduction in high sensitivity C-reactive protein.
Surgery for Obesity and Related Diseases 2008;3(4)324.(Abstract P33)
A144) Odom J, Washington TL, Zalesin K, McCullough PA, Hakmeh B. Psychosocial trends related
to weight regain after bariatric surgery. Surgery for Obesity and Related Diseases
2008;3(4)324.(Abstract BH-04)
A145) McCullough PA. New insights on accelerated vascular calcification in patients with kidney
disease. J Heart Dis 2008;(6):121 (Abstract 482).
A146) Agrawal V, Ghoshi AK, Barnes MA, McCullough PA. Perception of indications for nephrology
referral among internal medicine residents. A national online survey. J Am Soc Neph
2008;19:812-13A (SA-PO3091).
A147) Agrawal V, Swami A, Al-Sabbagh M, Kosuri R, Samarapungavan D, McCullough PA. Contrast
induced acute kidney injury in renal transplantation recipients undergoing cardiac
catheterization. J Am Soc Neph 2008;19:986-87A (PUB766).
A148) Agrawal V, Agarwal M, Barnes MA, Ghosh AK, McCullough PA. Internal medicine resident’s
knowledge of chronic kidney disease complications and management: a national survey. NKF
2009 Spring Clinical Meetings; 43: I22.
A149) Li S, Chen SC, Vassaloti J, Norris K, McCullough PA, Bakris G, Collins A. Predictors of self-
referred repeat CKD screening in the Kidney Early Evaluation Program (KEEP). NKF 2009 Spring
Clinical Meetings; 48: I42.
A150) Whaley-Connell, Sowers JR, McCullough PA, Roberts T, McFarlane SI, Chen SC, Li S, Wang C,
Collins AJ, Bakris GL, and the Kidney Early Evaluation Program Investigators. Diabetes mellitus
and CKD awareness: the Kidney Early Evaluation Program and the National Health and Nutrition
and Examination Survey. NKF 2009 Spring Clinical Meetings; 52: I60.
A151) Kalatizidis R, Li S, Wang C, Chen SC, McCullough PA, Bakris G. Hypertension in early-stage
kidney disease: an update from the kidney early evaluation program. NKF 2009 Spring Clinical
Meetings; 80: I170.
A152) Agrawal V, Agarwal M, Samarapungavan D, McCullough PA. Long term outcomes of
contrast induced acute kidney injury in renal transplant recipients. NKF 2009 Spring Clinical
Meetings; 83: I184.
A153) McCullough PA, Whaley-Connell A, Brown WW, Collins AJ, Chen SC, Li S, Norris KC, Johnson
BC, Calhoun D, Jurkovitz C, McFarlane S, Obialo C, Shlipak M, Sowers J, Stevens L, Vassalotti JA,
Bakris GL. Cardiovascular risk modification in chronic kidney disease patients with coronary
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disease: results from the Kidney Early Evaluation Program (KEEP). J Am Coll Cardiol
2009;53(10):A224.
A154) Kosiborod M, McCullough PA, Rao S, Inzucchi SE, Maddox TM, Masoudi FA, Xiao L, Fiske S,
Spertus JA. Hyperglycemia and risk of acute kidney injury after coronary angiography in patients
hospitalized with acute myocardial infarction. J Am Coll Cardiol 2009;53(10):A382.
A155) Miller WM, Veri S, McCullough PA, Franklin BA. Children improve nutritional knowledge,
increase physical activity and reduce body mass through a multidisciplinary school intervention.
Poster: 2009 American College of Sports Medicine Annual Meeting; 2009 May 27; Seattle, WA.
Medicine and Science in Sports and Exercise 2009;41(5):S1543.
A156) Zalesin, KC, Franklin BA, Lillystone M, Shamoun T, Krause K, Chengelis D, Mucci S, Shaheen
KW, McCullough PA. Differential loss of fat and lean mass in the morbidly obese after bariatric
surgery. Surgery for Obesity and Related Diseases 2009;5: S29 (poster) awarded Outstanding
Poster Recognition
A157) Miller WM, Franklin BA, Veri S, Maaz Y, Jameel J, McCullough PA. Is degree of obesity
associated with childhood obesity treatment outcomes? Poster: The Obesity Society’s Annual
Scientific Meeting; 2009 Oct 26; Washington, DC. Obesity 2009;17(2):S184
A158) Trivax JE, Franklin BA, Goldstein JA, Chinnaiyan KM, Gallagher MJ, deJong AT, Colar JM,
Haines DE, McCullough PA. Acute cardiac effects of marathon running: evidence for right heart
overload. Circulation 2009;120 (18): S513
A159) Amin AP, Riley K, Spertus JS, Venkitachalam L, Stolker JM, McCullough PA, Masoudi FA,
Jones PG, Kosiborod M. Trends in the prevalence of acute kidney injury in patients with acute
myocardial infarction. J Am Coll Cardiol 2010;55 (10): A102 (1046-282)
A160) Agrawal V, Garimella PS, Jaar BG, Plantinga L, Ye J, McCullough PA. Access to health care in
adults evaluated for chronic kidney disease: findings from the Kidney Early Evaluation Program.
NKF 2010 Spring Clinical Meetings, April 13-17, 2010, P35.
A161) Bomback AS, Kshirsagar AV, Whaley-Connell AT, Chen SC, Li S, Klemmer PJ, McCullough PA,
Bakris GL. Racial differences in kidney function among individuals with obesity and metabolic
syndrome: results from the Kidney Early Evaluation Program (KEEP). NKF 2010 Spring Clinical
Meetings, April 13-17, 2010, P45.
A162) Saab G, Whaley-Connell A, Chen SC, Li S, Sowers JR, Norris K, Bakris G, McCullough PA. The
association of serum phosphorus and pulse pressure in men and women with chronic kidney
disease: data from the Kidney Early Evaluation Program. NKF 2010 Spring Clinical Meetings,
April 13-17, 2010, P80.
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A163) McCullough PA, Brown J, Weisbord S. The effects of iso-osmolar contrast media on
contrast-induced acute kidney injury: a meta-analysis. Cath Cardiovasc Interv 2010;75(6):S78,
B-034.
A164) McCullough PA, Capasso P. Patient discomfort associated with the use of intravascular
iodinated contrast media: a meta-analysis of comparative randomized trials. Cath Cardiovasc
Interv 2010;75(6):S80, B-037.
A165) Miller WM, Spring TJ, Zalesin KC, Kaeding K, deJong AT, McCullough PA, Franklin, BA.
Resting metabolic rate is directly associated with cardiorespiratory fitness in the morbidly obese.
Poster: AHA Annual Conference on Nutrition, Physical Activity and Metabolism; 2010 March 2;
San Francisco, CA. Circulation 2010 March; Suppl. Page 114, Poster P75.
A166) Miller WM, So NC, Zalesin KC, Spring TJ, Kaeding K, Krause K, Chengelis D, deJong AT,
Franklin BA, McCullough PA. Low resting metabolic rate is associated with low cardiorespiratory
fitness, low vitamin D and hyperuricemia in bariatric surgery patients. Poster P-41: 27th Annual
Meeting of the American Society for Metabolic and Bariatric Surgery; 2010 June 24; Las Vegas,
NV. Surgery for Obesity and Related Diseases 2010;6:S41.
A167) Spring TJ, Franklin BA, McCullough PA, Miller W, Zalesin K, Kaeding K, deJong AT. Reduced
resting oxygen consumption in the morbidly obese: Implications for exercise prescription.
Poster: AHA Annual Conference on Nutrition, Physical Activity and Metabolism; 2010 March 2;
San Francisco, CA. Circulation 2010 March; Suppl. Page 102, Poster P29.
A168) Vanhecke TE, Franklin BA, Soman P, Lahiri A, Mieres JH, Sias T, Calnon D, Wolinsky D, Beller
G, Burnham K, Conway L, Wight J, Walsh M, Daher E, Heller G, Udelson JE, McCullough PA.
Influence of Myocardial Ischemia on Outcomes in Patients with Systolic Versus Non-Systolic
Heart Failure. Journal of the American College of Cardiology Volume 57, Issue 14, Supplement, 5
April 2011, Page E2015. Best Fellow-in-Training Poster.
A169) Babyev R, Whaley-Connell A, Kshirsaga AV, Navaneethan S, Chen SC, Li S, McCullough PA,
Bakris GL, Bomback AS, for the KEEP Investigators. Race does not influence ESRD and mortality
in obese patients with CKD stages 3-4: results from the Kidney Early Evaluation Program. NKF
2010 Spring Clinical Meetings, Las Vegas, NV, April 24-30, 2011, P55.
A170) Bose S, Mehta NN, Chen SC, McCullough PA, for the KEEP Investigators. Poor glycemic
control but not dyslipidemia is associated with albuminuria in patients with CKD and type 2
diabetes mellitus: a Kidney Early Evaluation Program report. NKF 2011 Spring Clinical Meetings,
Las Vegas, NV, April 24-30, 2011, P56.
A171) Whaley-Connell A, Saab G, Szpunar S, Stevens L, Shlipak M, Bomback A, Tamura MK,
McFarlane S, Li S, Chen SC, Collins A, Norris K, Bakris G, McCullough, PA, for the KEEP
Investigators. Disease state awareness, kidney disease, and relationship to ESRD and death.
NKF 2011 Spring Clinical Meetings, Las Vegas, NV, April 24-30, 2011, P121.
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A172) Shah A, Fried L, Chen SC, Qiu Y, Li S, Cavanaugh K, Norris KC, Whaley-Connell AT, McCullough
PA, Mehrotra R. Associations between access to care and awareness of chronic kidney disease.
NKF 2012 Spring Clinical Meetings, Washington, DC, May 9-13, 2012, P170.
A173) Akrawinthawong K, Shaw M, Kachner J, Apostolov E, Basnakian A. Shah S, Tilak J,
McCullough PA. Urine catalytic iron and neutrophil gelatinase associated lipocalin as
companion early markers of acute kidney injury after cardiac surgery: a prospective pilot study.
NKF 2013 Spring Clinical Meetings, Orlando, FL, April 3-5, 2013, P02. Am J Kidney Disease
2013;61(4):A1.
A174) Mehrotra R, Chen SC, Kestenbaum B, Peralta C, Saab G, Sachs M, Shah A, Li S, Norris K,
Whaley-Connell A. McCullough PA. Serum phosphorus and death or progression to end-stage
renal disease in persons screened in the community for chronic kidney disease. NKF 2013 Spring
Clinical Meetings, Orlando, FL, April 3-5, 2013, P149. Am J Kidney Disease 2013;61(4):A7.
A175) Amin A, Chen SC, Kosiborod M, Whaley-Connell A, Li S, McCullough PA. Synergistic
relationship between eGFR and microalbuminuria in predicting long-term progression to ESRD
or death in patients with piabetes: results from KEEP. NKF 2013 Spring Clinical Meetings,
Orlando, FL, April 3-5, 2013, P176. Am J Kidney Disease 2013;61(4):A8.
A176) Jurkovitz C, Li S, Norris K, Saab G, Bomback A, Whaley-Connell A, McCullough PA.
Association Between Lack of Health Insurance and Risk of Death and ESRD: Results from the
Kidney Early Evaluation Program (KEEP). NKF 2013 Spring Clinical Meetings, Orlando, FL, April 3-
5, 2013, P135. Am J Kidney Disease 2013;61(4):A6.
A177) Larsen TR, Singh G, Velocci V, McCullough PA. Bioimpedience and fluid overload in patients
admitted to the intensive care unit for sepsis syndromes. Blood Purif 2013;35:241.
A178) Manatsathit W, Al-Hamid H, Gill B, Leelasinjaroen P, Hashmi U, Barawi M, McCullough P.
Experience in the management of upper gastrointestinal bleeding and outcomes in patients
taking dabigatran compared with warfarin: a retrospective, comparative study. Am J
Gastroenterol 2013; 108:S464-S465.
A179) Fried LF, Emanuele N, Hongyuan Zhang J, Brophy M, Conner T, Duckworth W, Leehey DJ,
McCullough PA, O’Connor TZ, Palevsky PM, Reilly RF, Seliger SL, Warren S, Watnick S, Peduzzi P,
Guarino P. Combined Angiotensin Inhibition for Treatment of Diabetic Nephropathy: VA
Nephron-D Trial. HI-OR03 J Am Soc Nephrol 24: 2013.
A180) Kumar N, McCullough PA. Epidemiology of Cardiovascular Mortality in Patients with Chronic
Kidney Disease and End-Stage Renal Disease. SA-PO235 J Am Soc Nephrol 24: 2013.
A181) Khan S, McCullough PA, Chawla LS, Beaver TM, Bennett Guerrero E, Wang D, Houser MT.
M13-796 Study Design – A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Safety and
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Effi cacy Trial of Multiple Dosing Regimens of ABT-719 for Prevention of Acute Kidney Injury in
Patients Undergoing High Risk Cardiac Surgeries. PUB013, J Am Soc Nephrol 24: 2013.
A182) Larsen T, Kinni V, Zaks J, David S, McCullough P. A Lethal Case of Influenza and Type 5
Cardiorenal Syndrome. Crit Care Med 2013;41(12 Suppl.):1296.
A183) Akrawinthawong K, Parker G, Stivers D, Cannon L, Dixon S, Ricci J, Kupfer K, Alexander P,
David S, McCullough PA. Subclinical and clinical contrast-induced acute kidney injury: results
from the ENCINO Study. Am J Kidney Dis 2014;63(5):A23
A184) Palazzuoli A, Pellegrini M, Ruocco G, Martini G, Franci B, Campagna MS, Gilleman M, Nuti N,
McCullough PA, Ronco C. Continuous versus bolus intermittent loop diuretic infusion in acutely
decompensated heart failure: a prospective randomized trial. European Heart Journal 2014;
35:386; Suppl 1; Meeting Abstract: 2226; European Society of Cardiology Congress, Barcelona,
Spain, 2014
A185) Shin HJ, McCullough PA, Li S, Cho E, Rimm E, Rosner B, Manson JE, Hu FB. The Association
Between Diet Quality After Diabetes Diagnosis and Major Cardiovascular Events in Women With
Type 2 Diabetes Mellitus. Circulation. 2014;130:A17257
A186) Oudiz R, Meyer C, Chin M, Feldman J, Goldsberry A, McConnell J, McCullough P, O’Grady M,
Tapson V, Torres F, Waxman A, White R. Initial Data Report from "LARIAT": A Phase 2 Study of
Bardoxolone Methyl in PAH Patients on Stable Background Therapy. Chest
2015;148(4_MeetingAbstracts):639A. doi:10.1378/chest.2345856
A187) McCullough PA, Spinowitz B. Novel Agents for the Prevention and Management of
Hyperkalemia. Journal of Managed Care and Speciality Pharmacy, Supplement 21 (10-a),
October 2015: E23.
A188) Haase VH, Hartman CS, Maroni BJ, Farzaneh-Far R, McCullough PA. Vadadustat, a Novel
Oral Treatment for Anemia of Chronic Kidney Disease, Maintains Stable Hemoglobin Levels in
Dialysis Patients Converting from Erythropoiesis-Stimulating Agents. SA-PO1110 J Am Soc
Nephrol 26: 2015.
A189) Palazzuoli A, Ruocco G, Pellegrini M, Franci B, Campagna MS, Nuti R, Ronco C, McCullough
PA. Impact of loop diuretic infusion modalities on congestion signs and outcomes in patients
with acute heart failure. European Heart Journal 2015; 36:672, Suppl 1 Meeting Abstract:
P3791; European Society of Cardiology Congress, London, UK 2015.
A190) Haase V, Hartman C, Maroni B, Farzaneh-Far R, McCullough P. Vadadustat Maintains Stable
Hemoglobin Levels in Dialysis Patients Converting from Erythropoiesis-Stimulating Agent (ESA).
Poster 171. NKF Spring Clinical Meetings, 2016.
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A191) Munkres AG, Vasudevan A, Shin HJ, Sarmast SA, McCullough PA. Abstract 212: Integration
of Multiple Cardiac Biomarkers into a Disease-Specific Score: Relationship to Clinical Status and
Therapeutic Intensity. Circulation: Cardiovascular Quality and Outcomes, March, 2016.
A192) Tecson K, Silver M, Brune S, Cauthen C, Kwan M, Schussler J, Vasudevan A, Watts J,
McCullough PA. Impact of Enhanced External Counterpulsation on Heart Failure
Rehospitalization Among Patients with Ischemic Cardiomyopathy. J Am Coll Cardiol.
2016;67(13_S):1545. doi:10.1016/S0735-1097(16)31546-7.
A193) Prasad A, Morales J, Williams K, Sohn A, Levin D, Khan A, McCullough P, Mehran R, Bailey S.
Contemporary Practice Patterns Related to the Risk of Acute Kidney Injury in the Catherization
Laboratory: Results from an International Survey of Society of Cardiovascular Angiography and
Intervention (SCAI) Cardiologists. Journal of the American College of Cardiology Volume 67, Issue
13, Supplement, 5 April 2016, Page 322
A194) Mazimba S, McCullough P, Rosner M, Mejia-Lopez E, Bilchick K. Changes in Renal Perfusion
Pressure During Hemodynamically Guided Therapy is Associated with Worsening Renal
Function. Journal of the American College of Cardiology Volume 69, Issue 11, Supplement, 21
March 2017, Page 768
A195) Mazimba S, Welch T, McCullough P, Breathett K, Tallaj J, Bergin J, Kennedy J, Smith L,
Abuannadi M, Bilchick B. Systemic Arterial Pulsatility Index (SAPI) Predicts Adverse Outcomes in
Advanced Heart Failure Patients. Journal of the American College of Cardiology Volume 69,
Issue 11, Supplement, 21 March 2017, Page 856
A196) Vasudevan A , McCullough PA, Sathyamoorthy M, Schussler JM, Velasco CE, Lopez LR, Swift
C, Schiffmann R, Bottiglieri T. Abstract 104: Urinary 11-Dehydro-Thromboxane B2 and Mortality
in Patients with Stable Coronary Artery Disease. Scientific Poster Abstracts Selected for the 2016
Congress on Atherosclerotic Cardiovascular Disease Prevention, Sept. 16-18, 2016, Boca Raton,
Florida., Clin Cardiol. 2016 Sep;39 Suppl 1:4-18. doi: 10.1002/clc.22597.
A197) Tecson KM, Hamman BL, Choi JW, Garg P, Olugbode OA, Schussler JM, Stoler RC, Vasudevan
A, Velasco CE, McCullough PA. Abstract 15609: The Effect of Contrast-Induced Acute Kidney
Injury in High Risk Patients Undergoing Cardiac Surgery. Circulation. 2016;134(Suppl 1).
A198) Ballantyne CM, McCullough PA, Sanganalmath SK , Koren A, Letierce A, Davidson MH. Safety
and Efficacy of Alirocumab in Patients With Atherosclerotic Cardiovascular Disease, Based on
Statin Intensity: Pooled Analyses of 5 Placebo-controlled Phase 3 Trials. Circulation.
2016;134:A16873.
A199) Pergola PE, Spinowitz BS, McCullough PA, Singh B, Menoyo JA, Lavin PT, Rasmussen HS,
Fishbane S. Effect of Sodium Zirconium Cyclosilicate Treatment for Hyperkalemia on Blood
Pressure in a Long-Term Open-Label Phase 3 Study. J Am Soc Nephrol 27: 2016 (TH-PO478).
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A200) Golestaneh L, Gaber AO, Kalim S, McCullough PA, Germain MJ. Neutrophil Gelatinase-
Associated Lipocalin (NGAL) Correlates to AKI Stage in ICU Patients. J Am Soc Nephrol 27: 2016
(TH-PO643).
A201) Kalim S, Gaber AO, Golestaneh L, Germain MJ, McCullough PA. Multi Center ICU Study Finds
NGAL Increases Rate of AKI Detection. J Am Soc Nephrol 27: 2016 (TH-PO667).
A202) Haase VH, Khawaja Z, Chan J, Zuraw Q, Farzaneh-Far R, Maroni BJ, McCullough PA.
Vadadustat Maintains Hemoglobin (Hb) Levels in Dialysis-Dependent Chronic Kidney Disease
(DD-CKD) Patients Independent of Systemic Inflammation or prior Dose of Erythropoiesis-
Stimulating Agent (ESA). J Am Soc Nephrol 27: 2016 (TH-PO960).
A203) Bottiglieri T, Vasudevan A, Lopez LR, Swift C, Schiffmann R, McCullough P. Increased F2-
Isoprostane Oxidative Stress in Coronary Artery Disease (CAD) Patients with Poor Aspirin-
Induced Thromboxane A2 Inhibition. 84th European Atherosclerosis Society (EAS) Congress,
Innsbruck, Austria, May 29-June 1, 2016.
A204) Winkelmayer W, Block G, Chertow G, Fishbane S, Komatsu Y, McCullough P, Pergola P,
Rosenberger C, Williamson D, Yee J, Collins A, Khawaya Z, Sharma A, Zuraw Q, Maroni B. The
INNO2VATE Phase 3 Program of Vadadustat for Treatment of Anemia in Dialysis-Dependent
CKD: Rationale and Study Design. Poster 173. NKF Spring Clinical Meetings, 2017.
A205) Lopez LR, Vasudevan A, Sathyamoorthy M, Schussler JM, Velasco C, Swift C, Schiffmann R,
Bottiglieri T, McCullough, PA. Relationship of platelet thromboxane inhibition by aspirin and all-
cause mortality in patients with stable coronary artery disease. 85th European Atherosclerosis
Society (EAS) Congress, SAG007, pg 90, Prague, Czech Republic, April 24-26, 2017
A206) Oudiz RJ, Meyer C, Chin M, Feldman J, Goldsberry A, McConnel JWl, McCullough PA, O'Grady
M, Tapson VF, Torres F, Waxman A, White J. Results of Interim Analysis of the Efficacy and
Safety of Bardoxolone Methyl in Patients with Pulmonary Arterial Hypertension Associated with
Connective Tissue Disease (CTD) (The LARIAT Study) American Journal of Respiratory and Critical
Care Medicine 2017;195:A6896 http://www.atsjournals.org/doi/abs/10.1164/ajrccm-
conference.2017.195.1_MeetingAbstracts.A6896
A207) McCullough PA, Weir MR, deGoma EM, Zuraw Q, Sharma A, Luo W, Middleton J.
Vadadustat does not prolong corrected QT interval in a thorough QTC study in healthy subjects.
MP418. 54th ERA-EDTA Congress, Madrid, Spain, June 3-6, 2017. www.era-edta2017.org
A208) Meyer C, Warnock D, Chin M, Goldsberry A, McCullough P, O'Grady M, Toto R, Ward K, Block
G, Pergola P. MP142 A Phase 2/3 Study of the Efficacy and Safety of Bardoxolone Methyl in
Patients with Alport Syndrome. Nephrology Dialysis Transplantation, Volume 32, Issue suppl_3,
1 May 2017, Pages iii480.
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A209) McCullough PA, Uhlig K, Neylan JF, Fishbane S. Safety and Efficacy of Ferric Citrate in
Patients with Nondialysis-Dependent Chronic Kidney Disease and Iron Deficiency Anemia: Post
Hoc Analysis in Patients with or Without Heart Failure. Journal of Cardiac Failure, August 2017,
Volume 23, Issue 8, Supplement, Pages S64–S65.
A210) McCullough PA, David G, Todoran T, Brilakis ES, Ryan MP, Gunnarsson C. Iso-Osmolar
Contrast Media and Adverse Renal and Cardiac Events after Percutaneous Cardiovascular
Intervention. Poster accepted for presentation at ISPOR 20th Annual European Congress,
November 4-8, 2017, Glasgow, Scotland, Value in Health, 2017.
A211) Fried L, Emanuele N, Huang Y, Zhang JH, Palevsky PM, Johnson GR, Seliger SL, McCullough
PA, Conner TA, Brophy M. ESRD and Mortality after VA NEPHRON-D. American Society of
Nephrology Kidney Week 2017, November 1-5, 2017, New Orleans, LA, ABSTRACT: TH-PO717
A212) Block GA, Pergola PE, Inker L, McCullough PA, Chin M, Meyer CH, Rheault MN, Kashtan C,
Warnock DG. Initial Data Report from “CARDINAL”: A Phase 2/3 Study of Bardoxolone Methyl in
Patients with Alport Syndrome. American Society of Nephrology Kidney Week 2017, November
1-5, 2017, New Orleans, LA, ABSTRACT: FR-PO1053
A213) Fishbane S, Adler SH, Singh B, Lavin PT, McCullough PA, Kosiborod M, Pergola PE, Packham
DK, Roger SD, Lerma EV, Butler J, Von haehling S, Spinowitz BS, Block GA. Maintained Efficacy
and Safety of Sodium Zirconium Cyclosilicate for Hyperkalemia: 12-Month, Open-Label, Phase 3
Study, American Society of Nephrology Kidney Week 2017, November 1-5, 2017, New Orleans,
LA, ABSTRACT: TH-PO1112
A214) Packham DK, McCullough PA, Kosiborod M, Spinowitz BS, Fishbane S, Pergola PE, Lerma EV,
Butler J, Von haehling S, Adler SH, Singh B, Lavin PT. Efficacy and Safety of Short-Term
Treatment with Sodium Zirconium Cyclosilicate (ZS-9) for Hyperkalemia: Open-Label, Phase 3
Trial. American Society of Nephrology Kidney Week 2017, November 1-5, 2017, New Orleans,
LA, ABSTRACT: FR-PO1074
A215) McCullough PA, Pergola P, Fishbane S, von Haehling S, Roger S, Adler S, Singh B, Lavin P,
Butler J, Block G, Lerma E, Packham D, Kosiborod M. Efficacy and Safety of Sodium Zirconium
Cyclosilicate to Treat Hyperkalemia Among Patients Taking Renin–Angiotensin–Aldosterone
System Inhibitors in a 12-Month, Open-Label, Phase 3 Study: A Post Hoc Subgroup Analysis.
Circulation. 2017;136:A16610
A216) Ambrosy AP, Mulder H, Coles A, Krauss WE, Lam CS, McCullough PA, Pina I, Tromp J,
Whellan DJ, O’Connor C, Mentz RJ. Renal Function and Exercise Training in Ambulatory Heart
Failure Patients With a Reduced Ejection Fraction - Findings From the HF-ACTION Randomized
Controlled Trial. Circulation. 2017;136:A17039
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A217) Tecson KM, Kluger AY, DiMario S, Harrison D, McCullough PA. Abstract 131: Recurrent acute
cardiovascular events and statin use. Circ: Cardiovasc Qual Outcomes. 2018;11(Suppl 1):A131 LP
– A131. http://circoutcomes.ahajournals.org/content/11/Suppl_1/A131.abstract.
A218) Roger S, Lavin P, Lerma E, McCullough PA, Butler J, Spinowitz B, von Haehling S, Kosiborod
M, Adler S, Fishbane S, Packham D. Safety and Efficacy of Sodium Zirconium Cyclosilicate for
Long-Term Treatment of Hyperkalaemia in Patients with Chronic Kidney Disease: Results From
an Open-Label, Phase 3 Study. FP071, 55th ERA-EDTA Congress, Copenhagen, Denmark, May 24-
27, 2018
A219) Rossing P, Block GA, Chertow GM, Chin M, Goldsberry A, McCullough PA, Meyer CJ,
Packham D, Spinowitz B, Sprague SM, Warnock DG, Pergola PE. Effect of Bardoxolone Methyl
Treatment on Urinary Albumin in Patients with Type 2 Diabetes and Chronic Kidney Disease –
Post-Hoc Analysis from BEAM and BEACON. FP152, 55th ERA-EDTA Congress, Copenhagen,
Denmark, May 24-27, 2018
A220) Meyer CJ, Chakinala MM, Chin MP, Coyne DW, Feldman J, Goldsberry A, McCullough PA,
O’Grady M, Torres F, Oudiz RJ, Ward K, White RJ. Two-Year Durability of Improvements In eGFR
with Bardoxolone Methyl in Patients with Pulmonary Arterial Hypertension: The LARIAT Study.
FP804, 55th ERA-EDTA Congress, Copenhagen, Denmark, May 24-27, 2018
A221) Barker CM, Van Houten J, Mehta H, Cord D, Gunnarsson, Mollenkopf S, Verta P, McCullough
PA. The Healthcare Burden of Disease Progession in Medicare Patients with Functional Mitral
Regurgitation. J Am Coll Cardiol March 12, 2019, 73 (9 Supplement 1) 1051;
DOI:10.1016/S0735-1097(19)31658-4
A222) Cork DP, Mehta H, Barker CM, Verta P, Gunnarsson C, Ryan MP, Baker ER, Mollenkopf S, Van
Houten J, McCullough PA. The Economic Impact of Mitral Regurgitation, on Medically Managed
Incident Heart Failure. J Am Coll Cardiol March 12, 2019, 73 (9 Supplement 1) 1130;
DOI:10.1016/S0735-1097(19)31737-1
A223) Cork DP, Mehta H, Barker CM, Verta P, Ryan MP, Baker E, Gunnarrson C, Mollenkopf S, Van
Houten J, McCullough PA. The Impact of Mitral Regurgitation on Mortality and Heart Failure
Admissions in Newly Diagnosed Heart Failure. J Am Coll Cardiol March 12, 2019, 73 (9
Supplement 1) 1131; DOI:10.1016/S0735-1097(19)31738-3
A224) McCullough PA, Cork DP, Mehta HS, Barker CM, Gunnarrson C, Ryan M, Mollenkopf S. Van
Houten J, Verta P. Abstract 151: Therapeutic Intensity in Medically Managed Incident Heart
Failure Patients with and without Mitral Regurgitation: A Claims Based Analysis. 4 Apr 2019
https://doi.org/10.1161/hcq.12.suppl_1.151Circulation: Cardiovascular Quality and Outcomes.
2019;12:A151
A225) Van Houten J, Cork D, Mehta H, Barker C, Verta P, Gunnarsson C, Ryan MP, Baker ER,
Mollenkopf S, McCullough PA. Therapeutic Intensity Algorithm is Associations with Annual
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Expenditures in Medically Managed Incident Heart Failure Patients with and without Mitral
Regurgitation. ISPOR (The Professional Society for Health Economics and Outcomes Research)
New Orleans, LA May 21, 2019 (top 10% award winner).
A226) Barker C, Cork D, McCullough P, Mehta H, Van Houten J, Gunnarsson C, Mollenkopf S, Verta
P. Survival in Clinically Significant Tricuspid Regurgitation Patients with and without Heart
Failure: Evidence from Optum’s Integrated Databases. J Am Coll Cardiol March 29, 2020, 71 (11
Supplement 1) 1319; DOI:10.1016/S0735-1097(20)31946-X,
https://www.jacc.org/doi/10.1016/S0735-1097%2820%2931946-X
A227) Mehta H, McCullough P, Cork D, Barker C, Van Houten J, Gunnarsson C, Mollenkopf S, Verta
P. Medical Therapy in Patients with Functional Mitral Regurgitation: Are Patients Optimized in
the Real World? J Am Coll Cardiol March 29, 2020, 71 (11 Supplement 1) 1322;
DOI:10.1016/S0735-1097(20)31949-5. https://www.jacc.org/doi/10.1016/S0735-
1097%2820%2931949-5
A228) McCullough PA, Mehta H, Barker C, Van Houten J, Mollenkopf S, Gunnarsson C, Ryan M,
Cork D. Mortality and Guideline Directed Medical Therapy in Heart Failure Patients with
Reduced Ejection Fraction: Evidence from Real World Data. J Am Coll Cardiol May 15, 2021, 77
(18_Supplement_1) 670; DOI: 10.1016/S0735-1097(21)02029-
https://www.jacc.org/doi/full/10.1016/S0735-1097%2821%2902029-5
A229) Tecson KM, Kluger AY, Cassidy-Bushrow AE, Liu B, Coleman CM, Jones LK, Jefferson CR,
VanWormer JJ, Xiang P, Habib M, Mues KE, McCullough PA. Early Statin Use and Recurrent
Major Adverse Cardiovascular Events: A Multicenter Study. Lipid Management Best Practices.
2020;14(4): 561. Doi: 10.1016/j.jacl.2020.05.030
A230) Bottiglieri T, Arning E, Tecson KM, McCullough PA. The Plasma Metabolome is Significantly
Altered in Hypercholesterolemia. Circ Res. 2020;127(12): e272-e284. Doi:
10.1161/RES.0000000000000450
A231) Hamadeh A, Aldujeli A, Briedis K, Tecson KM, Sanchez JS, Al Dujeili M, Al-Obeidi A, Diez-Gil
JL, Zaliunas R, Stoler R, McCullough PA. TCT CONNECT-213 Clinical Characteristics and Outcomes
of Patients With COVID-19 and STEMI Treated With Fibrinolytic Therapy. J Am Coll Cardiol.
2020;76(17):B89–90. doi: 10.1016/j.jacc.2020.09.228.
A232) McCullough PA. (2021) Multifaceted Highly Targeted Sequential Multidrug Treatment of
Early Ambulatory High-Risk SARS-CoV-2 Infection (COVID-19). J Infect Dis Res, 4(S1): 10.
Peer-Reviewed Published Manuscripts
M1)
McCullough PA, O’Neill WW. Influence of Regional Cardiovascular Mortality on the Use of
Angiography after Acute Myocardial Infarction. Am J Cardiol 1997;79:575-80. PMID: 97221465.
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M2)
Stewart RE, Miller DD, Bowers TR, McCullough PA, Ponto RA, Grines CL, O’Neill WW, Juni JE,
Safian RD. PET Perfusion and Vasodilator Function after Angioplasty for Acute Myocardial
Infarction. J Nuc Med 1997;38:770-777. PMID: 97314102.
M3)
Aliabadi D, Pica MC, McCullough PA, Grines CL, Safian RD, O’Neill WW, Goldstein JA. Rapid
Bedside Coronary Angiography with a Portable Fluoroscopic Imaging System. Cathet Cardiovasc
Diagn 1997;41(4):449-455. PMID: 97403128.
M4)
McCullough PA, Wolyn R, Rocher LL, Levin RN, O’Neill WW. Acute Renal Failure after
Coronary Intervention: Incidence, Risk Factors, and Relationship to Mortality. Am J Med
1997;103:368-375. PMID: 98041552.
M5)
Thompson RJ, McCullough PA, Kahn JK, O’Neill WW. Prediction of Death and Neurologic
Outcome in the Emergency Department in Out-of-Hospital Cardiac Arrest Survivors. Am J
Cardiol 1998;81:17-21. PMID: 98122431.
M6)
McCullough PA, Ayad O, O’Neill WW, Goldstein JA. Costs and Outcomes of Patients
Admitted with Chest Pain and Essentially Normal Electrocardiograms. Clin Cardiol 1998;21:22-
26. PMID: 98134803.
M7)
McCullough PA, Smith GS. Evaluation of Narrative Text for Case Finding: The Need for
Accuracy Measurement. Am J Ind Med 1998;34:133-136. PMID: 98315422.
M8)
McCullough PA, Thompson RJ, Tobin KJ, Kahn JK, O’Neill WW. Validation of a Decision
Support Tool for the Evaluation of Cardiac Arrest Victims. Clin Cardiol 1998;21:195-200. PMID:
98202866
M9)
McCullough PA, O’Neill WW, Graham M, Stomel RJ, Rogers F, David S, Farhat A, Kazlauskaite
R, Al-Zagoum M, Grines CL. A Prospective Randomized Trial of Triage Angiography in Acute
Coronary Syndromes Ineligible for Thrombolytic Therapy: Results of the Medicine versus
Angiography in Thrombolytic Exclusion (MATE) Trial. J Am Coll Cardiol 1998;32:596-605. PMID:
98412530.
M10)
Redle JD, Khurana S, Marzan R, McCullough PA, Stewart JR, Westveer DC, O’Neill WW,
Bassett JS, Tepe NA, Frumin HI. Prophylactic Oral Amiodarone Compared to Placebo for
Prevention of Atrial Fibrillation Following Coronary Artery Bypass Surgery. Am Heart J
1999;138:144-150. PMID: 10385778.
M11)
Stevens MA, McCullough PA, Tobin KJ, Speck JP, Westveer DC, Guido-Allen DA, Timmis GC,
O’Neill WW. A Prospective Randomized Trial of Prevention Measures in Patients at High Risk for
Contrast Nephropathy: Results of the P.R.I.N.C.E. Study. J Am Coll Cardiol 1999;33:403-411.
PMID: 99137305.
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M12)
McCullough PA, O'Neill WW. Unstable Angina: Early Use of Coronary Angiography and
Intervention. Cardiol Clin 1999;17(2):373-386. PMID: 10384833.
M13)
McCullough PA, Marks KR. Aspirin and Ticlopidine after Routine Coronary Stenting: The
Gold Standard as of 1999. J Thromb Thrombolysis 1999;7:233-239. PMID: 10373716.
M14)
Sharma ND, McCullough PA, Philbin EF, Weaver WD. Left Ventricular Thrombus and
Subsequent Thromboembolism in Patients with Severe Systolic Dysfunction. Chest
1999;117:314-320. PMID: 10669669.
M15)
McCullough PA, O’Neill WW, Graham M, Stomel RJ, Rogers F, David S, Farhat A, Kazlauskaite
R, Al-Zagoum M, Grines CL. Impaired Culprit Vessel Flow in Acute Coronary Syndromes Ineligible
for Thrombolysis. J Thromb Thrombolysis 2001;10(3):247-253. PMID: 11122545.
M16)
McCullough PA, O’Neill WW, Graham M, Stomel RJ, Rogers F, David S, Farhat A, Kazlauskaite
R, Al-Zagoum M, Grines CL. A Time to Treatment Analysis in the Medicine versus Angiography in
Thrombolytic Exclusion (MATE) Trial. J Interven Cardiol 2001;14(4):415-422. PMID: 12053495.
M17)
McCullough PA, Soman SS, Shah SS, Smith ST, Marks KR, Yee J, Steven Borzak S. Risks
Associated with Renal Dysfunction in Coronary Care Unit Patients. J Am Coll Cardiol
2000;36(3):679-684. PMID: 10987584.
M18)
Philbin EF, McCullough PA, Dec GW, DiSalvo TG. Length of Stay and Procedure Utilization are
the Major Determinants of Hospital Charges for Heart Failure. Clin Cardiol 2001;24:56-62. PMID:
11195608.
M19)
Philbin EF, McCullough PA, DiSalvo TG, Dec GW, Jenkins PL, Weaver WD. Socioeconomic
Status is an Important Determinant of Utilization of Invasive Procedures after Acute Myocardial
Infarction in New York State. Circulation 2000;102[suppl III]:III107-115. PMID: 11082372
M20)
Stone GW, Tumlin JA, Madyoon H, Lepor NE, McCullough PA, Mathur VS, Murray PT, O’Neill
WW. Design and Rationale of CONTRAST--A Prospective, Randomized, Placebo-Controlled Trial
of Fenoldopam Mesylate for the Prevention of Radiocontrast Nephropathy. Rev Cardiovasc
Med. 2001;2 Suppl 1:S31-6. PMID: 12439366.
M21)
Philbin EF, McCullough PA, DiSalvo TG, Dec GW, Jenkins PL, Weaver WD. Underuse of
invasive
procedures
among
Medicaid
patients
with
acute
myocardial
infarction.
Am J Public Health. 2001 Jul;91(7):1082-8. PMID: 11441735
M22)
Bonifacio D, Malineni K, Kadakia R, Soman S, Sandberg K, McCullough PA. Coronary
Calcification and Interventional Outcomes in Dialysis Patients. J Cardiovasc Risk 2001;8(3):133-
7. PMID 11455844
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M23)
Beattie JN, Soman SS, Sandberg KR, Yee J, Borzak S, McCullough PA. Determinants of
Mortality after Myocardial Infarction in Patients with Advanced Renal Dysfunction. Am J Kid
Disease 2001;37:1191-2000. PMID 11382688.
M24)
Cannon CP, Weintraub WS, Demopoulos LA, Vicari R, Frey MJ, Lakkis N, Neumann FJ,
Robertson DH, DeLucca PT, DiBattiste PM, Gibson CM, Braunwald E; TACTICS (Treat Angina with
Aggrastat and Determine Cost of Therapy with an Invasive or Conservative Strategy)--
Thrombolysis in Myocardial Infarction 18 Investigators (McCullough PA, Endpoints Committee).
Comparison of early invasive and conservative strategies in patients with unstable coronary
syndromes treated with the glycoprotein IIb/IIIa inhibitor tirofiban. N Engl J Med. 2001 Jun
21;344(25):1879-87. PMID: 11419424
M25)
Shah SS, Noor H, Tokarski G, McCord J, Khoury N, McCabe KB, Marks KR, Morlock RJ,
McCullough PA. Clinical Effectiveness Evaluation of an Emergency Department Clinical Decision
Unit. British Journal of Clinical Governance 2001;6(1):40-45.
M26)
Cheitlin MD, Gerstenblith G, Hazzard WR, Pasternak R, Fried LP, Rich MW, Krumholz HM,
Peterson E, Reves JG, McKay C, Saksena S, Shen WK, Akhtar M, Brass LM, Biller J. (McCullough
PA, Heart Failure Subcommittee). AHA Conference Proceedings: Do existing databases hold the
answers to clinical questions in geriatric cardiovascular disease and stroke? Executive Summary.
Database Conference, January 27-30, 2000. Circulation. 2001 Aug 14;104(7):E39. PMID:
11502721.
M27)
McCord J, Nowak RM, McCullough PA, Foreback C, Borzak S, Tokarski G, Tomlanovich MC,
Jacobsen G, Weaver WD. Ninety Minute Exclusion of Acute Myocardial Infarction Using
Quantitative Point of Care Testing of Myoglobin and Troponin I. Circulation 2001; Sep
25;104(13):1483-8. PMID: 11571240.
M28)
McCullough PA, Manley HJ. Prediction and Prevention of Contrast Nephropathy. J Interven
Cardiol 2001;14(5):547-558. PMID: 12053647.
M29)
McCullough PA, Philbin EF, Spertus JA, Kaatz S, Sandberg KR, Weaver WD. Confirmation of a
Heart Failure Epidemic: Findings from the Resource Utilization Among Congestive Heart Failure
(R.E.A.C.H.) Study. J Am Coll Cardiol 2002;39:60-69. PMID: 11755288.
M30)
Riaz K, Forker AD, Garg M, McCullough PA. Atypical presentation of cocaine-induced Type A
aortic dissection: a diagnosis made by transesophageal echocardiography. J Investig Med. 2002
Mar;50(2):140-2. PMID 11928942.
M31)
Levin A, Stevens L, McCullough PA. Cardiovascular disease and the kidney. Tracking a killer
in chronic kidney disease. Postgraduate Medicine 2002;11(4):53-60. PMID 11985133.
M32)
Ketterer MW, Denollet J, Goldberg AD, McCullough PA, John S, Farha AJ, Clark V, Keteyian S,
Chapp J, Thayer B, Deveshwar S. The Big Mush: Psychometric Measures are Confounded and
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Nonindependent in Their Association with Age at Initial Diagnosis of Ischemic Coronary Heart
Disease. J Cardiovasc Risk 2002:9;41-48. PMID 11984216.
M33)
Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M,
Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P,
Messenger J; MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation
(McCullough PA, Site Principal Investigator). Cardiac resynchronization in chronic heart failure.
N Engl J Med. 2002 Jun 13;346(24):1845-53. PMID 12063368.
M34)
McCullough PA. Outcomes studies and the biomedical research enterprise.
J Interv Cardiol. 2002 Apr;15(2):167-70. PMID 12063813.
M35)
Shenkman HJ, Pampati V, Khandelwal AK, McKinnon J, Nori D, Kaatz S, Sandberg KR,
McCullough PA. Congestive Heart Failure and QRS Duration: Establishing Prognosis Study.
Chest 2002 Aug;122(2):528-34. PMID 12171827.
M36)
Soman SS, Sandberg KR, Borzak S, Hudson MP, Yee J, McCullough PA. The Independent
Association of Renal Dysfunction and Arrhythmias in Critically Ill Patients. Chest 2002
Aug;122(2):669-77. PMID 12171849.
M37)
Maisel AS, Krishnaswamy P, Nowak RM, McCord J, Hollander JE, Duc P, Omland T, Storrow
AB, Abraham WT, Wu AHB, Clopton P, McCullough PA, for the BNP Multinational Study
Investigators. Bedside B-type Natriuretic Peptide in the Emergency Diagnosis of Heart Failure:
Primary Results from the Breathing Not Properly (BNP) Multinational Study. N Engl J Med,
2002:347(3);161-167. PMID 12124404.
M38)
McCullough PA, Sullivan R. News and Views: Equipoise on Opening Chronic Total
Occlusions. J Interven Cardiol 2002;15(3):243-247. PMID 12141153.
M39)
McCullough PA, Sandberg KR, Borzak S, Hudson MP, Garg M, Manley HJ. Benefits of aspirin
and beta-blockade after myocardial infarction in patients with chronic kidney disease.
Am Heart J. 2002 Aug;144(2):226-32. PMID 12177638.
M40)
McCullough PA, Nowak RM, McCord J, Hollander JE, Herrman HC, Steg PG, Duc P, Westheim
A, Omland T, Wold Knudsen C, Storrow AB, Abraham WT, Lamba S, Wu AHB, Perez A, Clopton P,
Krishnaswamy P, Kazanegra R, Maisel AS, for the BNP Multinational Study Investigators. B-type
Natriuretic Peptide and Clinical Judgment in the Emergency Diagnosis of Heart Failure: An
Analysis from the Breathing Not Properly (BNP) Multinational Study. Circulation 2002;106:416-
422. PMID 12135939.
M41)
McCullough PA, Nowak RM, Foreback C, Borzak S, Tokarski G, Tomlanovich MC, Weaver WD,
Sandberg KR, McCord J. Emergency evaluation of chest pain in patients with advanced kidney
disease. Arch Intern Med. 2002 Nov 25;162(21):2464-8. PMID 12437406.
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M42)
Guitterez N, Diaz A, Timmis GC, O’Neill WW, Stevens MA, McCullough PA. Determinants of
serum creatinine trajectory in acute contrast nephropathy. J Interv Cardiol. 2002 Oct;15(5):349-
54. PMID: 12440177.
M43)
McCullough PA, Prakash R, Tobin KJ, O'Neill WW, Thompson RJ. Application of a cardiac
arrest score in patients with sudden death and ST segment elevation for triage to angiography
and intervention. J Interv Cardiol. 2002 Aug;15(4):257-61. PMID 12238419.
M44)
Reddy HK, Koshy SK, Sturek M, Jayam VK, Bedi A, McCullough PA. Rationale and methods
for assessment of coronary flow prior to coronary intervention: where are we headed?
J Interv Cardiol. 2002 Aug;15(4):335-41. PMID 12238433.
M45)
Sengstock D, Pasnoori V, Obaidat O, Mehra P, Marks KR, McCullough PA. Asthma, Beta-
Agonists, and the Development of Congestive Heart Failure: Results of the A.B.C.H.F. Study. J
Card Failure, 2002;8(4):232-238. PMID 12397571.
M46)
Sullivan R, McCullough PA. Shifting statins from clinic to critical care.
J Interv Cardiol. 2002 Oct;15(5):431-4. PMID 12440192.
M47)
McCullough PA. Cardiorenal Risk: An Important Clinical Intersection. Rev Cardiovasc Med.
2002;3(2):71-76. PMID 12447150
M48)
McCullough PA, Nowak RM, Foreback C, Borzak S, Tokarski G, Tomlanovich MC, Khoury NE,
Weaver WD, Sandberg KR, McCord J. Performance of Multiple Cardiac Biomarkers Measured in
the Emergency Department in Patients with Chronic Kidney Disease and Chest Pain.
Acad Emerg Med. 2002 Dec;9(12):1389-1396. PMID 12460842
M49)
McCullough PA. Scope of cardiovascular complications in patients with kidney disease.
Ethn Dis. 2002 Fall;12(4):S3-44-8. PMID 12477154
M50)
Safley DM, McCullough PA. Antiphospholipid syndrome with renal artery embolism: case
report. Rev Cardiovasc Med. 2002 Fall;3(4):192-201. PMID: 12556753
M51)
McCullough PA, Sandberg KR, Yee J, Hudson MP. Mortality benefit of angiotensin-
converting enzyme inhibitors after cardiac events in patients with end-stage renal disease.
J Renin Angiotensin Aldosterone Syst. 2002 Sep;3(3):188-91. PMID: 12563570
M52)
McCullough PA. Beyond serum creatinine: defining the patient with renal insufficiency and
why? Rev Cardiovasc Med 2003;4(Suppl 1):S2-S6. PMID 12556731
M53)
Riaz K, Forker AD, Isley WL, Hamburg MS, McCullough PA. Hyperthyroidism: a curable
cause of congestive heart failure-three case reports and a review of the literature. Congest
Heart Fail. 2003 Jan-Feb;9(1):40-6. PMID 12556677
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M54)
McCullough PA, Philbin EF, Spertus JA, Sandberg KR, Sullivan RA, Kaatz S. Opportunities for
improvement in the diagnosis and treatment of heart failure.
Clin Cardiol. 2003 May;26(5):231-7. PMID 12769251
M55)
Maisel AS, DeMaria A, Krishnaswamy P, Nowak RM, McCord J, Hollander JE, Duc P, Omland
T, Storrow AB, Abraham WT, Wu AHB, Clopton P, McCullough PA, for the BNP Multinational
Study Investigators. Bedside B-Type natriuretic peptide in the emergency diagnosis of heart
failure with reduced or preserved ejection fraction. Results from the Breathing Not Properly
Multinational Study. J Am Coll Cardiol. 2003 Jun 4;41(11):2010-7.
PMID 12798574
M56)
McCullough PA, Duc P, Omland T, McCord J, Nowak RM, Hollander JE, Herrmann HC, Steg
PG, Westheim A, Knudsen CW, Storrow AB, Abraham WT, Lamba S, Wu AH, Perez A, Clopton P,
Krishnaswamy P, Kazanegra R, Maisel AS; Breathing Not Properly Multinational Study
Investigators. B-type natriuretic peptide and renal function in the diagnosis of heart failure: an
analysis from the Breathing Not Properly Multinational Study.
Am J Kidney Dis. 2003 Mar;41(3):571-9. PMID 12612980
M57)
McCullough PA, Hollander JE, Nowak RM, Storrow AB, Duc P, Omland T, McCord J, Hermann
HC, Steg PG, Westheim A, Knudsen CW, Abraham WT, Lamba S, Wu AHB, Perez A, Clopton P,
Krishnaswamy P, Kazanegra R, Maisel AS, for the BNP Multinational Study Investigators.
Uncovering Heart Failure in Patients with a History of Pulmonary Disease: Rationale for the Early
Use of B-type Natriuretic Peptide in the Emergency Department.
Acad Emerg Med. 2003 Mar;10(3):198-204. PMID 12615582
M58)
McCullough PA. Why is chronic kidney disease the "spoiler" for cardiovascular outcomes? J
Am Coll Cardiol. 2003 Mar 5;41(5):725-8. PMID 12628713
M59)
Riaz K, McCullough PA. Fatal case of delayed repolarization due to cocaine abuse and global
ischemia. Rev Cardiovasc Med. 2003 Winter;4(1):47-53. PMID 12684601
M60)
Safley DM, McCullough PA. The Emerging Role of Brain Natriuretic Peptide in the
Management of Acute and Chronic Heart Failure in Outpatients. Heart Fail Monit. 2003;4(1):13-
20. PMID 12808480
M61)
McCullough PA, Philbin EF, Spertus JA, Sandberg KR, Kaatz S. Angiotensin converting
enzyme inhibitors and beta-blockers in African Americans with heart failure. Ethn Dis. 2003
Summer;13(3):331-6. PMID 12894957.
M62)
McCullough PA. Acute coronary syndromes in patients with renal failure.
Curr Cardiol Rep. 2003 Jul;5(4):266-70. PMID 12801443
M63)
McCullough PA. B-type natriuretic peptides. A diagnostic breakthrough in heart failure.
Minerva Cardioangiol. 2003 Apr;51(2):121-9. PMID 12783068
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M64)
Keeley EC, Kadakia R, Soman S, Borzak S, McCullough PA. Analysis of long-term survival
after revascularization in patients with chronic kidney disease presenting with acute coronary
syndromes. Am J Cardiol. 2003 Sep 1;92(5):509-14. PMID 12943868.
M65)
McCullough PA, Omland T, Maisel AS. B-type natriuretic peptides: a diagnostic
breakthrough for clinicians. Rev Cardiovasc Med. 2003 Spring;4(2):72-80.
PMID 12776016
M66)
McCullough PA, Abraham WT. Does Quality of Life Evidence Assist in the Selection of
Patients for Resynchronization Therapy? Card Electrophysiol Rev. 2003 Jan;7(1):71-76.
PMID 12766523
M67)
Chew DP, Bhatt DL, Kimball W, Henry TD, Berger P, McCullough PA, Feit F, Bittl JA, Lincoff
AM. Bivalirudin provides increasing benefit with decreasing renal function: a meta-analysis of
randomized trials. Am J Cardiol. 2003 Oct 15;92(8):919-23. PMID 14556866
M68)
Maisel AS, McCullough PA. Cardiac natriuretic peptides: a proteomic window to cardiac
function and clinical management. Rev Cardiovasc Med. 2003;4 Suppl 4:S3-S12. PMID
14564223
M69)
McCullough PA, Sandberg KR. Sorting out the evidence on natriuretic peptides. Rev
Cardiovasc Med. 2003;4 Suppl 4:S13-9. PMID 14564224
M70)
McCullough PA, Sandberg KR. B-type natriuretic peptide and renal disease. Heart Fail Rev.
2003 Oct;8(4):355-8. PMID 14574057
M71)
Keeley EC, McCullough PA. Coronary revascularization in patients with end-stage renal
disease: risks, benefits, and optimal strategies. Rev Cardiovasc Med. 2003 Summer;4(3):125-30.
PMID 12949440.
M72)
McCord J, Nowak RM, Hudson MP, McCullough PA, Tomlanovich MC, Jacobsen G, Tokarski
G, Khoury N, Weaver WD. The prognostic significance of serial myoglobin, troponin I, and
creatine kinase-MB measurements in patients evaluated in the emergency department for acute
coronary syndrome. Ann Emerg Med. 2003 Sep;42(3):343-50. PMID 12944886.
M73)
Sarnak MJ, Levey AS, Schoolwerth AC, Coresh J, Culleton B, Hamm LL, McCullough PA,
Kasiske BL, Kelepouris E, Klag MJ, Parfrey P, Pfeffer M, Raij L, Spinosa DJ, Wilson PW; AHA
Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology,
and Epidemiology and Prevention. Kidney disease as a risk factor for development of
cardiovascular disease: a statement from the AHA Councils on Kidney in Cardiovascular Disease,
High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention.
Circulation. 2003 Oct 28;108(17):2154-69. PMID 14581387.
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M74)
Sarnak MJ, Levey AS, Schoolwerth AC, Coresh J, Culleton B, Hamm LL, McCullough PA,
Kasiske BL, Kelepouris E, Klag MJ, Parfrey P, Pfeffer M, Raij L, Spinosa DJ, Wilson PW; AHA
Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology,
and Epidemiology and Prevention. Kidney disease as a risk factor for development of
cardiovascular disease: a statement from the AHA Councils on Kidney in Cardiovascular Disease,
High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention.
Hypertension. 2003 Nov;42(5):1050-65. PMID 14604997.
M75)
Stone GW, McCullough PA, Tumlin JA, Lepor NE, Madyoon H, Murray P, Wang A, Chu AA,
Schaer GL, Stevens M, Wilensky RL, O'Neill WW; CONTRAST Investigators. Fenoldopam
mesylate for the prevention of contrast-induced nephropathy: a randomized controlled trial.
JAMA. 2003 Nov 5;290(17):2284-91. PMID 14600187.
M76)
Steg PG, Duc P, Joubin L, McCord J, Abraham WT, Hollander JE, Omland T, Baron G, Aumont
MC, Mentre F, McCullough PA, Maisel AS. A comparison of bedside B-type natriuretic peptide
versus echocardiographic determination of ejection fraction in the diagnosis of heart failure. J
Am Coll Cardiol. 2003 Mar 19;41(6 Suppl B):337. PMID 14637402
M77)
Kernis SJ, Franklin BA, Sandberg KR, O'Neill WW, McCullough PA. Advantages of an early
invasive approach in acute coronary syndromes. Am J Med. 2003 Dec 1;115(8):669-71. PMID
14656622
M78)
McCullough PA, Sandberg KR. Epidemiology of contrast-induced nephropathy.
Rev Cardiovasc Med. 2003;4 Suppl 5:S3-9. PMID 14668704
M79)
Khanna A, McCullough PA. Malignant hypertension presenting as hemolysis,
thrombocytopenia, and renal failure. Rev Cardiovasc Med. 2003 Fall;4(4):255-9. PMID
14674379
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McCullough PA, Fonarow GC. B-type natriuretic peptide and multimarker approaches in
cardiovascular medicine. Rev Cardiovasc Med. 2003;4 Suppl 4:S1-2. PMID 14703686
M81)
McCullough PA, Kuncheria J, Mathur VS. Diagnostic and therapeutic utility of B-type
natriuretic peptide in patients with renal insufficiency and decompensated heart failure. Rev
Cardiovasc Med. 2003;4 Suppl 7:S3-S12. PMID 14668695
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Franklin BA, McCullough PA, Gordon S. Winter Storm Warning: Snow Removal May Be
Hazardous to Your (Patient's) Health. Curr Sports Med Rep. 2004 Apr;3(2):59-61. PMID
14980132
M83)
Conaway DG, Sullivan RA, McCullough PA. Improved Symptoms, Physical Limitation, and
Self-Efficacy After Resynchronization in a Patient with Heart Failure and a Prolonged QRS
Duration. Rev Cardiovasc Med. 2004 Winter;5(1):53-7. PMID 15029112
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M84)
McCullough PA, Sandberg KR Chronic kidney disease and sudden death: strategies for
prevention. Blood Purif. 2004;22(1):136-42. PMID 14732822
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Knudsen, CW, Omland, T, Clopton P, Westheim, A, Abraham, WT, Storrow AB, J McCord,
Nowak, RM, Steg, PG, Duc, P, McCullough, PA, Maisel, AS, for the BNP Multinational Study
Investigators. Diagnostic Value of B-type Natriuretic Peptide and Chest Radiograph Findings in
Patients with Acute Dyspnea. Am J Med. 2004 Mar 15;116(6):363-8. PMID 15006584
M86)
McCullough PA, Gibson CM, Dibattiste PM, Demopoulos LA, Murphy SA, Weintraub WS,
Neumann FJ, Khanal S, Cannon CP; TACTICS-TIMI-18 INVESTIGATORS. Timing of Angiography
and Revascularization in Acute Coronary Syndromes: J Interv Cardiol. 2004 Apr;17(2):81-86.
PMID 15104769.
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McCullough PA. B-type natriuretic peptide and its clinical implications in heart failure. Am
Heart Hosp J 2004;2:26-33.
M88)
McCullough PA, Dorrell KA, Sandberg KR, Yerkey MW. Ximelagatran: a novel oral direct
thrombin inhibitor for long-term anticoagulation. Rev Cardiovasc Med. 2004 Spring;5(2):99-103.
PMID 15184843.
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Maisel AS, Clopton P, Krishnaswamy P, Nowak RM, McCord J, Hollander JE, Duc P, Omland T,
Storrow AB, Abraham WT, Wu AH, Steg G, Westheim A, Knudsen CW, Perez A, Kazanegra R,
Bhalla V, Herrmann HC, Aumont MC, McCullough PA; BNP Multinational Study Investigators.
Impact of age, race, and sex on the ability of B-type natriuretic peptide to aid in the emergency
diagnosis of heart failure: results from the Breathing Not Properly (BNP) multinational study.
Am Heart J. 2004 Jun;147(6):1078-84. PMID 15199359.
M90)
McCullough PA. Cardiovascular risk reduction and preservation of renal function in the early
nephropathy patient. Adv Chronic Kidney Dis. 2004 Apr;11(2):184-91. PMID 15216489.
M91)
Yerkey MW, Kernis SJ, Franklin BA, Sandberg KR, McCullough PA. Renal dysfunction and
acceleration of coronary disease. Heart. 2004 Aug;90(8):961-6. PMID 15253986
M92)
McCullough PA, Soman S. Cardiovascular calcification in patients with chronic renal failure:
Are we on target with this risk factor? Kidney Int. 2004 Sep;66 Suppl 90:S18-24. PMID
15296503
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McCullough PA, Sandberg KR, Dumler F, Yanez JE. Determinants of coronary vascular
calcification in patients with chronic kidney disease and end-stage renal disease: a systematic
review. J Nephrol. 2004 Mar-Apr;17(2):205-15. PMID 15293519
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McCullough PA. Opportunities for improvement in the cardiovascular care of patients with
end-stage renal disease. Adv Chronic Kidney Dis. 2004 Jul;11(3):294-303. PMID 15241743
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M95)
Dumler F, McCullough PA. Optimal dialysis for the end-stage renal disease patient with
cardiovascular disease. Adv Chronic Kidney Dis. 2004 Jul;11(3):261-73. PMID 15241741
M96)
Keeley EC, McCullough PA. Coronary revascularization in patients with coronary artery
disease and chronic kidney disease. Adv Chronic Kidney Dis. 2004 Jul;11(3):254-60. PMID
15241740
M97)
McCullough PA. Guest editorial: Cardiovascular care in end-stage renal disease. Adv
Chronic Kidney Dis. 2004 Jul;11(3):245. PMID 15241738
M98)
McCullough PA, Bakris GL, Owen WF Jr, Klassen PS, Califf RM. Slowing the progression of
diabetic nephropathy and its cardiovascular consequences. Am Heart J. 2004 Aug;148(2):243-
51. PMID 15308993
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Best PJ, Reddan DN, Berger PB, Szczech LA, McCullough PA, Califf RM. Cardiovascular
disease and chronic kidney disease: insights and an update. Am Heart J. 2004 Aug;148(2):230-
42. PMID 15308992
M100) Bakris GL, Toto RD, McCullough PA. Rationale and design of a study comparing two fixed-
dose combination regimens to reduce albuminuria in patients with type II diabetes and
hypertension. J Hum Hypertens. 2004 Sep 30 PMID 15457206.
M101) Wu AH, Omland T, Duc P, McCord J, Nowak RM, Hollander JE, Herrmann HC, Steg PG, Wold
Knudsen C, Storrow AB, Abraham WT, Perez A, Kamin R, Clopton P, Maisel AS, McCullough PA.
Breathing Not Properly Multinational Study Investigators. The effect of diabetes on B-type
natriuretic peptide concentrations in patients with acute dyspnea: an analysis from the
Breathing Not Properly Multinational Study. Diabetes Care. 2004 Oct;27(10):2398-404. PMID
15451907
M102) McCullough PA, Franklin BA. Conventional risk factors and cardiac events--debunking an old
myth about prevalence. Rev Cardiovasc Med. 2004 Summer;5(3):185-6. PMID 15346104
M103) Maisel A, Hollander JE, Guss D, McCullough P, Nowak R, Green G, Saltzberg M, Ellison SR,
Bhalla MA, Bhalla V, Clopton P, Jesse R; Rapid Emergency Department Heart Failure Outpatient
Trial investigators. Primary results of the Rapid Emergency Department Heart Failure Outpatient
Trial (REDHOT): a multicenter study of B-type natriuretic peptide levels, emergency department
decision making, and outcomes in patients presenting with shortness of breath. J Am Coll
Cardiol. 2004 Sep 15;44(6):1328-33. PMID 15364340
M104) McCullough PA. Cardiovascular disease in chronic kidney disease from a cardiologist's
perspective. Curr Opin Nephrol Hypertens. 2004 Nov;13(6):591-600. PMID: 15483448
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M105) McCord J, Mundy BJ, Hudson MP, Maisel AS, Hollander JE, Abraham WT, Steg PG, Omland T,
Knudsen CW, Sandberg KR, McCullough PA. Relationship between obesity and B-type
natriuretic Peptide levels. Arch Intern Med. 2004 Nov 8;164(20):2247-52. PMID: 15534162
M106) Wase A, Basit A, Nazir R, Jamal A, Shah S, Khan T, Mohiuddin I, White C, Saklayen M,
McCullough PA. Impact of chronic kidney disease upon survival among implantable
cardioverter-defibrillator recipients. J Interv Card Electrophysiol. 2004 Dec;11(3):199-204.
PMID: 15548886
M107) McCullough PA. B-type natriuretic peptide and its clinical implications in heart failure. Am
Heart Hosp J. 2004 Winter;2(1):26-33. PMID: 15604836
M108) Silver MA, Maisel A, Yancy CW, McCullough PA, Burnett JC Jr., Francis GS, Mehra MR,
Peacock WF 4th, Fonarow G, Gibler WB, Morrow DA, Hollander J; BNP Consensus Panel. BNP
Consensus Panel 2004: A clinical approach for the diagnostic, prognostic, screening, treatment
monitoring, and therapeutic roles of natriuretic peptides in cardiovascular diseases. Congest
Heart Fail. 2004 Sep-Oct;10(5 Suppl 3):1-30. PMID: 15604859
M109) McCullough PA. Preface. Ximelagatran and oral direct thrombin inhibition. Rev Cardiovasc
Med. 2004;5 Suppl 5:S1. PMID: 15619609
M110) Prystowsky EN, McCullough PA. Introduction: the role of oral direct thrombin inhibitors in
cardiovascular disease. Rev Cardiovasc Med. 2004;5 Suppl 5:S2-3. PMID: 15619611
M111) McCullough PA. Clinical applications of B-type natriuretic peptide levels in the care of
cardiovascular patients. Minerva Cardioangiol. 2004 Dec;52(6):479-89. PMID: 15729209
M112) Safley DM, Awad A, Sullivan RA, Sandberg KR, Mourad I, Boulware M, Merhi W, McCullough
PA. Changes in B-type natriuretic peptide levels in hemodialysis and the effect of depressed left
ventricular function. Adv Chronic Kidney Dis. 2005 Jan;12(1):117-24. PMID: 15719344.
M113) McCullough PA, Khandelwal AK, McKinnon JE, Shenkman HJ, Pampati V, Nori D, Sullivan RA,
Sandberg KR, Kaatz S. Outcomes and prognostic factors of systolic as compared with diastolic
heart failure in urban America. Congest Heart Fail. 2005 Jan-Feb;11(1):6-11. PMID: 15722664.
M114) McCullough PA, Lepor NE. The deadly triangle of anemia, renal insufficiency, and
cardiovascular disease: implications for prognosis and treatment. Rev Cardiovasc Med. 2005
Winter;6(1):1-10. PMID: 15741920
M115) El-Achkar TM, Ohmit SE, McCullough PA, Crook ED, Brown WW, Grimm R, Bakris GL, Keane
WF, Flack JM. Higher prevalence of anemia with diabetes mellitus in moderate kidney
insufficiency: The Kidney Early Evaluation Program. Kidney Int. 2005 Apr;67(4):1483-8. PMID:
15780101
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M116) McCullough PA, Soman SS. Contrast-induced nephropathy. Crit Care Clin. 2005
Apr;21(2):261-80. PMID: 15781162
M117) McCullough PA. Evaluation and treatment of coronary artery disease in patients with end-
stage renal disease. Kidney Int Suppl. 2005 Jun;(95):s51-8. PMID: 15882314
M118) Knudsen CW, Clopton P, Westheim A, Klemsdal TO, Wu AH, Duc P, McCord J, Nowak RM,
Hollander JE, Storrow AB, Abraham WT, McCullough PA, Maisel AS, Omland T. Predictors of
elevated B-type natriuretic peptide concentrations in dyspneic patients without heart failure: an
analysis from the breathing not properly multinational study. Ann Emerg Med. 2005
Jun;45(6):573-80. PMID: 15940086
M119) Gallagher MJ, Franklin BA, Ehrman JK, Keteyian SJ, Brawner CA, deJong AT, McCullough PA.
Comparative Impact of Morbid Obesity vs Heart Failure on Cardiorespiratory Fitness. Chest.
2005 Jun;127(6):2197-203. PMID: 15947337
M120) Mehta SR, Cannon CP, Fox KA, Wallentin L, Boden WE, Spacek R, Widimsky P, McCullough
PA, Hunt D, Braunwald E, Yusuf S. Routine vs selective invasive strategies in patients with acute
coronary syndromes: a collaborative meta-analysis of randomized trials. JAMA. 2005 Jun
15;293(23):2908-17. PMID: 15956636
M121) Merhi W, Dixon SR, O'Neill WW, Hanzel GS, McCullough PA. Percutaneous left ventricular
assist device in acute myocardial infarction and cardiogenic shock. Rev Cardiovasc Med. 2005
Spring;6(2):118-23. PMID: 15976733
M122) Gallagher MJ, McCullough PA. The role of B-type natriuretic peptide in the diagnosis and
treatment of decompensated heart failure. Int J Geriatric Cardiol 2004; September 1(1):21-28.
M123) McCullough PA, Hassan SA, Pallekonda V, Sandberg KR, Nori DB, Soman SS, Bhatt S, Hudson
MP, Weaver WD. Bundle branch block patterns, age, renal dysfunction, and heart failure
mortality. Int J Cardiol. 2005 Jul 10;102(2):303-8. PMID: 15982501
M124) Steg PG, Joubin L, McCord J, Abraham WT, Hollander JE, Omland T, Mentre F, McCullough
PA, Maisel AS. B-type natriuretic Peptide and echocardiographic determination of ejection
fraction in the diagnosis of congestive heart failure in patients with acute dyspnea. Chest. 2005
Jul;128(1):21-9. PMID 16002911
M125) Gallagher MJ, McCullough PA. The emerging role of natriuretic peptides in the diagnosis
and treatment of decompensated heart failure. Curr Heart Fail Rep. 2004 Sep;1(3):129-35.
PMID: 16036036
M126) McCullough PA, Sandberg KR, Miller WM, Odom JS, Sloan KC, de Jong AT, Nori KE, Irving SD,
Krause KR, Franklin BA. Substantial weight gain during adulthood: the road to bariatric surgery.
Prev Cardiol. 2005 Summer;8(3):155-9. PMID 16034218
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M127) Miller WM, Nori Janosz KE, Yanez J, McCullough PA. Effects of weight loss and
pharmacotherapy on inflammatory markers of cardiovascular disease. Expert Rev Cardiovasc
Ther. 2005 Jul;3(4):743-59. PMID 16076283
M128) Nori Janosz KE, Miller WM, Odom J, Lillystone M, McCullough PA. Optimal diabetes
management during medical weight loss for cardiovascular risk reduction. Expert Rev
Cardiovasc Ther. 2005 Jul;3(4):761-75. PMID 16076284
M129) McCullough PA, Berman AD. Percutaneous coronary interventions in the high-risk renal
patient: strategies for renal protection and vascular protection. Cardiol Clin. 2005
Aug;23(3):299-310. PMID 16084279
M130) Luther SA, McCullough PA, Havranek EP, Rumsfeld JS, Jones PG, Heidenreich PA, Peterson
ED, Rathore SS, Krumholz HM, Weintraub WS, Spertus JA, Masoudi FA; for the Cardiovascular
Outcomes Research Consortium. The Relationship Between B-type Natriuretic Peptide and
Health Status in Patients With Heart Failure. J Card Fail. 2005 Aug;11(6):414-21. PMID
16105631
M131) Knudsen CW, Omland T, Clopton P, Westheim A, Wu AH, Duc P, McCord J, Nowak RM,
Hollander JE, Storrow AB, Abraham WT, McCullough PA, Maisel A. Impact of atrial fibrillation on
the diagnostic performance of B-type natriuretic Peptide concentration in dyspneic patients an
analysis from the breathing not properly multinational study. J Am Coll Cardiol. 2005 Sep
6;46(5):838-44. PMID 16139134
M132) McCullough PA. Chronic angina: new medical options for treatment. Rev Cardiovasc Med.
2005 Summer;6(3):152-61. PMID 16195688
M133) Spertus J, Peterson E, Conard MW, Heidenreich PA, Krumholz HM, Jones P, McCullough PA,
Pina I, Tooley J, Weintraub WS, Rumsfeld JS; Cardiovascular Outcomes Research Consortium.
Monitoring clinical changes in patients with heart failure: a comparison of methods. Am Heart J.
2005 Oct;150(4):707-15. PMID 16209970
M134) McCullough PA. Effect of lipid modification on progression of coronary calcification. J Am
Soc Nephrol. 2005 Nov;16 Suppl 2:S115-9. PMID 16251246
M135) Wu AH, Omland T, Wold Knudsen C, McCord J, Nowak RM, Hollander JE, Duc P, Storrow AB,
Abraham WT, Clopton P, Maisel AS, McCullough PA. For The Breathing Not Properly
Multinational Study Investigators. Relationship of B-type natriuretic peptide and anemia in
patients with and without heart failure: A substudy from the Breathing Not Properly (BNP)
Multinational Study. Am J Hematol. 2005 Oct 24;80(3):174-180. PMID 16247751
M136) Miller WM, Nori-Janosz KE, Lillystone M, Yanez J, McCullough PA. Obesity and lipids. Curr
Cardiol Rep. 2005 Nov;7(6):465-70. PMID 16256017
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M137) McCord J, Nowak RM, Jacobsen G, Sallach JA, Wu AH, Perez A, Omland T, Knudsen CW,
Westheim A, Duc P, Steg PG, Hollander JE, Herrmann HC, Storrow AB, Abraham WT, Lamba S,
McCullough PA, Maisel A. B-Type Natriuretic Peptide Levels in Patients in the Emergency
Department with Possible Heart Failure and Previous Stable Angina Pectoris and/or Healed
Myocardial Infarction. Am J Cardiol. 2005 Nov 15;96(10):1370-3. Epub 2005 Sep 23. PMID
16275180
M138) Chinnaiyan KM, Alexander D, McCullough PA. Role of Angiotensin II in the Evolution of
Diastolic Heart Failure. J Clin Hypertens (Greenwich). 2005 Dec;7(12):740-7. PMID: 16330897
M139) McCullough PA. Symposium: cardiovascular diseases and renal insufficiency. Introduction.
Int J Geriatric Cardiol 2005; September 2005 2(3):130.
M140) McCullough PA. Spectrum of cardiorenal disease. Int J Geriatric Cardiol 2005; September
2005 2(3):131-135.
M141) McCullough PA, Lepor NE. Anemia: A Modifiable Risk Factor for Heart Disease. Rev
Cardiovasc Med. 2005;6 Suppl. 3:1-3. PMID: 16340932
M142) McCullough PA, Lepor NE. Piecing Together the Evidence on Anemia: The Link between
Chronic Kidney Disease and Cardiovascular Disease. Rev Cardiovasc Med. 2005;6 Suppl. 3:4-12.
PMID: 16340933
M143) McCullough PA, Silver MA, Kennard ED, Kelsey SF, Michaels AD; IEPR Investigators. Impact
of body mass index on outcomes of enhanced external counterpulsation therapy. Am Heart J.
2006 Jan;151(1):139. PMID: 16368306
M144) Strunk A, Bhalla V, Clopton P, Nowak RM, McCord J, Hollander JE, Duc P, Storrow AB,
Abraham WT, Wu AHB, Steg G, Perez A, Kazanegra R, Herrmann HC, Aumont MC, McCullough
PA, Maisel A, for the BNP Multinational Study Investigators. Impact of the history of congestive
heart failure on the utility of B-type natriuretic peptide in the emergency diagnosis of heart
failure: Results from the Breathing Not Properly Multinational Study. Am J Med 119(1):69.e1-
69.e11, 2006. PMID: 16431187
M145) McCullough P. Outcomes of contrast-induced nephropathy: Experience in patients
undergoing cardiovascular intervention. Catheter Cardiovasc Interv. 2006 Mar;67(3):335-43.
PMID: 16489569.
M146) McCullough PA, Mueller C, Yancy CW Jr. Overview of B-type natriuretic Peptide as a blood
test. Congest Heart Fail. 2006 Mar-Apr;12(2):99-102. PMID: 16596044
M147) McCullough PA. Ranolazine: Focusing on angina pectoris. Drugs Today (Barc). 2006
Mar;42(3):177-83. PMID: 16628259
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M148) Daniels LB, Clopton P, Bhalla V, Krishnaswamy P, Nowak RM, McCord J, Hollander JE, Duc P,
Omland T, Storrow AB, Abraham WT, Wu AH, Steg PG, Westheim A, Knudsen CW, Perez A,
Kazanegra R, Herrmann HC, McCullough PA, Maisel AS. How obesity affects the cut-points for B-
type natriuretic peptide in the diagnosis of acute heart failure. Results from the Breathing Not
Properly Multinational Study. Am Heart J. 2006 May;151(5):1006-12. PMID: 16644321
M149) Brenden CK, Hollander JE, Guss D, McCullough PA, Nowak R, Green G, Saltzberg M, Ellison
SR, Bhalla MA, Bhalla V, Clopton P, Jesse R, Maisel AS; REDHOT Investigators. Gray zone BNP
levels in heart failure patients in the emergency department: results from the Rapid Emergency
Department Heart Failure Outpatient Trial (REDHOT) multicenter study. Am Heart J. 2006
May;151(5):1013-8. PMID: 16644322
M150) Daniels LB, Bhalla V, Clopton P, Hollander JE, Guss D, McCullough PA, Nowak R, Green G,
Saltzberg M, Ellison SR, Bhalla MA, Jesse R, Maisel A. B-Type Natriuretic Peptide (BNP) Levels
and Ethnic Disparities in Perceived Severity of Heart Failure Results From the Rapid Emergency
Department Heart Failure Outpatient Trial (REDHOT) Multicenter Study of BNP Levels and
Emergency Department Decision Making in Patients Presenting With Shortness of Breath. J Card
Fail. 2006 May;12(4):281-5. PMID: 16679261
M151) Hanzel GS, Downes M, McCullough PA. Editorial: Renal function after renal artery stenting.
J Geriatric Cardiol 2005;2(4):196-197.
M152) Foley RN, McCullough PA. Editorial: Anemia and left ventricular hypertrophy in non-dialysis
chronic kidney disease. J Geriatric Cardiol 2005;2(4):195-196.
M153) McCullough PA. Chronic kidney disease: tipping the scale to the benefit of angiotensin-
converting enzyme inhibitors in patients with coronary artery disease. Circulation. 2006 Jul
4;114(1):6-7. PMID: 16818827
M154) McCullough PA, Gallagher MJ, deJong AT, Sandberg KR, Trivax JE, Alexander D, Kasturi G,
Jafri SM, Krause KR, Chengelis DL, Moy J, Franklin BA. Cardiorespiratory fitness and short-term
complications after bariatric surgery. Chest. 2006 Aug;130(2):517-25. PMID: 16899853
M155) Ochoa AB, DeJong A, Grayson D, Franklin B, McCullough P. Effect of enhanced external
counterpulsation on resting oxygen uptake in patients having previous coronary
revascularization and in healthy volunteers. Am J Cardiol. 2006 Sep 1;98(5):613-5. Epub 2006
Jun 30. PMID: 16923446
M156) McCullough PA, Bertrand ME, Brinker JA, Stacul F. A meta-analysis of the renal safety of
isosmolar iodixanol compared with low-osmolar contrast media. J Am Coll Cardiol. 2006 Aug
15;48(4):692-9. Epub 2006 Jul 24. PMID: 16904536
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M157) McCullough PA, Wase A. Do implantable cardioverter-defibrillators improve survival in
dialysis patients after cardiac arrest? Nat Clin Pract Nephrol. 2006 Feb;2(2):70-1. PMID:
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M158) McCullough PA, Stacul F, Davidson C, Becker CR, Adam A, Lameire N, Tumlin J; CIN
Consensus Working Panel. Overview. Am J Cardiol. 2006 Sep 18;98(6S1):2-4. Epub 2006 Feb 13.
PMID: 16949374.
M159) McCullough PA, Adam A, Becker CR, Davidson C, Lameire N, Stacul F, Tumlin J; CIN
Consensus Working Panel. Epidemiology and Prognostic Implications of Contrast-Induced
Nephropathy. Am J Cardiol. 2006 Sep 18;98(6S1):5-13. Epub 2006 Feb 10. PMID: 16949375
M160) Tumlin J, Stacul F, Adam A, Becker CR, Davidson C, Lameire N, McCullough PA; CIN
Consensus Working Panel. Pathophysiology of Contrast-Induced Nephropathy. Am J Cardiol.
2006 Sep 18;98(6S1):14-20. Epub 2006 Feb 17. PMID: 16949376
M161) Lameire N, Adam A, Becker CR, Davidson C, McCullough PA, Stacul F, Tumlin J; CIN
Consensus Working Panel. Baseline Renal Function Screening. Am J Cardiol. 2006 Sep
18;98(6S1):21-26. Epub 2006 Feb 20. PMID: 16949377
M162) McCullough PA, Adam A, Becker CR, Davidson C, Lameire N, Stacul F, Tumlin J; CIN
Consensus Working Panel. Risk Prediction of Contrast-Induced Nephropathy. Am J Cardiol.
2006 Sep 18;98(6S1):27-36. Epub 2006 Feb 23. PMID: 16949378
M163) Becker CR, Davidson C, Lameire N, McCullough PA, Stacul F, Tumlin J, Adam A; CIN
Consensus Working Panel. High-Risk Situations and Procedures. Am J Cardiol. 2006 Sep
18;98(6S1):37-41. Epub 2006 Feb 20. PMID: 16949379
M164) Davidson C, Stacul F, McCullough PA, Tumlin J, Adam A, Lameire N, Becker CR; CIN
Consensus Working Panel. Contrast Medium Use. Am J Cardiol. 2006 Sep 18;98(6S1):42-58.
Epub 2006 Mar 2. PMID: 16949380
M165) Stacul F, Adam A, Becker CR, Davidson C, Lameire N, McCullough PA, Tumlin J; CIN
Consensus Working Panel. Strategies to Reduce the Risk of Contrast-Induced Nephropathy. Am
J Cardiol. 2006 Sep 18;98(6S1):59-77. Epub 2006 Mar 20. PMID: 16949381
M166) Vanhecke TE, Miller WM, Franklin BA, Weber JE, McCullough PA. Awareness, knowledge,
and perception of heart disease among adolescents. Eur J Cardiovasc Prev Rehabil. 2006
Oct;13(5):718-23. PMID: 17001210
M167) Zalesin KC, McCullough PA. Bariatric surgery for morbid obesity: risks and benefits in
chronic kidney disease patients. Adv Chronic Kidney Dis. 2006 Oct;13(4):403-17. PMID:
17045226
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M168) Michaels AD, McCullough PA, Soran OZ, Lawson WE, Barsness GW, Henry TD, Linnemeier G,
Ochoa A, Kelsey SF, Kennard ED, for the IEPR Investigators. Primer: practical approach to the
selection of patients for and application of EECP. Nature Clinical Practice Cardiovascular
Medicine 2006; 3: 623-632. PMID: 17063167
M169) McCullough PA. Failure of beta-blockers in the reduction of perioperative events: where did
we go wrong? Am Heart J. 2006 Nov;152(5):815-8. PMID: 17070139
M170) McCullough PA. Renal safety of iodixanol. Expert Rev Cardiovasc Ther. 2006 Sep;4(5):655-
61. PMID: 17081087
M171) Vanhecke TE, Franklin BA, Lillystone MA, Sandberg KR, DeJong AT, Krause KR, Chengelis DL,
McCullough PA. Caloric Expenditure in the Morbidly Obese Using Dual Energy X-ray
Absorptiometry. J Clin Densitom. 2006 Oct-Dec;9(4):438-44. Epub 2006 Sep 28. PMID:
17097530
M172) Conard MW, Haddock CK, Poston WS, Havranek E, McCullough P, Spertus J; Cardiovascular
Outcomes Research Consortium. Impact of obesity on the health status of heart failure patients.
J Card Fail. 2006 Dec;12(9):700-6. PMID: 17174231
M173) McCullough PA, Stacul F, Becker CR, Adam A, Lameire N, Tumlin JA, Davidson CJ. Contrast-
Induced Nephropathy (CIN) Consensus Working Panel: Executive Summary. Rev Cardiovasc
Med. 2006 Fall;7(4):177-97. PMID: 17224862
M174) Chinnaiyan KM, Alexander D, Maddens M, McCullough PA. Curriculum in cardiology:
integrated diagnosis and management of diastolic heart failure. Am Heart J. 2007
Feb;153(2):189-200. PMID: 17239676
M175) Vogel JA, Franklin BA, Zalesin KC, Trivax JE, Krause KR, Chengelis DL, McCullough PA.
Reduction in predicted coronary heart disease risk after substantial weight reduction after
bariatric surgery. Am J Cardiol. 2007 Jan 15;99(2):222-6. Epub 2006 Nov 16. PMID: 17223422
M176) McCullough PA, Rocher LR. Statin therapy in renal disease: Harmful or protective. Curr
Atheroscler Rep. 2007 Jan;9(1):18-24. PMID: 17169242
M177) McCullough PA. [Cardiorenal intersection: crossroads to the future.] Arq Bras Cardiol. 2007
Jan;88(1):117-26. Portuguese Translation. PMID: 17364130
M178) Mehta L, Devlin W, McCullough PA, O'Neill WW, Skelding KA, Stone GW, Boura JA, Grines CL.
Impact of body mass index on outcomes after percutaneous coronary intervention in patients
with acute myocardial infarction. Am J Cardiol. 2007 Apr 1;99(7):906-10. Epub 2007 Feb 12.
PMID: 17398181
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M179) McCullough PA. Kidney disease. Estimated glomerular filtration rate: why is it important?
Rev Cardiovasc Med. 2007 Winter;8(1):46-9. PMID: 17401304
M180) Lawson WE, Hui JC, Kennard ED, Soran O, McCullough PA, Kelsey SF; for the IEPR
Investigators. Effect of enhanced external counterpulsation on medically refractory angina
patients with erectile dysfunction. Int J Clin Pract. 2007 May;61(5):757-62. PMID: 17493089
M181) McCullough PA, Jurkovitz CT, Pergola PE, McGill JB, Brown WW, Collins AJ, Chen SC, Li S,
Singh A, Norris KC, Klag MJ, Bakris GL; for the KEEP Investigators. Independent Components of
Chronic Kidney Disease as a Cardiovascular Risk State: Results From the Kidney Early Evaluation
Program (KEEP). Arch Intern Med. 2007 Jun 11;167(11):1122-9. PMID: 17563019
M182) McCullough PA. Coronary artery disease. Clin J Am Soc Nephrol. 2007 May;2(3):611-6. Epub
2007 Mar 21. PMID: 17699471
M183) McCullough PA, Lepor NE. The rosiglitazone meta-analysis. Rev Cardiovasc Med. 2007
Spring;8(2):123-6. PMID: 17603430
M184) McCullough PA, Henry TD, Kennard ED, Kelsey SF, Michaels AD; for the IEPR Investigators.
Residual high-grade angina after enhanced external counterpulsation therapy. Cardiovasc
Revasc Med. 2007 Jul-Sep;8(3):161-5. PMID: 17765644
M185) Miller WM, Nori Janosz KE, Zalesin KC, McCullough PA. Nutraceutical meal replacements:
more effective than all-food diets in the treatment of obesity. Therapy 2007, 4(5):623-639.
M186) Zalesin KC, Miller WM, Nori Janosz KE, Yanez J, Krause K, Chengelis DL, McCullough PA.
Controversies in vitamin D: deficiency and supplementation after Roux-en-Y gastric bypass
surgery. Therapy 2007, 4(5):561-574.
M187) Li S, Chen SC, Shlipak M, Bakris G, McCullough PA, Sowers J, Stevens L, Jurkovitz C,
McFarlane S, Norris K, Vassalotti J, Klag MJ, Brown WW, Narva A, Calhoun D, Johnson B, Obialo
C, Whaley-Connell A, Becker B, Collins AJ. Low birth weight is associated with chronic kidney
disease only in men. Kidney Int. 2008 Mar;73(5):637-42. PMID: 18094674
M188) Duru OK, Li S, Jurkovitz C, Bakris G, Brown W, Chen SC, Collins A, Klag M, McCullough PA,
McGill J, Narva A, Pergola P, Singh A, Norris K. Race and Sex Differences in Hypertension Control
in CKD: Results From the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2008
Feb;51(2):192-8. PMID: 18215697
M189) McCullough PA. Multimodality prevention of contrast-induced acute kidney injury. Am J
Kidney Dis. 2008 Feb;51(2):169-72. PMID: 18215694
M190) McCullough PA, Rocher LR. Statin therapy in renal disease: harmful or protective? Curr Diab
Rep. 2007 Dec;7(6):467-73. PMID: 18255012
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M191) Nori Janosz KE, Koenig Berris KA, Leff C, Miller WM, Yanez J, Myers S, Vial C, Vanderlinden M,
Franklin BA, McCullough PA. Clinical resolution of type 2 diabetes with reduction in body mass
index using meal replacement based weight loss. Vascular Disease Prevention vol.5, 17-
23(2008).
M192) Bellomo R, Auriemma S, Fabbri A, D'Onofrio A, Katz N, McCullough PA, Ricci Z, Shaw A,
Ronco C. The pathophysiology of cardiac surgery-associated acute kidney injury (CSA-AKI). Int J
Artif Organs. 2008 Feb;31(2):166-78. PMID: 18311733
M193) Bakris GL, Toto RD, McCullough PA, Rocha R, Purkayastha D, Davis P; GUARD (Gauging
Albuminuria Reduction With Lotrel in Diabetic Patients With Hypertension) Study Investigators.
Effects of different ACE inhibitor combinations on albuminuria: results of the GUARD study.
Kidney Int. 2008 Jun;73(11):1303-9. Epub 2008 Mar 19. PMID: 18354383
M194) McCullough PA, Li S, Jurkovitz CT, Stevens LA, Wang C, Collins AJ, Chen SC, Norris KC,
McFarlane SI, Johnson B, Shlipak MG, Obialo CI, Brown WW, Vassalotti JA, Whaley-Connell AT;
Kidney Early Evaluation Program Investigators. CKD and cardiovascular disease in screened high-
risk volunteer and general populations: the Kidney Early Evaluation Program (KEEP) and National
Health and Nutrition Examination Survey (NHANES) 1999-2004. Am J Kidney Dis. 2008 Apr;51(4
Suppl 2):S38-45. PMID: 18359407
M195) McFarlane SI, Chen SC, Whaley-Connell AT, Sowers JR, Vassalotti JA, Salifu MO, Li S, Wang C,
Bakris G, McCullough PA, Collins AJ, Norris KC; Kidney Early Evaluation Program Investigators.
Prevalence and associations of anemia of CKD: Kidney Early Evaluation Program (KEEP) and
National Health and Nutrition Examination Survey (NHANES) 1999-2004. Am J Kidney Dis. 2008
Apr;51(4 Suppl 2):S46-55. PMID: 18359408
M196) Vassalotti JA, Uribarri J, Chen SC, Li S, Wang C, Collins AJ, Calvo MS, Whaley-Connell AT,
McCullough PA, Norris KC; Kidney Early Evaluation Program Investigators. Trends in mineral
metabolism: Kidney Early Evaluation Program (KEEP) and the National Health and Nutrition
Examination Survey (NHANES) 1999-2004. Am J Kidney Dis. 2008 Apr;51(4 Suppl 2):S56-68.
PMID: 18359409
M197) Whaley-Connell AT, Sowers JR, Stevens LA, McFarlane SI, Shlipak MG, Norris KC, Chen SC,
Qiu Y, Wang C, Li S, Vassalotti JA, Collins AJ; Kidney Early Evaluation Program Investigators.
CKD in the United States: Kidney Early Evaluation Program (KEEP) and National Health and
Nutrition Examination Survey (NHANES) 1999-2004. Am J Kidney Dis. 2008 Apr;51(4 Suppl
2):S13-20. PMID: 18359403
M198) Whaley-Connell AT, Sowers JR, McFarlane SI, Norris KC, Chen SC, Li S, Qiu Y, Wang C, Stevens
LA, Vassalotti JA, Collins AJ; Kidney Early Evaluation Program Investigators. Diabetes mellitus in
CKD: Kidney Early Evaluation Program (KEEP) and National Health and Nutrition and Examination
Survey (NHANES) 1999-2004. Am J Kidney Dis. 2008 Apr;51(4 Suppl 2):S21-9. PMID: 18359404
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M199) McCullough PA. Acute kidney injury with iodinated contrast. Crit Care Med. 2008 Apr;36(4
Suppl):S204-11. PMID: 18382195
M200) deJong AT, Gallagher MJ, Sandberg KR, Lillystone MA, Spring T, Franklin BA, McCullough PA.
Peak oxygen consumption and the minute ventilation/carbon dioxide production relation slope
in morbidly obese men and women: influence of subject effort and body mass index. Prev
Cardiol. 2008 Spring;11(2):100-5. PMID: 18401238
M201) McCullough PA. Contrast-induced acute kidney injury. J Am Coll Cardiol. 2008 Apr
15;51(15):1419-28. PMID: 18402894
M202) Vanhecke TE, Gandhi M, McCullough PA, Lazar MH, Ravikrishnan KP, Kadaj P, Begle RL.
Outcomes of patients considered for, but not admitted to, the intensive care unit. Crit Care
Med. 2008 Mar;36(3):812-7. PMID: 18431268
M203) Zalesin KC, Krause KR, Chengelis DL, McCullough PA. Determinants of resolution of type 2
diabetes after bariatric surgery. Vascular Disease Prevention 2008;5(2):75-80.
M204) Miller W, Odom J, Veri S, Korponic S, Lillystone M, McCullough PA. Impact of short-term
educational and behavioral therapy on childhood obesity. Vascular Disease Prevention 2008;
5(2):129-134.
M205) Vanhecke TE, Franklin BA, Ajluni SC, Sangal RB, McCullough PA. Cardiorespiratory fitness
and sleep-related breathing disorders. Expert Rev Cardiovasc Ther. 2008 Jun;6(5):745-58.
PMID: 18510490
M206) Gebreegziabher Y, McCullough PA, Bubb C, Loney-Hutchinson L, Makaryus JN, Anand N,
Divakaran V, Akhrass P, Alam A, Gizycki H, McFarlane SI. Admission hyperglycemia and length of
hospital stay in patients with diabetes and heart failure: a prospective cohort study. Congest
Heart Fail. 2008 May-Jun;14(3):117-20. PMID: 18550921
M207) O'Donoghue M, Boden WE, Braunwald E, Cannon CP, Clayton TC, de Winter RJ, Fox KA,
Lagerqvist B, McCullough PA, Murphy SA, Spacek R, Swahn E, Wallentin L, Windhausen F,
Sabatine MS. Early invasive vs conservative treatment strategies in women and men with
unstable angina and non-ST-segment elevation myocardial infarction: a meta-analysis. JAMA.
2008 Jul 2;300(1):71-80. PMID: 18594042
M208) Franklin BA, McCullough PA. The "Null Effect" of Low-Density Lipoprotein Cholesterol
Lowering on a Modest Baseline Intima-Media Thickness: Lessons Learned From the ENHANCE
Trial. Prev Cardiol. 2008 Summer;11(3):177-8.
M209) Agrawal V, Kizilbash SH, McCullough PA. New therapeutic agents for diabetic kidney disease.
Therapy. 2008 Jun;5(4):553-75.
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M210) Vanhecke TE, Berman AD, McCullough PA. Body weight limitations of United States cardiac
catheterization laboratories including restricted access for the morbidly obese. Am J Cardiol.
2008 Aug 1;102(3):285-6.
M211) Saab G, Whaley-Connell AT, McCullough PA, Bakris GL. CKD awareness in the United States:
the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2008 Aug;52(2):382-3.
M212) McCullough PA, Li S, Jurkovitz CT, Stevens L, Collins AJ, Chen SC, Norris KC, McFarlane S,
Johnson B, Shlipak MG, Obialo CI, Brown WW, Vassaloti J, Whaley-Connell AT, Brenner RM,
Bakris GL; KEEP Investigators. Chronic kidney disease, prevalence of premature cardiovascular
disease, and relationship to short-term mortality. Am Heart J. 2008 Aug;156(2):277-83. Epub
2008 Jun 4. PMID: 18657657
M213) McCullough PA, Lepor NE. Lipids, biomarkers, and noninvasive imaging of atherosclerotic
disease activity in clinical trials. Rev Cardiovasc Med. 2008 Spring;9(2):142-9. PMID: 18660735
M214) McCullough PA, Agrawal V, Danielewicz E, Abela GS. Accelerated Atherosclerotic
Calcification and Mönckeberg’s Sclerosis: A Continuum of Advanced Vascular Pathology in
Chronic Kidney Disease. Clin J Am Soc Nephrol. 2008 Nov;3(6):1585-98. PMID: 18667741
M215) Boerrigter G, Costello-Boerrigter LC, Abraham WT, Sutton MG, Heublein DM, Kruger KM, Hill
MR, McCullough PA, Burnett JC Jr. Cardiac resynchronization therapy improves renal function in
human heart failure with reduced glomerular filtration rate. J Card Fail. 2008 Sep;14(7):539-46.
Epub 2008 May 27. PMID: 18722318
M216) Zalesin KC, Franklin BA, Miller WM, Peterson ED, McCullough PA. Impact of obesity on
cardiovascular disease. Endocrinol Metab Clin North Am. 2008 Sep;37(3):663-84. PMID:
18775358
M217) Vanhecke TE, Franklin BA, Zalesin KC, Sangal RB, deJong AT, Agrawal V, McCullough PA.
Cardiorespiratory fitness and obstructive sleep apnea syndrome in morbidly obese patients.
Chest. 2008 Sep;134(3):539-45. PMID: 18779193
M218) Madala MC, Franklin BA, Chen AY, Berman AD, Roe MT, Peterson ED, Ohman EM, Smith SC
Jr, Gibler WB, McCullough PA; CRUSADE Investigators. Obesity and Age of First Non-ST-Segment
Elevation Myocardial Infarction. J Am Coll Cardiol. 2008 Sep 16;52(12):979-985. PMID:
18786477
M219) Agrawal V, Khan I, Rai B, Krause KR, Chengelis DL, Zalesin KC, Rocher LL, McCullough PA. The
effect of weight loss after bariatric surgery on albuminuria. Clin Nephrol. 2008 Sep;70(3):194-
202. PMID: 18793560
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M220) Efstratiadis S, Kennard ED, Kelsey SF, Michaels AD; International EECP Patient Registry-2
Investigators.(McCullough PA, site Principal Investigator) Passive tobacco exposure may impair
symptomatic improvement in patients with chronic angina undergoing enhanced external
counterpulsation. BMC Cardiovasc Disord. 2008 Sep 17;8:23. PMID: 18798998
M221) McCullough PA. Radiocontrast-induced acute kidney injury. Nephron Physiol.
2008;109(4):p61-72. Epub 2008 Sep 18. PMID: 18802377
M222) McCullough PA. The impact of systemic calcified atherosclerosis in patients with chronic
kidney disease. Adv Chronic Kidney Dis. 2008 Oct;15(4):335-7. PMID: 18805378
M223) McCullough PA, Chinnaiyan KM, Agrawal V, Danielewicz E, Abela GS. Amplification of
atherosclerotic calcification and Mönckeberg's sclerosis: a spectrum of the same disease
process. Adv Chronic Kidney Dis. 2008 Oct;15(4):396-412. PMID: 18805386
M224) Agrawal V, Krause KR, Chengelis DL, Zalesin KC, Rocher LL, McCullough PA. Relation
between degree of weight loss after bariatric surgery and reduction in albuminuria and C-
reactive protein. Surg Obes Relat Dis. 2009 Jan-Feb;5(1):20-6. Epub 2008 Aug 5. PMID:
18951068
M225) Agrawal V, Ghosh AK, Barnes MA, McCullough PA. Awareness and Knowledge of Clinical
Practice Guidelines for CKD among Internal Medicine Residents: A National Online Survey. Am J
Kidney Dis. 2008 Dec;52(6):1061-9. Epub 2008 Oct 30. PMID: 18976845
M226) Jamerson K, Weber MA, Bakris GL, Dahlöf B, Pitt B, Shi V, Hester A, Gupte J, Gatlin M,
Velazquez EJ; ACCOMPLISH Trial Investigators. Benazepril plus amlodipine or
hydrochlorothiazide for hypertension in high-risk patients. (McCullough PA, Site Principal
Investigator) N Engl J Med. 2008 Dec 4;359(23):2417-28. PMID: 19052124
M227) Flemmer M, Rajab H, Mathena T, Paulson J, Perkins S, Whelan T, Chiu R, McCullough PA.
Blood B-type natriuretic peptide and dialysis: present assessment and future analyses. South
Med J. 2008 Nov;101(11):1094-100. PMID: 19088516
M228) Agrawal V, Ghosh AK, Barnes MA, McCullough PA. Perception of Indications for Nephrology
Referral among Internal Medicine Residents: A National Online Survey Clin J Am Soc Nephrol.
2009 Feb;4(2):323-8. PMID: 19218472
M229) Fried LF, Duckworth W, Zhang JH, O'Connor T, Brophy M, Emanuele N, Huang GD,
McCullough PA, Palevsky PM, Seliger S, Warren SR, Peduzzi P; for VA NEPHRON-D Investigators.
Design of Combination Angiotensin Receptor Blocker and Angiotensin-Converting Enzyme
Inhibitor for Treatment of Diabetic Nephropathy (VA NEPHRON-D). Clin J Am Soc Nephrol. 2009
Feb;4(2):361-8. Epub 2008 Dec 31. PMID: 19118120
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M230) Chinnaiyan KM, McCullough PA. Optimizing Outcomes in Coronary CT Imaging. Rev
Cardiovasc Med. 2008 Fall;9(4):215-24. PMID: 19122579
M231) Cardenas GA, Lavie CJ, Cardenas V, Milani RV, McCullough PA. The importance of
recognizing and treating low levels of high-density lipoprotein cholesterol: a new era in
atherosclerosis management. Rev Cardiovasc Med. 2008 Fall;9(4):239-58. PMID: 19122582
M232) Chinnaiyan KM, McCullough PA, Flohr TG, Wegner JH, Raff GL. Improved noninvasive
coronary angiography in morbidly obese patients with dual-source computed tomography. J
Cardiovasc Comput Tomogr. 2008 Dec 3. PMID: 19136325
M233) Soman P, Lahiri A, Mieres JH, Calnon DA, Wolinsky D, Beller GA, Sias T, Burnham K, Conway
L, McCullough PA, Daher E, Walsh MN, Wight J, Heller GV, Udelson JE. Etiology and
pathophysiology of new-onset heart failure: Evaluation by myocardial perfusion imaging. J Nucl
Cardiol. 2009 Jan-Feb;16(1):82-91. Epub 2009 Jan 20. PMID: 19152132
M234) Goldfarb S, McCullough PA, McDermott J, Gay SB. Contrast-induced acute kidney injury:
specialty-specific protocols for interventional radiology, diagnostic computed tomography
radiology, and interventional cardiology. Mayo Clin Proc. 2009 Feb;84(2):170-9. PMID:
19181651
M235) McCullough PA. Treatment disparities in patients with acute coronary syndromes and
kidney disease. Eur Heart J. 2009 Mar;30(5):526-7. PMID: 19201760
M236) Agrawal V, Ghosh AK, Barnes MA, McCullough PA. Perception of indications for nephrology
referral among internal medicine residents: a national online survey. Clin J Am Soc Nephrol.
2009 Feb;4(2):323-8. PMID: 19218472
M237) McCullough PA, Chinnaiyan KM. Hazards of contrast-induced acute kidney injury in elderly
women. Women’s Health (Lond Engl). 2009 Mar;5(2):123-5. PMID: 19245350
M238) Vanhecke TE, Franklin BA, Miller WM, deJong AT, Coleman CJ, McCullough PA.
Cardiorespiratory fitness and sedentary lifestyle in the morbidly obese. Clin Cardiol. 2009
Mar;32(3):121-4. PMID: 19301295
M239) Agrawal V, Marinescu V, Agarwal M, McCullough PA. Cardiovascular implications of
proteinuria: an indicator of chronic kidney disease. Nat Rev Cardiol. 2009 Apr;6(4):301-11.
PMID:19352334
M240) O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE,
Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F,
Piña IL; HF-ACTION Investigators.(McCullough PA Site Principal Investigator) Efficacy and safety
of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled
trial. JAMA. 2009 Apr 8;301(14):1439-50. PMID: 19351941
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M241) Vanhecke TE, Franklin BA, Maciejko J, Chinnaiyan K, McCullough PA. Lipoproteins,
inflammatory biomarkers, and cardiovascular imaging in the assessment of atherosclerotic
disease activity. Rev Cardiovasc Med. 2009 Winter;10(1):51-8. PMID:19367236
M242) Miller WM, Franklin BA, Nori Janosz KE, Vial C, Kaitner R, McCullough PA. Advantages of
group treatment and structured exercise in promoting short-term weight loss and cardiovascular
risk reduction in adults with central obesity. Metab Syndr Relat Disord 2009 May 18. PMID:
19450156
M243) Agrawal V, Swami A, Kosuri R, Alsabbagh M, Agarwal M, Samarapungavan D, Rocher LL,
McCullough PA. Contrast-induced acute kidney injury in renal transplant recipients after cardiac
catheterization. Clin Nephrol. 2009 Jun;71(6):687-96. PMID: 19473638
M244) Janosz KE, Zalesin KC, Miller WM, McCullough PA, Franklin BA. Impact of surgical and
nonsurgical weight loss on diabetes resolution and cardiovascular risk reduction. Curr Diab Rep.
2009 Jun;9(3):223-8. PMID: 19490824
M245) McCullough PA, Neyou A. Comprehensive Review of the Relative Clinical Utility of B-Type
Natriuretic Peptide and N-Terminal Pro-B-Type Natriuretic Peptide Assays in Cardiovascular
Disease. Open Heart Failure Journal, 2009, 2, 6-17.
M246) Odom J, Zalesin KC, Washington TL, Miller WW, Hakmeh B, Zaremba DL, Altattan M,
Balasubramaniam M, Gibbs DS, Krause KR, Chengelis DL, Franklin BA, McCullough PA.
Behavioral Predictors of Weight Regain after Bariatric Surgery. Obes Surg. 2010 Mar;20(3):349-
56 PMID: 19554382
M247) McCullough PA, Agarwal M, Agrawal V. Review article: Risks of coronary artery calcification
in chronic kidney disease: do the same rules apply? Nephrology (Carlton). 2009 Jun;14(4):428-
36. PMID: 19563385
M248) Agrawal V, Shah A, Rice C, Franklin BA, McCullough PA. Impact of treating the metabolic
syndrome on chronic kidney disease. Nat Rev Nephrol. 2009 Sep;5(9):520-8. Epub 2009 Jul 28.
Review. PMID: 19636332
M249) Moe SM, Drüeke TB, Block GA, Cannata-Andía JB, Elder G, Fukagawa M, Jorgetti V, Ketteler
M, Langman CB, Levin A, MacLeod AM, McCann L, McCullough PA, Ott SM, Wang AY, Weisinger
JR, Wheeler DC, Eckardt KU, Kasiske BL, Uhlig K, Moorthi R, Earley A, Persson R. Introduction
and definition of CKD-MBD and the development of the guideline statements. Kidney Int Suppl.
2009 Aug;(113):S1-130. PMID: 19644521
M250) McCullough PA. Darapladib and atherosclerotic plaque: should lipoprotein-associated
phospholipase A2 be a therapeutic target? Curr Atheroscler Rep. 2009 Sep;11(5):334-7. PMID:
19664375
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M251) Agrawal V, Vanhecke TE, Rai B, Franklin BA, Sangal RB, McCullough PA. Albuminuria and
Renal Function in Obese Adults Evaluated for Obstructive Sleep Apnea. Nephron Clin Pract.
2009 Aug 12;113(3):c140-c147. PMID: 19672111
M252) Agrawal V, Barnes MA, Ghosh AK, McCullough PA. Questionnaire instrument to assess
knowledge of chronic kidney disease clinical practice guidelines among internal medicine
residents. J Eval Clin Pract. 2009 Aug;15(4):733-8. PMID: 19674226
M253) Franklin BA, McCullough PA. Cardiorespiratory fitness: an independent and additive marker
of risk stratification and health outcomes. Mayo Clin Proc. 2009 Sep;84(9):776-9. PMID:
19720774
M254) Lele S, Shah S, McCullough PA, Rajapurkar M. Serum catalytic iron as a novel biomarker of
vascular injury in acute coronary syndromes. EuroIntervention. 2009 Aug;5(3):336-42. PMID:
19736158
M255) McCullough PA, Hanzel GS. B-type natriuretic peptide and echocardiography in the
surveillance of severe mitral regurgitation prior to valve surgery. J Am Coll Cardiol. 2009 Sep
15;54(12):1107-9. PMID: 19744621
M256) Pahle AS, Sørli D, Omland T, Knudsen CW, Westheim A, Wu AH, Steg PG, McCord J, Nowak
RM, Hollander JE, Storrow AB, Abraham WT, McCullough PA, Maisel A. Impact of systemic
hypertension on the diagnostic performance of B-type natriuretic peptide in patients with acute
dyspnea. Am J Cardiol. 2009 Oct 1;104(7):966-71. PMID: 19766765
M257) McCullough PA. Commentary: contrast-induced nephropathy and long-term adverse
events: cause and effect? Nephrol Dial Transplant. 2009 Dec;24(12):3578-9. Epub 2009 Sep 25.
PMID: 19783600
M258) Saab G, Whaley-Connell A, McFarlane SI, Li S, Chen SC, Sowers JR, McCullough PA, Bakris GL;
Kidney Early Evaluation Program Investigators. Obesity is associated with increased parathyroid
hormone levels independent of glomerular filtration rate in chronic kidney disease. Metabolism.
2009 Oct 1. PMID: 19800639
M259) McMurray MD, Trivax JE, McCullough PA. Serum cystatin C, renal filtration function, and left
ventricular remodeling. Circ Heart Fail. 2009 Mar;2(2):86-9. PMID: 19808322
M260) Nori Janosz KE, Zalesin KC, Miller WM, McCullough PA. Treating type 2 diabetes: incretin
mimetics and enhancers. Ther Adv Cardiovasc Dis. 2009 Oct;3(5):387-95. PMID: 19808944
M261) Thakkar BV, Hirsch AT, Satran D, Bart BA, Barsness G, McCullough PA, Kennard ED, Kelsey SF,
Henry TD. The efficacy and safety of enhanced external counterpulsation in patients with
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peripheral arterial disease. Vasc Med. 2010 Feb;15(1):15-20. Epub 2009 Oct 19. PMID:
19841026
M262) Keteyian SJ, Isaac D, Thadani U, Roy BA, Bensimhon DR, McKelvie R, Russell SD, Hellkamp AS,
Kraus WE; HF-ACTION Investigators (McCullough PA Site Investigator). Safety of symptom-
limited cardiopulmonary exercise testing in patients with chronic heart failure due to severe left
ventricular systolic dysfunction. Am Heart J. 2009 Oct;158(4 Suppl):S72-7. PMID: 19782792
M263) Flynn KE, Lin L, Ellis SJ, Russell SD, Spertus JA, Whellan DJ, Piña IL, Fine LJ, Schulman KA,
Weinfurt KP; HF-ACTION Investigators (McCullough PA Site Investigator). Outcomes, health
policy, and managed care: relationships between patient-reported outcome measures and
clinical measures in outpatients with heart failure. Am Heart J. 2009 Oct;158(4 Suppl):S64-71.
PMID: 19782791
M264) Forman DE, Clare R, Kitzman DW, Ellis SJ, Fleg JL, Chiara T, Fletcher G, Kraus WE; HF-ACTION
Investigators (McCullough PA). Relationship of age and exercise performance in patients with
heart failure: the HF-ACTION study. Am Heart J. 2009 Oct;158(4 Suppl):S6-S15. PMID: 19782790
M265) Atchley AE, Kitzman DW, Whellan DJ, Iskandrian AE, Ellis SJ, Pagnanelli RA, Kao A, Abdul-
Nour K, O'Connor CM, Ewald G, Kraus WE, Borges-Neto S; HF-ACTION Investigators (McCullough
PA). Myocardial perfusion, function, and dyssynchrony in patients with heart failure: baseline
results from the single-photon emission computed tomography imaging ancillary study of the
Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION)
Trial. Am Heart J. 2009 Oct;158(4 Suppl):S53-63. PMID: 19782789
M266) Gardin JM, Leifer ES, Fleg JL, Whellan D, Kokkinos P, Leblanc MH, Wolfel E, Kitzman DW; HF-
ACTION Investigators (McCullough PA). Relationship of Doppler-Echocardiographic left
ventricular diastolic function to exercise performance in systolic heart failure: the HF-ACTION
study. Am Heart J. 2009 Oct;158(4 Suppl):S45-52. PMID: 19782788
M267) Felker GM, Whellan D, Kraus WE, Clare R, Zannad F, Donahue M, Adams K, McKelvie R, Piña
IL, O'Connor CM; HF-ACTION Investigators (McCullough PA). N-terminal pro-brain natriuretic
peptide and exercise capacity in chronic heart failure: data from the Heart Failure and a
Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) study. Am Heart J.
2009 Oct;158(4 Suppl):S37-44. PMID: 19782787
M268) Horwich TB, Leifer ES, Brawner CA, Fitz-Gerald MB, Fonarow GC; HF-ACTION Investigators
(McCullough PA). The relationship between body mass index and cardiopulmonary exercise
testing in chronic systolic heart failure. Am Heart J. 2009 Oct;158(4 Suppl):S31-6. PMID:
19782786
M269) Russell SD, Saval MA, Robbins JL, Ellestad MH, Gottlieb SS, Handberg EM, Zhou Y, Chandler B;
HF-ACTION Investigators (McCullough PA). New York Heart Association functional class predicts
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exercise parameters in the current era. Am Heart J. 2009 Oct;158(4 Suppl):S24-30. PMID:
19782785
M270) Piña IL, Kokkinos P, Kao A, Bittner V, Saval M, Clare B, Goldberg L, Johnson M, Swank A,
Ventura H, Moe G, Fitz-Gerald M, Ellis SJ, Vest M, Cooper L, Whellan D; HF-ACTION Investigators
(McCullough PA). Baseline differences in the HF-ACTION trial by sex. Am Heart J. 2009
Oct;158(4 Suppl):S16-23. PMID: 19782784
M271) O'Connor CM, Whellan DJ; HF-ACTION Investigators (McCullough PA). Understanding heart
failure through the HF-ACTION baseline characteristics. Am Heart J. 2009 Oct;158(4 Suppl):S1-5.
PMID: 19782783
M272) McCullough PA, Tumlin JA. Prostaglandin-Based Renal Protection Against Contrast-Induced
Acute Kidney Injury. Circulation. 2009 Nov 3;120(18):1749-51. PMID: 19841295
M273) McCullough PA, Khan M, James J. Serum cystatin C in the estimation of glomerular filtration
on chronic Angiotensin-converting enzyme inhibitor therapy: an illustrative case report. J Clin
Hypertens (Greenwich). 2009 Nov;11(11):651-5. PMID: 19878376
M274) Agrawal V, Agarwal M, Ghosh AK, Barnes MA, McCullough PA. Identification and
Management of Chronic Kidney Disease Complications by Internal Medicine Residents: A
National Survey. Am J Ther. 2009 Nov 14. PMID: 19918169
M275) Zalesin KC, Franklin BA, Lillystone MA, Shamoun T, Krause KR, Chengelis DL, Mucci SJ,
Shaheen KW, McCullough PA. Differential Loss of Fat and Lean Mass in the Morbidly Obese
after Bariatric Surgery. Metab Syndr Relat Disord. 2010 Feb;8(1):15-20. PMID: 19929598
M276) Lubanski MS, McCullough PA. Kidney's role in hypertension. Minerva Cardioangiol. 2009
Dec;57(6):743-59. PMID: 19942846
M277) Agrawal V, Rai B, Fellows J, McCullough PA. In-hospital outcomes with thrombolytic therapy
in patients with renal dysfunction presenting with acute ischaemic stroke. Nephrol Dial
Transplant. 2010 Apr;25(4):1150-7. Epub 2009 Nov 27. PMID: 19945951
M278) McCullough PA, Chinnaiyan KM. Annual progression of coronary calcification in trials of
preventive therapies: a systematic review. Arch Intern Med. 2009 Dec 14;169(22):2064-70.
PMID: 20008688
M279) Ronco C, McCullough P, Anker SD, Anand I, Aspromonte N, Bagshaw SM, Bellomo R, Berl T,
Bobek I, Cruz DN, Daliento L, Davenport A, Haapio M, Hillege H, House AA, Katz N, Maisel A,
Mankad S, Zanco P, Mebazaa A, Palazzuoli A, Ronco F, Shaw A, Sheinfeld G, Soni S, Vescovo G,
Zamperetti N, Ponikowski P; for the Acute Dialysis Quality Initiative (ADQI) consensus group.
Cardio-renal syndromes: report from the consensus conference of the Acute Dialysis Quality
Initiative. Eur Heart J. 2010 Mar;31(6):703-11. Epub 2009 Dec 25. PMID: 20037146
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M280) Whaley-Connell A, Pavey BS, McCullough PA, Saab G, Li S, McFarlane SI, Chen SC, Vassalotti
JA, Collins AJ, Bakris G, Sowers JR; KEEP Investigators. Dysglycemia predicts cardiovascular and
kidney disease in the Kidney Early Evaluation Program. J Clin Hypertens (Greenwich). 2010
Jan;12(1):51-8. PMID: 20047632
M281) McCullough PA, Whaley-Connell A, Brown WW, Collins AJ, Chen SC, Li S, Norris KC, Jurkovitz
C, McFarlane S, Obialo C, Sowers J, Stevens L, Vassalotti JA, Bakris GL; on Behalf of the KEEP
Investigators. Cardiovascular risk modification in participants with coronary disease screened by
the Kidney Early Evaluation Program. Intern Med J. 2010 Dec;40(12):833-41. doi:
10.1111/j.1445-5994.2009.02158.x. PMID: 21199222
M282) Vassalotti JA, Li S, McCullough PA, Bakris GL. Kidney Early Evaluation Program: A
Community-Based Screening Approach to Address Disparities in Chronic Kidney Disease. Semin
Nephrol. 2010 Jan;30(1):66-73. PMID: 20116650
M283) Trivax JE, Franklin BA, Goldstein JA, Chinnaiyan KM, Gallagher MJ, Dejong AT, Colar JM,
Haines DE, McCullough PA. Acute Cardiac Effects of Marathon Running. J Appl Physiol. 2010
May;108(5):1148-53. Epub 2010 Feb 11. PMID: 20150567
M284) McCullough PA, Vassalotti JA, Collins AJ, Chen SC, Bakris GL. NKF's Kidney Early Evaluation
Program (KEEP) annual data report 2009: executive summary. Am J Kidney Dis. 2010 Mar;55(3
Suppl 2):S1-3. PMID: 20172443
M285) Stevens LA, Li S, Wang C, Huang C, Becker BN, Bomback AS, Brown WW, Burrows NR,
Jurkovitz CT, McFarlane SI, Norris KC, Shlipak M, Whaley-Connell AT, Chen SC, Bakris GL,
McCullough PA. Prevalence of CKD and comorbid illness in elderly patients in the United States:
results from the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2010 Mar;55(3 Suppl
2):S23-33.PMID: 20172445
M286) Bomback AS, Kshirsagar AV, Whaley-Connell AT, Chen SC, Li S, Klemmer PJ, McCullough PA,
Bakris GL. Racial differences in kidney function among individuals with obesity and metabolic
syndrome: results from the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2010
Mar;55(3 Suppl 2):S4-S14.PMID: 20172446
M287) Bagshaw SM, Cruz DN, Aspromonte N, Daliento L, Ronco F, Sheinfeld G, Anker SD, Anand I,
Bellomo R, Berl T, Bobek I, Davenport A, Haapio M, Hillege H, House A, Katz N, Maisel A, Mankad
S, McCullough P, Mebazaa A, Palazzuoli A, Ponikowski P, Shaw A, Soni S, Vescovo G, Zamperetti
N, Zanco P, Ronco C; for the Acute Dialysis Quality Initiative (ADQI) Consensus Group.
Epidemiology of cardio-renal syndromes: workgroup statements from the 7th ADQI Consensus
Conference. Nephrol Dial Transplant. 2010 May;25(5):1406-16. Epub 2010 Feb 25. PMID:
20185818
M288) McCullough PA. Transplantation: Coronary angiography prior to renal transplantation. Nat
Rev Nephrol. 2010 Mar;6(3):136-7. PMID: 20186230
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M289) McCullough PA, Verrill TA. Cardiorenal interaction: appropriate treatment of cardiovascular
risk factors to improve outcomes in chronic kidney disease. Postgrad Med. 2010 Mar;122(2):25-
34.PMID: 20203453
M290) Toth PP, McCullough PA, Wegner MS, Colley KJ. Lipoprotein-associated phospholipase A2:
role in atherosclerosis and utility as a cardiovascular biomarker. Expert Rev Cardiovasc Ther.
2010 Mar;8(3):425-38.PMID: 20222820
M291) Stolker JM, McCullough PA, Rao S, Inzucchi SE, Spertus JA, Maddox TM, Masoudi FA, Xiao L,
Kosiborod M. Pre-procedural glucose levels and the risk for contrast-induced acute kidney
injury in patients undergoing coronary angiography. J Am Coll Cardiol. 2010 Apr 6;55(14):1433-
40.PMID: 20359592
M292) House AA, Anand I, Bellomo R, Cruz D, Bobek I, Anker SD, Aspromonte N, Bagshaw S, Berl T,
Daliento L, Davenport A, Haapio M, Hillege H, McCullough P, Katz N, Maisel A, Mankad S, Zanco
P, Mebazaa A, Palazzuoli A, Ronco F, Shaw A, Sheinfeld G, Soni S, Vescovo G, Zamperetti N,
Ponikowski P, Ronco C; for the Acute Dialysis Quality Initiative (ADQI) consensus group.
Definition and classification of Cardio-Renal Syndromes: workgroup statements from the 7th
ADQI Consensus Conference. Nephrol Dial Transplant. 2010 May;25(5):1416-20. Epub 2010 Mar
12. PMID: 20228069
M293) Zalesin KC, Franklin, BA, Miller WL, Nori Janosz KE, Veri Silvia, Odom JO, McCullough PA.
Preventing Weight Regain After Bariatric Surgery: An Overview of Lifestyle and Psychosocial
Modulators. American Journal of Lifestyle Medicine, Vol. 4, No. 2, 113-120 (2010)
DOI:10.1177/1559827609351227
M294) McCullough PA, Haapio M, Mankad S, Zamperetti N, Massie B, Bellomo R, Berl T, Anker SD,
Anand I, Aspromonte N, Bagshaw SM, Bobek I, Cruz DN, Daliento L, Davenport A, Hillege H,
House AA, Katz N, Maisel A, Mebazaa A, Palazzuoli A, Ponikowski P, Ronco F, Shaw A, Sheinfeld
G, Soni S, Vescovo G, Zanco P, Ronco C, Berl T; for the Acute Dialysis Quality Initiative (ADQI)
Consensus Group. Prevention of cardio-renal syndromes: workgroup statements from the 7th
ADQI Consensus Conference. Nephrol Dial Transplant. 2010 Jun;25(6):1777-84. Epub 2010 Apr
6. PMID: 20375030
M295) Vanhecke TE, Kim R, Raheem SZ, McCullough PA. Myocardial ischemia in patients with
diastolic dysfunction and heart failure. Curr Cardiol Rep. 2010 May;12(3):216-22.PMID:
20424964
M296) Ronco C, McCullough PA, Anker SD, Anand I, Aspromonte N, Bagshaw SM, Bellomo R, Berl T,
Bobek I, Cruz DN, Daliento L, Davenport A, Haapio M, Hillege H, House A, Katz NM, Maisel A,
Mankad S, Zanco P, Mebazaa A, Palazzuoli A, Ronco F, Shaw A, Sheinfeld G, Soni S, Vescovo G,
Zamperetti N, Ponikowski P. Cardiorenal Syndromes: An Executive Summary from the
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Consensus Conference of the Acute Dialysis Quality Initiative (ADQI). Contrib Nephrol.
2010;165:54-67. Epub 2010 Apr 20.PMID: 20427956
M297) McCullough PA. Prevention of Cardiorenal Syndromes. Contrib Nephrol. 2010;165:101-111.
Epub 2010 Apr 20. PMID: 20427960
M298) Signori C, Zalesin KC, Franklin B, Miller WL, McCullough PA. Effect of Gastric Bypass on
Vitamin D and Secondary Hyperparathyroidism. Obes Surg. 2010 Jul;20(7):949-52. PMID:
20443152
M299) Davenport A, Anker SD, Mebazaa A, Palazzuoli A, Vescovo G, Bellomo R, Ponikowski P, Anand
I, Aspromonte N, Bagshaw S, Berl T, Bobek I, Cruz DN, Daliento L, Haapio M, Hillege H, House A,
Katz N, Maisel A, Mankad S, McCullough P, Ronco F, Shaw A, Sheinfeld G, Soni S, Zamperetti N,
Zanco P, Ronco C; Acute Dialysis Quality Initiative (ADQI) consensus group. ADQI 7: the clinical
management of the Cardio-Renal syndromes: work group statements from the 7th ADQI
consensus conference. Nephrol Dial Transplant. 2010 Jul;25(7):2077-89. Epub 2010 May 20.
PMID: 20494894
M300) Szczech LA, Granger CB, Dasta JF, Amin A, Peacock WF, McCullough PA, Devlin JW, Weir MR,
Katz JN, Anderson FA Jr, Wyman A, Varon J; for the Studying the Treatment of Acute
Hypertension Investigators. Acute Kidney Injury and Cardiovascular Outcomes in Acute Severe
Hypertension. Circulation. 2010 May 25;121(20):2183-91. Epub 2010 May 10. PMID: 20458014
M301) Sica D, Oren RM, Gottwald MD, Mills RM; Scios 351 Investigators.(McCullough PA,
Investigator) Natriuretic and neurohormonal responses to nesiritide, furosemide, and combined
nesiritide and furosemide in patients with stable systolic dysfunction. Clin Cardiol. 2010
Jun;33(6):330-6.PMID: 20556802
M302) Soriano-Co M, Vanhecke TE, Franklin BA, Sangal RB, Hakmeh B, McCullough PA. Increased
central adiposity in morbidly obese patients with obstructive sleep apnoea. Intern Med J. 2011
Jul;41(7):560-6. PMID: 20546056
M303) McCullough PA, Zerka M, Heimbach E, Musialcyzk M, Spring T, deJong A, Jafri SS, Coleman C,
Washington T, Raheem S, Vanhecke T, Zalesin KC. Audiocardiography in the cardiovascular
evaluation of the morbidly obese. Clin Physiol Funct Imaging. 2010 Sep;30(5):369-74. PMID:
20618361
M304) McCullough PA, Verrill T. Lessons learned from acute myocardial infarction in patients with
chronic kidney disease. J Intern Med. 2010 Jul;268(1):38-9. No abstract available. PMID:
20642644
M305) McCullough PA, Franklin BA, Leifer E, Fonarow GC. Impact of Reduced Kidney Function on
Cardiopulmonary Fitness in Patients with Systolic Heart Failure. Am J Nephrol. 2010 Jul
22;32(3):226-233. PMID: 20664198
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M306) Warnock DG, Muntner P, McCullough PA, Zhang X, McClure LA, Zakai N, Cushman M,
Newsome BB, Kewalramani R, Steffes MW, Howard G, McClellan WM; REGARDS Investigators.
Kidney Function, Albuminuria, and All-Cause Mortality in the REGARDS (Reasons for Geographic
and Racial Differences in Stroke) Study. Am J Kidney Dis. 2010 Nov;56(5):861-71. Epub 2010 Aug
8. PMID: 20692752
M307) McCullough PA. Editorial: Contrast-Induced Acute Kidney Injury: Shifting from Elective to
Urgent Coronary Intervention. J Interv Cardiol. 2010 Oct;23(5):467-9. doi: 10.1111/j.1540-
8183.2010.00589.x. Epub 2010 Aug 19. PMID: 20731756
M308) Bomback AS, Rekhtman Y, Whaley-Connell AT, Kshirsagar AV, Sowers JR, Chen SC, Li S,
Chinnaiyan KM, Bakris GL, McCullough PA. Gestational diabetes alone, in the absence of
subsequent diabetes, is associated with microalbuminuria: results from the Kidney Early
Evaluation Program (KEEP). Diabetes Care. 2010 Dec;33(12):2586-91. Epub 2010 Aug 31. PMID:
20807871
M309) Neyou A, O'Neil B, Berman AD, Boura JA, McCullough PA. Determinants of markedly
increased B-type natriuretic peptide in patients with ST-segment elevation myocardial
infarction. Am J Emerg Med. 2011 Feb;29(2):141-7. Epub 2010 Mar 25. PMID: 20825778
M310) McCullough PA. Integration of the clinical laboratory in cardiovascular medicine. Rev
Cardiovasc Med. 2010;11 Suppl 2:S1-2. PMID: 20700097
M311) Lepor NE, McCullough PA. Differential diagnosis and overlap of acute chest discomfort and
dyspnea in the emergency department. Rev Cardiovasc Med. 2010;11 Suppl 2:S13-23.PMID:
20700098
M312) de Lemos JA, Peacock WF, McCullough PA. Natriuretic peptides in the prognosis and
management of acute coronary syndromes. Rev Cardiovasc Med. 2010;11 Suppl 2:S24-34.PMID:
20700099
M313) McCullough PA, Peacock WF, O'Neil B, de Lemos JA. Capturing the pathophysiology of acute
coronary syndromes with circulating biomarkers. Rev Cardiovasc Med. 2010;11 Suppl 2:S3-
12.PMID: 20700100
M314) McCullough PA, Peacock WF, O'Neil B, de Lemos JA, Lepor NE, Berkowitz R. An evidence-
based algorithm for the use of B-type natriuretic testing in acute coronary syndromes. Rev
Cardiovasc Med. 2010;11 Suppl 2:S51-65.PMID: 20700103
M315) Zalesin KC, Miller WM, Franklin B, Mudugal D, Rao Buragadda A, Boura J, Nori-Janosz K,
Chengelis DL, Krause KR, McCullough PA. Vitamin a deficiency after gastric bypass surgery: an
underreported postoperative complication. J Obes. 2011;2011. pii: 760695. Epub 2010 Sep
14.PMID: 20871833
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M316) Maisel AS, Katz N, Hillege HL, Shaw A, Zanco P, Bellomo R, Anand I, Anker SD, Aspromonte N,
Bagshaw SM, Berl T, Bobek I, Cruz DN, Daliento L, Davenport A, Haapio M, House AA, Mankad S,
McCullough P, Mebazaa A, Palazzuoli A, Ponikowski P, Ronco F, Sheinfeld G, Soni S, Vescovo G,
Zamperetti N, Ronco C; for the Acute Dialysis Quality Initiative (ADQI) consensus group.
Biomarkers in kidney and heart disease. Nephrol Dial Transplant. 2011 Jan;26(1):62-74. Epub
2010 Oct 26 PMID: 20978142
M317) McCullough PA. Cardiorenal syndromes: pathophysiology to prevention. Int J Nephrol.
2010 Dec 1;2010:762590.PMID: 2115153
M318) McCullough PA, Whaley-Connell A, Brown WW, Collins AJ, Chen SC, Li S, Norris KC, Jurkovitz
C, McFarlane S, Obialo C, Sowers J, Stevens L, Vassalotti JA, Bakris GL. Cardiovascular risk
modification in participants with coronary disease screened by the Kidney Early Evaluation
Program. Intern Med J. 2010 Dec;40(12):833-41. doi: 10.1111/j.1445-5994.2009.02158.x.PMID:
21199222
M319) Lubanski MS, Vanhecke TE, Chinnaiyan KM, Franklin BA, McCullough PA. Subclinical
coronary atherosclerosis identified by coronary computed tomographic angiography in
asymptomatic morbidly obese patients. Heart Int. 2010 Dec 31;5(2):e15. PubMed PMID:
21977300
M320) Rose JJ, Vanhecke TE, McCullough PA. Subarachnoid hemorrhage with neurocardiogenic
stunning. Rev Cardiovasc Med. 2010 Fall;11(4):254-63. PMID: 21389917
M321) McCullough PA. Micronutrients and cardiorenal disease: insights into novel assessments
and treatment. Blood Purif. 2011;31(1-3):177-85. Epub 2011 Jan 10. PMID: 21228587
M322) Alexander P, David S, McCullough PA. Drug-eluting coronary stents in patients with kidney
disease. Am J Kidney Dis. 2011 Feb;57(2):188-9. No abstract available. PMID: 21251538
M323) McCullough PA, Chinnaiyan KM, Gallagher MJ, Colar JM, Geddes T, Gold JM, Trivax JE.
Changes in renal markers and acute kidney injury after marathon running. Nephrology (Carlton).
2011 Feb;16(2):194-9. doi: 10.1111/j.1440-1797.2010.01354.x. PMID: 21272132
M324) McCullough PA, Ahmad A. Cardiorenal syndromes. World J Cardiol. 2011 Jan 26;3(1):1-9.
PMID: 21286212
M325) Poirier P, Cornier MA, Mazzone T, Stiles S, Cummings S, Klein S, McCullough PA, Ren Fielding
C, Franklin BA; on behalf of the AHA Obesity Committee of the Council on Nutrition, Physical
Activity, and Metabolism. Bariatric Surgery and Cardiovascular Risk Factors: A Scientific
Statement From the AHA. Circulation. 2011 Apr 19;123(15):1683-701. Epub 2011 Mar 14.
PMID: 21403092
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M326) Goel SK, Bellovich K, McCullough PA. Treatment of severe metastatic calcification and
calciphylaxis in dialysis patients. Goel SK, Bellovich K, McCullough PA. Int J Nephrol. 2011 Feb
24;2011:701603. PMID: 21423552
M327) McCullough PA, El-Ghoroury M, Yamasaki H. Early detection of acute kidney injury with
neutrophil gelatinase-associated lipocalin. J Am Coll Cardiol. 2011 Apr 26;57(17):1762-4. PMID:
21511112
M328) Madder RD, Hickman L, Crimmins GM, Puri M, Marinescu V, McCullough PA, Safian RD.
Validity of Estimated Glomerular Filtration Rates for Assessment of Baseline and Serial Renal
Function in Patients with Atherosclerotic Renal Artery Stenosis: Implications for Clinical Trials of
Renal Revascularization. Circ Cardiovasc Interv. 2011 Jun 1;4(3):219-25. Epub 2011 Apr 26.
PMID: 21521835
M329) Whaley-Connell A, Sowers JR, McCullough PA. The role of oxidative stress in the metabolic
syndrome. Rev Cardiovasc Med. 2011;12(1):21-9. PMID: 21546885
M330) McCullough PA, Capasso P. Patient Discomfort Associated with the Use of Intra-arterial
Iodinated Contrast Media: A Meta-Analysis of Comparative Randomized Controlled Trials. BMC
Med Imaging. 2011 May 24;11:12. doi:10.1186/1471-2342-11-12. PMID: 21609484
M331) Friedewald VE, Emmett M, McCullough P, Yancy CW, Roberts WC. The Editor's Roundtable:
Anemia and Cardiovascular Disease. Am J Cardiol. 2011 Jun 1;107(11):1630-5. PMID: 21575751
M332) McCullough PA, Maynard RC. Treatment disparities in acute coronary syndromes, heart
failure, and kidney disease. Contrib Nephrol. 2011;171:68-73. Epub 2011 May 23. PMID:
21625092
M333) McCullough PA, Vassalotti JA, Collins AJ, Chen SC, Bakris GL, Whaley-Connell AT. National
Kidney Foundation's Kidney Early Evaluation Program (KEEP) Annual Data Report 2010:
Executive Summary. Am J Kidney Dis. 2011 Mar;57(3 Suppl 2):S1-3. PMID: 21338845
M334) McFarlane SI, McCullough PA, Sowers JR, Soe K, Chen SC, Li S, Vassalotti JA, Stevens LA,
Salifu MO, Kurella Tamura M, Bomback AS, Norris KC, Collins AJ, Bakris GL, Whaley-Connell AT;
KEEP Steering Committee. Comparison of the CKD Epidemiology Collaboration (CKD-EPI) and
Modification of Diet in Renal Disease (MDRD) Study Equations: Prevalence of and Risk Factors
for Diabetes Mellitus in CKD in the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis.
2011 Mar;57(3 Suppl 2):S24-31. PMID: 21338847
M335) McCullough PA, Brown WW, Gannon MR, Vassalotti JA, Collins AJ, Chen SC, Bakris GL,
Whaley-Connell AT. Sustainable Community-Based CKD Screening Methods Employed by the
National Kidney Foundation's Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2011
Mar;57(3 Suppl 2):S4-8. PMID: 21338848
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M336) Stevens LA, Li S, Kurella Tamura M, Chen SC, Vassalotti JA, Norris KC, Whaley-Connell AT,
Bakris GL, McCullough PA. Comparison of the CKD Epidemiology Collaboration (CKD-EPI) and
Modification of Diet in Renal Disease (MDRD) Study Equations: Risk Factors for and
Complications of CKD and Mortality in the Kidney Early Evaluation Program (KEEP). Am J Kidney
Dis. 2011 Mar;57(3 Suppl 2):S9-S16. PMID: 21338849
M337) Herzog CA, Asinger RW, Berger AK, Charytan DM, Díez J, Hart RG, Eckardt KU, Kasiske BL,
McCullough PA, Passman RS, DeLoach SS, Pun PH, Ritz E. Cardiovascular disease in chronic
kidney disease. A clinical update from Kidney Disease: Improving Global Outcomes (KDIGO).
Kidney Int. 2011 Sep;80(6):572-86. PMID: 21750584
M338) Gorges RD, Burke P, David W, Cole A, McCullough PA, David SW. Emerging practice patterns
and outcomes of percutaneous aortic balloon valvuloplasty in patients with severe aortic
stenosis. Rev Cardiovasc Med. 2011;12(2):e60-7. PMID: 21796084
M339) Hanna K, Seder CW, Chengelis D, McCullough PA, Krause K. Shorter circular staple is height
associated with lower anastomotic stricture rate in laparoscopic gastric bypass. Surg Obes Relat
Dis. 2012 Mar-Apr;8(2):181-4. PMID: 21798822
M340) Miller WM, Spring TJ, Zalesin KC, Kaeding KR, Nori Janosz KE, McCullough PA, Franklin BA.
Lower Than Predicted Resting Metabolic Rate Is Associated With Severely Impaired
Cardiorespiratory Fitness in Obese Individuals. Obesity (Silver Spring). 2012 Mar;20(3):505-11.
PMID: 21836645
M341) Zalesin KC, Franklin BA, Miller WM, Peterson ED, McCullough PA. Impact of obesity on
cardiovascular disease. Med Clin North Am. 2011 Sep;95(5):919-37. PMID: 21855700
M342) Khouri Y, Steigerwalt SP, Alsamara M, McCullough PA. What is the Ideal Blood Pressure Goal
for Patients with Stage III or Higher Chronic Kidney Disease? Curr Cardiol Rep. 2011
Dec;13(6):492-501. PMID: 21887524
M343) Brown JR, McCullough PA, Splaine ME, Davies L, Ross CS, Dauerman HL, Robb JF, Boss R,
Goldberg DJ, Fedele FA, Kellett MA, Phillips WJ, Ver Lee PN, Nelson EC, Mackenzie TA, O'Connor
GT, Sarnak MJ, Malenka DJ; for the Northern New England Cardiovascular Disease Study Group.
How do centres begin the process to prevent contrast-induced acute kidney injury: a report
from a new regional collaborative. BMJ Qual Saf. 2012 Jan;21(1):54-62. PMID: 21890755
M344) Horwich TB, Broderick S, Chen L, McCullough PA, Strzelczyk T, Kitzman DW, Fletcher G,
Safford RE, Ewald G, Fine LJ, Ellis SJ, Fonarow GC. Relation Among Body Mass Index, Exercise
Training, and Outcomes in Chronic Systolic Heart Failure. Am J Cardiol. 2011 Dec
15;108(12):1754-9. PMID: 21907317
M345) McCullough PA, Khambatta S, Jazrawi A. Minimizing the renal toxicity of iodinated contrast.
Circulation. 2011 Sep 13;124(11):1210-1. PMID: 21911794
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M346) Marinescu V, McCullough PA. Nutritional and micronutrient determinants of idiopathic
dilated cardiomyopathy: diagnostic and therapeutic implications. Expert Rev Cardiovasc Ther.
2011 Sep;9(9):1161-70. PubMed PMID: 21932959
M347) McCullough PA, Brown JR. Effects of Intra-Arterial and Intravenous Iso-Osmolar Contrast
Medium (Iodixanol) on the Risk of Contrast-Induced Acute Kidney Injury: A Meta-Analysis.
Cardiorenal Med. 2011;1(4):220-234. PMID: 22164156
M348) McCullough PA, Al-Ejel F, Maynard RC. Lipoprotein subfractions and particle size in end-
stage renal disease. Clin J Am Soc Nephrol. 2011 Dec;6(12):2738-9. PMID: 22157706
M349) Lepor NE, McCullough PA. Assessing appropriateness of coronary intervention. Rev
Cardiovasc Med. 2011;12(3):170-1. PMID: 22145194
M350) McCullough PA, Ahmed AB, Zughaib MT, Glanz ED, Di Loreto MJ. Treatment of
hypertriglyceridemia with fibric Acid derivatives: impact on lipid subfractions and translation
into a reduction in cardiovascular events. Rev Cardiovasc Med. 2011;12(4):173-85. PMID:
22249508.
M351) Palazzuoli A, Beltrami M, Nodari S, McCullough PA, Ronco C. Clinical impact of renal
dysfunction in heart failure. Rev Cardiovasc Med. 2011;12(4):186-99. PMID: 22249509.
M352) McCullough PA, Olobatoke A, Vanhecke TE. Galectin-3: a novel blood test for the evaluation
and management of patients with heart failure. Rev Cardiovasc Med. 2011;12(4):200-10. PMID:
22249510.
M353) Vanhecke TE, Franklin BA, Soman P, Lahiri A, Mieres JH, Sias T, Calnon DA, Wolinsky D,
Udelson JE, McCullough PA. Influence of myocardial ischemia on outcomes in patients with
systolic versus non-systolic heart failure. Am J Cardiovasc Dis. 2011;1(2):167-75. Epub 2011 Jul
27. PMID: 22254196.
M354) Whaley-Connell A, Bomback AS, McFarlane SI, Li S, Roberts T, Chen SC, Collins AJ, Norris K,
Bakris GL, Sowers JR, McCullough PA; on behalf of the Kidney Early Evaluation Program
Investigators. Diabetic Cardiovascular Disease Predicts Chronic Kidney Disease Awareness in the
Kidney Early Evaluation Program. Cardiorenal Med. 2011 Jan;1(1):45-52. Epub 2011 Jan 17.
PMID: 22258465.
M355) Saab G, Whaley-Connell A, Bombeck A, Kurella Tamura M, Li S, Chen SC, McFarlane SI,
Sowers JR, Norris K, Bakris GL, McCullough PA; for the Kidney Early Evaluation Program
Investigators. The Association between Parathyroid Hormone Levels and the Cardiorenal
Metabolic Syndrome in Non-Diabetic Chronic Kidney Disease. Cardiorenal Med. 2011;1(2):123-
130. Epub 2011 Apr 15. PMID: 22258399.
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M356) Trivax JE, McCullough PA. Phidippides Cardiomyopathy: A Review and Case Illustration. Clin
Cardiol. 2012 Feb;35(2):69-73. PMID: 22222888.
M357) Peralta CA, Norris KC, Li S, Chang TI, Tamura MK, Jolly SE, Bakris G, McCullough PA, Shlipak
M; for the KEEP Investigators. Blood Pressure Components and End-stage Renal Disease in
Persons With Chronic Kidney Disease: The Kidney Early Evaluation Program (KEEP). Arch Intern
Med. 2012 Jan 9;172(1):41-47. PMID: 22232147.
M358) McCullough PA, Assad H. Diagnosis of Cardiovascular Disease in Patients with
Chronic Kidney Disease. Blood Purif. 2012 Jan 20;33(1-3):112-118. [Epub ahead of
print] PubMed PMID: 22269967.
M359) Amin AP, Salisbury AC, McCullough PA, Gosch K, Spertus JA, Venkitachalam L, Stolker JM,
Parikh CR, Masoudi FA, Jones PG, Kosiborod M. Trends in the incidence of acute kidney injury in
patients hospitalized with acute myocardial infarction. Arch Intern Med. 2012 Feb
13;172(3):246-53. PubMed PMID: 22332157.
M360) Whaley-Connell AT, Vassalotti JA, Collins AJ, Chen SC, McCullough PA. National Kidney
Foundation's Kidney Early Evaluation Program (KEEP) Annual Data Report 2011: Executive
Summary. Am J Kidney Dis. 2012 Mar;59(3 Suppl 2):S1-4. PubMed PMID: 22339897; PubMed
Central PMCID: PMC3285421.
M361) Shah A, Fried LF, Chen SC, Qiu Y, Li S, Cavanaugh KL, Norris KC, Whaley-Connell AT,
McCullough PA, Mehrotra R; KEEP Investigators. Associations Between Access to Care and
Awareness of CKD. Am J Kidney Dis. 2012 Mar;59(3 Suppl 2):S16-23. PubMed PMID: 22339898.
M362) Jurkovitz CT, Elliott D, Li S, Saab G, Bomback AS, Norris KC, Chen SC, McCullough PA, Whaley-
Connell AT; KEEP Investigators. Physician Utilization, Risk-Factor Control, and CKD Progression
Among Participants in the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2012
Mar;59(3 Suppl 2):S24-33. PubMed PMID: 22339899.
M363) Saab G, Chen SC, Li S, Bomback AS, Whaley-Connell AT, Jurkovitz CT, Norris KC, McCullough
PA; KEEP Investigators. Association of Physician Care With Mortality in Kidney Early Evaluation
Program (KEEP) Participants. Am J Kidney Dis. 2012 Mar;59(3 Suppl 2):S34-9. PubMed PMID:
22339900.
M364) Agrawal V, Jaar BG, Frisby XY, Chen SC, Qiu Y, Li S, Whaley-Connell AT, McCullough PA,
Bomback AS; KEEP Investigators. Access to Health Care Among Adults Evaluated for CKD:
Findings From the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2012 Mar;59(3
Suppl 2):S5-S15. PubMed PMID: 22339901.
M365) Ismail Y, Kasmikha Z, Green HL, McCullough PA. Cardio-renal syndrome type 1:
epidemiology, pathophysiology, and treatment. Semin Nephrol. 2012 Jan;32(1):18-25. PubMed
PMID: 22365158.
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M366) Khambatta S, Farkouh ME, Wright RS, Reeder GS, McCullough PA, Smars PA, Hickson LJ, Best
PJ. Chronic kidney disease as a risk factor for acute coronary syndromes in patients presenting to
the emergency room with chest pain. Transl Res. 2012 May;159(5):391-6. Epub 2012 Jan 9.
PubMed PMID: 22500512.
M367) Whaley-Connell A, Shlipak MG, Inker LA, Kurella Tamura M, Bomback AS, Saab G, Szpunar
SM, McFarlane SI, Li S, Chen SC, Norris K, Bakris GL, McCullough PA; Kidney Early Evaluation
Program Investigators. Awareness of Kidney Disease and Relationship to End-stage Renal
Disease and Mortality. Am J Med. 2012 Jul;125(7):661-9. PubMed PMID: 22626510.
M368) McCullough PA, Williams FJ, Stivers DN, Cannon L, Dixon S, Alexander P, Runyan D, David S.
Neutrophil Gelatinase-Associated Lipocalin: A Novel Marker of Contrast Nephropathy Risk. Am J
Nephrol. 2012 May 23;35(6):509-514. PubMed PMID: 22627273.
M369) O'Keefe JH, Patil HR, Lavie CJ, Magalski A, Vogel RA, McCullough PA. Potential adverse
cardiovascular effects from excessive endurance exercise. Mayo Clin Proc. 2012 Jun;87(6):587-
95. PubMed PMID: 22677079.
M370) McCullough PA, Ali S. Cardiac and renal function in patients with type 2 diabetes who have
chronic kidney disease: potential effects of bardoxolone methyl. Drug Des Devel Ther.
2012;6:141-9. Epub 2012 Jun 14. PubMed PMID: 22787387; PubMed Central PMCID:
PMC3392144.
M371) O'Donoghue ML, Vaidya A, Afsal R, Alfredsson J, Boden WE, Braunwald E, Cannon CP,
Clayton TC, de Winter RJ, Fox KA, Lagerqvist B, McCullough PA, Murphy SA, Spacek R, Swahn E,
Windhausen F, Sabatine MS. An Invasive or Conservative Strategy in Patients With Diabetes
Mellitus and Non-ST-Segment Elevation Acute Coronary Syndromes: A Collaborative Meta-
Analysis of Randomized Trials. J Am Coll Cardiol. 2012 Jul 10;60(2):106-11. PubMed PMID:
22766336.
M372) Ronco C, Cicoira M, McCullough PA. Cardiorenal Syndrome Type 1: Pathophysiological
Crosstalk Leading to Combined Heart and Kidney Dysfunction in the Setting of Acutely
Decompensated Heart Failure. J Am Coll Cardiol. 2012 Sep 18;60(12):1031-42. PubMed PMID:
22840531.
M373) Ronco C, Stacul F, McCullough PA. Subclinical acute kidney injury (AKI) due to iodine-based
contrast media. Eur Radiol. 2013 Feb;23(2):319-23. PubMed PMID: 22895617.
M374) McCullough PA, Larsen T, Brown JR. Theophylline or aminophylline for the prevention of
contrast-induced acute kidney injury. Am J Kidney Dis. 2012 Sep;60(3):338-9. PubMed PMID:
22901629.
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M375) Patil HR, O'Keefe JH, Lavie CJ, Magalski A, Vogel RA, McCullough PA. Cardiovascular damage
resulting from chronic excessive endurance exercise. Mo Med. 2012 Jul-Aug;109(4):312-21.
PubMed PMID: 22953596.
M376) Bose S, Bomback AS, Mehta NN, Chen SC, Li S, Whaley-Connell A, Benjamin J, McCullough
PA. Dysglycemia but not lipids is associated with abnormal urinary albumin excretion in diabetic
kidney disease: a report from the Kidney Early Evaluation Program (KEEP). BMC Nephrol. 2012
Sep 7;13:104. doi:10.1186/1471-2369-13-104. PubMed PMID: 22958709.
M377) Wilson GD, Geddes TJ, Pruetz BL, Thibodeau BJ, Murawka A, Colar JM, McCullough PA,
Trivax JE. SELDI-TOF-MS Serum Profiling Reveals Predictors of Cardiac MRI Changes in Marathon
Runners. Int J Proteomics. 2012;2012:679301. Epub 2012 Sep 3. PubMed PMID: 22988506;
PubMed Central PMCID: PMC3439948.
M378) McCullough PA, Cowan S. Mineralocorticoid receptor antagonists and mortality in heart
failure with concurrent atrial fibrillation. Circ Heart Fail. 2012 Sep 1;5(5):550-1. PubMed PMID:
22991404.
M379) Saab G, Bomback AS, McFarlane SI, Li S, Chen SC, McCullough PA, Whaley-Connell A; for the
Kidney Early Evaluation Program Investigators. The Association of Parathyroid Hormone with
ESRD and Pre-ESRD Mortality in the Kidney Early Evaluation Program. J Clin Endocrinol Metab.
2012 Dec;97(12):4414-21. PubMed PMID: 23066118.
M380) Whaley-Connell A, Kurella Tamura M, McCullough PA. A Decade After the KDOQI CKD
Guidelines: Impact on the National Kidney Foundation's Kidney Early Evaluation Program (KEEP).
Am J Kidney Dis. 2012 Nov;60(5):692-3. doi: 10.1053/j.ajkd.2012.08.008. PubMed PMID:
23067631.
M381) McCullough PA, Di Loreto MJ. Fibrates and cardiorenal outcomes. J Am Coll Cardiol. 2012
Nov 13;60(20):2072-3. doi: 10.1016/j.jacc.2012.06.058. Epub 2012 Oct 17. PubMed PMID:
23083778.
M382) Babayev R, Whaley-Connell A, Kshirsagar A, Klemmer P, Navaneethan S, Chen SC, Li S,
McCullough PA, Bakris G, Bomback A; KEEP Investigators. Association of Race and Body Mass
Index With ESRD and Mortality in CKD Stages 3-4: Results From the Kidney Early Evaluation
Program (KEEP). Am J Kidney Dis. 2013 Mar;61(3):404-12. PubMed PMID: 23260275.
M383) Pinto de Carvalho L, McCullough PA, Gao F, Sim LL, Tan HC, Foo D, Ooi YW, Richards AM,
Chan MY, Yeo TC. Renal function and anaemia in acute myocardial infarction. Int J Cardiol. 2013
Sep 30;168(2):1397-401. PubMed PMID: 23305857.
M384) Kashani K, Al-Khafaji A, Ardiles T, Artigas A, Bagshaw SM, Bell M, Bihorac A, Birkhahn R, Cely
CM, Chawla LS, Davison DL, Feldkamp T, Forni LG, Gong MN, Gunnerson KJ, Haase M, Hackett J,
Honore PM, Hoste EA, Joannes-Boyau O, Joannidis M, Kim P, Koyner JL, Laskowitz DT, Lissauer
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ME, Marx G, McCullough PA, Mullaney S, Ostermann M, Rimmele T, Shapiro NI, Shaw AD, Shi J,
Sprague AM, Vincent JL, Vinsonneau C, Wagner L, Walker MG, Wilkerson RG, Zacharowski K,
Kellum JA. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury.
Crit Care. 2013 Feb 6;17(1):R25. [Epub ahead of print] PubMed PMID: 23388612.
M385) Smith SW, Diercks DB, Nagurney JT, Hollander JE, Miller CD, Schrock JW, Singer AJ, Apple FS,
McCullough PA, Ruff CT, Sesma A Jr, Peacock WF. Central versus local adjudication of myocardial
infarction in a cardiac biomarker trial. Am Heart J. 2013 Mar;165(3):273-279.e1. doi:
10.1016/j.ahj.2012.12.012. Epub 2013 Jan 26. PubMed PMID: 23453092.
M386) Whaley-Connell AT, Kurella Tamura M, Jurkovitz CT, Kosiborod M, McCullough PA.
Advances in CKD Detection and Determination of Prognosis: Executive Summary of the National
Kidney Foundation-Kidney Early Evaluation Program (KEEP) 2012 Annual Data Report. Am J
Kidney Dis. 2013 Apr;61(4 Suppl 2):S1-3. doi: 10.1053/j.ajkd.2013.01.006. PubMed PMID:
23507265; PubMed Central PMCID: PMC3608929.
M387) Amin AP, Whaley-Connell AT, Li S, Chen SC, McCullough PA, Kosiborod MN; KEEP
Investigators. The Synergistic Relationship Between Estimated GFR and Microalbuminuria in
Predicting Long-term Progression to ESRD or Death in Patients With Diabetes: Results From the
Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2013 Apr;61(4 Suppl 2):S12-23. doi:
10.1053/j.ajkd.2013.01.005. PubMed PMID: 23507266.
M388) Jurkovitz CT, Li S, Norris KC, Saab G, Bomback AS, Whaley-Connell AT, McCullough PA; KEEP
Investigators. Association Between Lack of Health Insurance and Risk of Death and ESRD: Results
From the Kidney Early Evaluation Program (KEEP). Am J Kidney Dis. 2013 Apr;61(4 Suppl 2):S24-
32. doi: 10.1053/j.ajkd.2012.12.015. PubMed PMID: 23507267.
M389) Chang TI, Li S, Chen SC, Peralta CA, Shlipak MG, Fried LF, Whaley-Connell AT, McCullough PA,
Kurella Tamura M; KEEP Investigators. Risk Factors for ESRD in Individuals With Preserved
Estimated GFR With and Without Albuminuria: Results From the Kidney Early Evaluation
Program (KEEP). Am J Kidney Dis. 2013 Apr;61(4 Suppl 2):S4-S11. doi:
10.1053/j.ajkd.2012.12.016. PubMed PMID: 23507268.
M390) Narala KR, Hassan S, Lalonde TA, McCullough PA. Management of coronary atherosclerosis
and acute coronary syndromes in patients with chronic kidney disease. Curr Probl Cardiol. 2013
May;38(5):165-206. doi: 10.1016/j.cpcardiol.2012.12.004. PubMed PMID: 23590761.
M391) Mehrotra R, Peralta CA, Chen SC, Li S, Sachs M, Shah A, Norris K, Saab G, Whaley-Connell A,
Kestenbaum B, McCullough PA. No independent association of serum phosphorus with risk for
death or progression to end-stage renal disease in a large screen for chronic kidney disease.
Kidney Int. 2013 Nov;84(5):989-97. PubMed PMID: 23615501.
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M392) Runyan D, Feldman D, McCullough PA, David S, Saba S, Gorges R. Long-term Follow-up of
Lesion-specific Outcomes Comparing Drug-eluting Stents and Bare Metal Stents in Diseased
Saphenous Vein Grafts. Rev Cardiovasc Med. 2013;14(1):1-6. PubMed PMID: 23651982.
M393) Lepor NE, Fouchia DD, McCullough PA. New vistas for the treatment of obesity: turning the
tide against the leading cause of morbidity and cardiovascular mortality in the developed world.
Rev Cardiovasc Med. 2013;14(1):20-40. PubMed PMID: 23651984.
M394) Weisbord SD, Gallagher M, Kaufman J, Cass A, Parikh CR, Chertow GM, Shunk KA,
McCullough PA, Fine MJ, Mor MK, Lew RA, Huang GD, Conner TA, Brophy MT, Lee J, Soliva S,
Palevsky PM. Prevention of Contrast-Induced AKI: A Review of Published Trials and the Design of
the Prevention of Serious Adverse Events following Angiography (PRESERVE) Trial. Clin J Am Soc
Nephrol. 2013 Sep;8(9):1618-31. PubMed PMID: 23660180
M395) McCullough PA, Bouchard J, Waikar SS, Siew ED, Endre ZH, Goldstein SL, Koyner JL, Macedo
E, Doi K, Di Somma S, Lewington A, Thadhani R, Chakravarthi R, Ice C, Okusa MD, Duranteau J,
Doran P, Yang L, Jaber BL, Meehan S, Kellum JA, Haase M, Murray PT, Cruz D, Maisel A, Bagshaw
SM, Chawla LS, Mehta RL, Shaw AD, Ronco C. Implementation of Novel Biomarkers in the
Diagnosis, Prognosis, and Management of Acute Kidney Injury: Executive Summary from the
Tenth Consensus Conference of the Acute Dialysis Quality Initiative (ADQI). Contrib Nephrol.
2013;182:5-12. doi: 10.1159/000349962. Epub 2013 May 13. PubMed PMID: 23689652.
M396) McCullough PA, Shaw AD, Haase M, Bouchard J, Waikar SS, Siew ED, Murray PT, Mehta RL,
Ronco C. Diagnosis of acute kidney injury using functional and injury biomarkers: workgroup
statements from the tenth acute dialysis quality initiative consensus conference. Contrib
Nephrol. 2013;182:13-29. doi: 10.1159/000349963. Epub 2013 May 13. PubMed PMID:
23689653.
M397) McCullough PA, Kellum JA, Haase M, Müller C, Damman K, Murray PT, Cruz D, House AA,
Schmidt-Ott KM, Vescovo G, Bagshaw SM, Hoste EA, Briguori C, Braam B, Chawla LS, Costanzo
MR, Tumlin JA, Herzog CA, Mehta RL, Rabb H, Shaw AD, Singbartl K, Ronco C. Pathophysiology of
the Cardiorenal Syndromes: Executive Summary from the Eleventh Consensus Conference of the
Acute Dialysis Quality Initiative (ADQI). Contrib Nephrol. 2013;182:82-98. doi:
10.1159/000349966. Epub 2013 May 13. PubMed PMID: 23689657.
M398) Haase M, Müller C, Damman K, Murray PT, Kellum JA, Ronco C, McCullough PA.
Pathogenesis of Cardiorenal Syndrome Type 1 in Acute Decompensated Heart Failure:
Workgroup Statements from the Eleventh Consensus Conference of the Acute Dialysis Quality
Initiative (ADQI). Contrib Nephrol. 2013;182:99-116. doi: 10.1159/000349969. Epub 2013 May
13. PubMed PMID: 23689658.
M399) Cruz DN, Schmidt-Ott KM, Vescovo G, House AA, Kellum JA, Ronco C, McCullough PA.
Pathophysiology of Cardiorenal Syndrome Type 2 in Stable Chronic Heart Failure: Workgroup
Statements from the Eleventh Consensus Conference of the Acute Dialysis Quality Initiative
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(ADQI). Contrib Nephrol. 2013;182:117-36. doi: 10.1159/000349968. Epub 2013 May 13.
PubMed PMID: 23689659.
M400) Bagshaw SM, Hoste EA, Braam B, Briguori C, Kellum JA, McCullough PA, Ronco C.
Cardiorenal syndrome type 3: pathophysiologic and epidemiologic considerations. Contrib
Nephrol. 2013;182:137-57. doi: 10.1159/000349971. Epub 2013 May 13. PubMed PMID:
23689660.
M401) Tumlin JA, Costanzo MR, Chawla LS, Herzog CA, Kellum JA, McCullough PA, Ronco C.
Cardiorenal Syndrome Type 4: Insights on Clinical Presentation and Pathophysiology from the
Eleventh Consensus Conference of the Acute Dialysis Quality Initiative (ADQI). Contrib Nephrol.
2013;182:158-73. doi: 10.1159/000349972. Epub 2013 May 13. PubMed PMID: 23689661.
M402) Mehta RL, Rabb H, Shaw AD, Singbartl K, Ronco C, McCullough PA, Kellum JA. Cardiorenal
Syndrome Type 5: Clinical Presentation, Pathophysiology and Management Strategies from the
Eleventh Consensus Conference of the Acute Dialysis Quality Initiative (ADQI). Contrib Nephrol.
2013;182:174-94. doi: 10.1159/000349970. Epub 2013 May 13. PubMed PMID: 23689662.
M403) McCullough PA, Barnhart HX, Inrig JK, Reddan D, Sapp S, Patel UD, Singh AK, Szczech LA,
Califf RM. Cardiovascular Toxicity of Epoetin-Alfa in Patients with Chronic Kidney Disease. Am J
Nephrol. 2013 May 25;37(6):549-558. PubMed PMID: 23735819.
M404) Memon I, Norris KC, Bomback AS, Peralta C, Li S, Chen SC, McCullough PA, Whaley-Connell
A, Jurkovitz C, Tamura MK, Saab G; for the Kidney Early Evaluation Program Investigators. The
Association between Parathyroid Hormone Levels and Hemoglobin in Diabetic and Nondiabetic
Participants in the National Kidney Foundation's Kidney Early Evaluation Program. Cardiorenal
Med. 2013 Jul;3(2):120-127. Epub 2013 Jun 1. PubMed PMID: 23922552; PubMed Central
PMCID: PMC3721130.
M405) McCullough PA, Barnard D, Clare R, Ellis SJ, Fleg JL, Fonarow GC, Franklin BA, Kilpatrick RD,
Kitzman DW, O'Connor CM, Piña IL, Thadani U, Thohan V, Whellan DJ; for the HF-ACTION
Investigators. Anemia and Associated Clinical Outcomes in Patients With Heart Failure Due to
Reduced Left Ventricular Systolic Function. Clin Cardiol. 2013 Oct;36(10):611-20. PubMed
PMID: 23929781.
M406) Akrawinthawong K, Shaw MK, Kachner J, Apostolov EO, Basnakian AG, Shah S, Tilak J,
McCullough PA. Urine catalytic iron and neutrophil gelatinase-associated lipocalin as companion
early markers of acute kidney injury after cardiac surgery: a prospective pilot study. Cardiorenal
Med. 2013 Apr;3(1):7-16. doi: 10.1159/000346815. Epub 2013 Feb 6. PubMed PMID: 23946721;
PubMed Central PMCID: PMC3743453.
M407) White WB, Cannon CP, Heller SR, Nissen SE, Bergenstal RM, Bakris GL, Perez AT, Fleck PR,
Mehta CR, Kupfer S, Wilson C, Cushman WC, Zannad F; EXAMINE Investigators. (McCullough PA,
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Data Safety Monitoring Board) Alogliptin after acute coronary syndrome in patients with type 2
diabetes. N Engl J Med. 2013 Oct 3;369(14):1327-35.
M408) McCullough PA, Akrawinthawong K. Ascorbic Acid for the Prevention of Contrast-Induced
Acute Kidney Injury. J Am Coll Cardiol. 2013 Dec 10;62(23):2176-7. PubMed PMID: 23994411.
M409) Ronco C, McCullough PA, Chawla LS. Kidney attack versus heart attack: evolution of
classification and diagnostic criteria. Lancet. 2013 Sep 14;382(9896):939-40. doi:
10.1016/S0140-6736(13)61932-7. PubMed PMID: 24034297.
M410) Kurella Tamura M, Li S, Chen SC, Cavanaugh KL, Whaley-Connell AT, McCullough PA,
Mehrotra RL. Educational programs improve the preparation for dialysis and survival of patients
with chronic kidney disease. Kidney Int. 2013 Sep 25. doi:10.1038/ki.2013.369. [Epub ahead of
print] PubMed PMID: 24067435.
M411) Nasser M, Larsen TR, Waanbah B, Sidiqi I, McCullough PA. Hyperacute drug-induced
hepatitis with intravenous amiodarone: case report and review of the literature. Drug Health
Patient Saf. 2013 Sep 26;5:191-198. PubMed PMID: 24109195.
M412) Larsen TR, Kinni V, Zaks J, David S, McCullough PA. A Lethal Case of Influenza and Type 5
Cardiorenal Syndrome. Blood Purif. 2013 Nov 1;36(2):112-115. PubMed PMID: 24192807.
M413) Fried LF, Emanuele N, Zhang JH, Brophy M, Conner TA, Duckworth W, Leehey DJ,
McCullough PA, O'Connor T, Palevsky PM, Reilly RF, Seliger SL, Warren SR, Watnick S, Peduzzi P,
Guarino P; VA NEPHRON-D Investigators. Combined Angiotensin inhibition for the treatment of
diabetic nephropathy. N Engl J Med. 2013 Nov 14;369(20):1892-903.
M414) Parsa A, Kao WH, Xie D, Astor BC, Li M, Hsu CY, Feldman HI, Parekh RS, Kusek JW, Greene TH,
Fink JC, Anderson AH, Choi MJ, Wright JT Jr, Lash JP, Freedman BI, Ojo A, Winkler CA, Raj DS,
Kopp JB, He J, Jensvold NG, Tao K, Lipkowitz MS, Appel LJ; AASK Study Investigators; CRIC Study
Investigators (McCullough PA, External Advisory Panel). APOL1 risk variants, race, and
progression of chronic kidney disease. N Engl J Med. 2013 Dec 5;369(23):2183-96.
M415) Costanzo MR, Chawla LS, Tumlin JA, Herzog CA, McCullough PA, Kellum JA, Ronco C. The role
of early and sufficient isolated venovenous ultrafiltration in heart failure patients with
pulmonary and systemic congestion. Rev Cardiovasc Med. 2013;14(2-4):e123-33. PubMed
PMID: 24448253.
M416) Maioli M, Toso A, Leoncini M, Musilli N, Bellandi F, Rosner MH, McCullough PA, Ronco C.
Pre-procedural Bioimpedance Vectorial Analysis of fluid status and prediction of Contrast-
Induced Acute Kidney Injury. J Am Coll Cardiol. 2014 Jan 30. pii: S0735-1097(14)00339-8. doi:
10.1016/j.jacc.2014.01.025. [Epub ahead of print] PubMed PMID: 24530668.
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M417) Chawla LS, Herzog CA, Costanzo MR, Tumlin J, Kellum JA, McCullough PA, Ronco C; Acute
Dialysis Quality Initiative (ADQI) XI Workgroup. Viewpoint: Proposal for a Functional
Classification System of Heart Failure in Patients with End-Stage Renal Disease: Proceedings of
the Acute Dialysis Quality Initiative (ADQI) XI Workgroup. J Am Coll Cardiol. 2014 Jan 30. pii:
S0735-1097(14)00331-3. doi: 10.1016/j.jacc.2014.01.020. [Epub ahead of print] Review.
PubMed PMID: 24530671.
M418) McCullough PA. Calling for Targeted Trials in Cardiorenal Syndromes. Am J Kidney Dis. 2014
Apr 5. pii: S0272-6386(14)00616-7. doi:10.1053/j.ajkd.2014.03.006. [Epub ahead of print]
PubMed PMID: 24713221.
M419) Toth PP, Shah PK, Wilkinson MJ, Davidson MH, McCullough PA. Use of microsomal
triglyceride transfer protein inhibitors in patients with homozygous familial
hypercholesterolemia: translating clinical trial experience into clinical practice. Rev Cardiovasc
Med. 2014;15(1):1-10. PubMed PMID: 24762461.
M420) McCullough PA, Beaver TM, Bennett-Guerrero E, Emmett M, Fonarow GC, Goyal A, Herzog
CA, Kosiborod M, Palmer BF. Acute and chronic cardiovascular effects of hyperkalemia: new
insights into prevention and clinical management. Rev Cardiovasc Med. 2014;15(1):11-23.
PubMed PMID: 24762462.
M421) McCullough PA. Practical experience using galectin-3 in heart failure. Clin Chem Lab Med.
2014 May 8. pii:/j/cclm.ahead-of-print/cclm-2014-0278/cclm-2014-0278.xml. doi:
10.1515/cclm-2014-0278. [Epub ahead of print] PubMed PMID: 24810562
M422) Chin MP, Reisman SA, Bakris GL, O'Grady M, Linde PG, McCullough PA, Packham D, Vaziri
ND, Ward KW, Warnock DG, Meyer CJ. Mechanisms Contributing to Adverse Cardiovascular
Events in Patients with Type 2 Diabetes Mellitus and Stage 4 Chronic Kidney Disease Treated
with Bardoxolone Methyl. Am J Nephrol. 2014 Jun 3;39(6):499-508. [Epub ahead of print]
PubMed PMID: 24903467.
M423) McCullough PA, Whaley-Connell AT, Vassalotti JA. The future of CKD detection: the role for
the Kidney Early Evaluation Program. Nephrol News Issues. 2014 Apr;28(4):41-2. PubMed PMID:
24960988.
M424) Palazzuoli A, Pellegrini M, Ruocco G, Martini G, Franci B, Campagna MS, Gilleman M, Nuti R,
McCullough PA, Ronco C. Continuous versus bolus intermittent loop diuretic infusion in acutely
decompensated heart failure: a prospective randomized trial. Crit Care. 2014 Jun 28;18(3):R134.
doi: 10.1186/cc13952. PubMed PMID: 24974232.
M425) Manatsathit W, Al-Hamid H, Leelasinjaroen P, Hashmi U, McCullough PA. Management of
gastrointestinal bleeding in patients anticoagulated with dabigatran compared with warfarin: a
retrospective, comparative case review. Cardiovasc Diagn Ther. 2014 Jun;4(3):224-31. doi:
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10.3978/j.issn.2223-3652.2014.03.07. PubMed PMID: 25009791; PubMed Central PMCID:
PMC4069982.
M426) Neath SX, Jefferies JL, Berger JS, Wu AH, McConnell JP, Boone JL, McCullough PA, Jesse RL,
Maisel AS. The current and future landscape of urinary thromboxane testing to evaluate
atherothrombotic risk. Rev Cardiovasc Med. 2014;15(2):119-30. Review. PubMed PMID:
25051129.
M427) Brown JR, Solomon RJ, Sarnak MJ, McCullough PA, Splaine ME, Davies L, Ross CS, Dauerman
HL, Stender JL, Conley SM, Robb JF, Chaisson K, Boss R, Lambert P, Goldberg DJ, Lucier D, Fedele
FA, Kellett MA, Horton S, Phillips WJ, Downs C, Wiseman A, MacKenzie TA, Malenka DJ; for the
Northern New England Cardiovascular Disease Study Group. Reducing Contrast-Induced Acute
Kidney Injury Using a Regional Multicenter Quality Improvement Intervention. Circ Cardiovasc
Qual Outcomes. 2014 Jul 29. pii: CIRCOUTCOMES.114.000903. [Epub ahead of print] PubMed
PMID: 25074372.
M428) Zimering MB, Zhang JH, Guarino PD, Emanuele N, McCullough PA, Fried LF; Investigators for
the VA NEPHRON-D. Endothelial cell autoantibodies in predicting declining renal function, end-
stage renal disease, or death in adult type 2 diabetic nephropathy. Front Endocrinol (Lausanne).
2014 Aug 11;5:128. doi: 10.3389/fendo.2014.00128. eCollection 2014. PubMed PMID:
25157242; PubMed Central PMCID: PMC4127944.
M429) McCullough PA, Kellum JA, Haase M, Müller C, Damman K, Murray PT, Cruz D, House AA,
Schmidt-Ott KM, Vescovo G, Bagshaw SM, Hoste EA, Briguori C, Braam B, Chawla LS, Costanzo
MR, Tumlin JA, Herzog CA, Mehta RL, Rabb H, Shaw AD, Singbartl K, Ronco C. Pathophysiology of
the Cardiorenal Syndromes: Executive Summary from the Eleventh Consensus Conference of the
Acute Dialysis Quality Initiative (ADQI). Blood Purif. 2014;37 Suppl 2:2-13. doi:
10.1159/000361059. Epub 2014 Jul 31. PubMed PMID: 25196564.
M430) Hoste EA, McCullough PA, Kashani K, Chawla LS, Joannidis M, Shaw AD, Feldkamp T,
Uettwiller-Geiger DL, McCarthy P, Shi J, Walker MG, Kellum JA; for the Sapphire Investigators.
Derivation and validation of cutoffs for clinical use of cell cycle arrest biomarkers. Nephrol Dial
Transplant. 2014 Sep 18. pii: gfu292. [Epub ahead of print] PubMed PMID: 25237065.
M431) Chin MP, Wrolstad D, Bakris GL, Chertow GM, de Zeeuw D, Goldsberry A, Linde PG,
McCullough PA, McMurray JJ, Wittes J, Meyer CJ. Risk factors for heart failure in patients with
type 2 diabetes mellitus and stage 4 chronic kidney disease treated with bardoxolone methyl. J
Card Fail. 2014 Dec;20(12):953-8. doi:10.1016/j.cardfail.2014.10.001. Epub 2014 Oct 13.
PubMed PMID: 25307295.
M432) McCullough PA, Fazel P, Choi JW. Screening, diagnosis, and management of CAD in
asymptomatic diabetic patients. JACC Cardiovasc Imaging. 2014 Oct;7(10):1011-2. doi:
10.1016/j.jcmg.2014.08.001. PubMed PMID: 25323163.
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M433) Hundae A, McCullough PA. Cardiac and renal fibrosis in chronic cardiorenal syndromes.
Nephron Clin Pract. 2014;127(1-4):106-12. doi: 10.1159/000363705. Epub 2014 Sep 24. PubMed
PMID: 25343831.
M434) Shin HJ, McCullough PA. Focus on lipids: high-density lipoprotein cholesterol and its
associated lipoproteins in cardiac and renal disease. Nephron Clin Pract. 2014;127(1-4):158-64.
doi: 10.1159/000363552. Epub 2014 Sep 24. PubMed PMID:25343842.
M435) Ball T, McCullough PA. Statins for the prevention of contrast-induced acute kidney injury.
Nephron Clin Pract. 2014;127(1-4):165-71. doi: 10.1159/000363202. Epub 2014 Sep 24. PubMed
PMID: 25343843.
M436) Szczech LA, Stewart RC, Su HL, DeLoskey RJ, Astor BC, Fox CH, McCullough PA, Vassalotti JA.
Primary Care Detection of Chronic Kidney Disease in Adults with Type-2 Diabetes: The ADD-CKD
Study (Awareness, Detection and Drug Therapy in Type 2 Diabetes and Chronic Kidney Disease).
PLoS One. 2014 Nov 26;9(11):e110535. doi: 10.1371/journal.pone.0110535. eCollection 2014.
PubMed PMID: 25427285; PubMed Central PMCID: PMC4245114.
M437) McCullough PA, Roberts WC. Peter Andrew McCullough, MD, MPH: An Interview With the
Editor. Am J Cardiol. 2014 Dec 1;114(11):1772-85. doi: 10.1016/j.amjcard.2014.08.034. Epub
2014 Sep 16. PubMed PMID: 25439453.
M438) Roberts JK, McCullough PA. The Management of Acute Coronary Syndromes in Patients With
Chronic Kidney Disease. Adv Chronic Kidney Dis. 2014 Nov;21(6):472-479. doi:
10.1053/j.ackd.2014.08.005. Epub 2014 Oct 24. Review. PubMed PMID: 25443572.
M439) McCullough PA, Jefferies JL. Novel Markers and Therapies for Patients with Acute Heart
Failure and Renal Dysfunction. Am J Med. 2014 Nov 13. pii: S0002-9343(14)00977-2. doi:
10.1016/j.amjmed.2014.10.035. [Epub ahead of print] PubMed PMID: 25446297.
M440) Ball T, Wheelan K, McCullough PA. Chronic anticoagulation in chronic kidney disease. J Am
Coll Cardiol. 2014 Dec 16;64(23):2483-5. doi: 10.1016/j.jacc.2014.09.052. PubMed PMID:
25500232.
M441) Akrawinthawong K, Ricci J, Cannon L, Dixon S, Kupfer K, Stivers D, Alexander P, David S,
McCullough PA. Subclinical and clinical contrast-induced acute kidney injury: data from a novel
blood marker for determining the risk of developing contrast-induced nephropathy (ENCINO), a
prospective study. Ren Fail. 2014 Dec 18:1-5. [Epub ahead of print] PubMed PMID: 25519207.
M442) McCullough PA, Mehta A, Szerlip H. Improving detection of cardiac surgery-associated acute
kidney injury. J Am Coll Cardiol. 2014 Dec 30;64(25):2763-4. doi: 10.1016/j.jacc.2014.09.065.
PubMed PMID: 25541129.
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M443) Lepor NE, Fouchia DD, McCullough PA. New vistas for the treatment of obesity: turning the
tide against the leading cause of morbidity and cardiovascular mortality in the developed world.
Rev Cardiovasc Med. 2014;15 Suppl 2:S1-19; quiz S20-1. Review. PubMed PMID: 25662755.
M444) Watson KE, Stocker EH, Jacoby DS, McCullough PA. Advanced lipid testing: when, why, and
in whom? Rev Cardiovasc Med. 2014;15(4):310-7; quiz 318-9. Review. PubMed PMID:
25662925.
M445) Charytan DM, Fishbane S, Malyszko J, McCullough PA, Goldsmith D. Cardiorenal Syndrome
and the Role of the Bone-Mineral Axis and Anemia. Am J Kidney Dis. 2015 Feb 26. pii: S0272-
6386(15)00084-0. doi: 10.1053/j.ajkd.2014.12.016. [Epub ahead of print] PubMed PMID:
25727384.
M446) Kassis HM, Minsinger KD, McCullough PA, Block CA, Sidhu MS, Brown JR. A Review of the
Use of Iloprost, A Synthetic Prostacyclin, in the Prevention of Radiocontrast Nephropathy in
Patients Undergoing Coronary Angiography and Intervention. Clin Cardiol. 2015 May 12. doi:
10.1002/clc.22407. [Epub ahead of print] PubMed PMID: 25963191.
M447) Palazzuoli A, McCullough PA, Ronco C, Nuti R. Kidney disease in heart failure: the
importance of novel biomarkers for type 1 cardio-renal syndrome detection. Intern Emerg Med.
2015 May 14. [Epub ahead of print] PubMed PMID: 25972236.
M448) Robinson JG, Farnier M, Krempf M, Bergeron J, Luc G, Averna M, Stroes ES, Langslet G, Raal
FJ, El Shahawy M, Koren MJ, Lepor NE, Lorenzato C, Pordy R, Chaudhari U, Kastelein JJ; ODYSSEY
LONG TERM Investigators (McCullough PA Site PI). Efficacy and safety of alirocumab in reducing
lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1489-99. doi:
10.1056/NEJMoa1501031. Epub 2015 Mar 15. PubMed PMID: 25773378.
M449) McCullough PA, Costanzo MR, Silver M, Spinowitz B, Zhang J, Lepor NE. Novel Agents for the
Prevention and Management of Hyperkalemia. Rev Cardiovasc Med. 2015;16(2):140-55.
PubMed PMID: 26198561.
M450) McCullough PA, Patanker G, Stoler RC. Estimating Renal Filtration, Drug Dosing, and Clinical
Outcomes. J Am Coll Cardiol. 2015 Jun 30;65(25):2724-5. doi: 10.1016/j.jacc.2015.05.015.
PubMed PMID: 26112196.
M451) Husain-Syed F, McCullough PA, Birk HW, Renker M, Brocca A, Seeger W, Ronco C. Cardio-
Pulmonary-Renal Interactions: A Multidisciplinary Approach. J Am Coll Cardiol. 2015 Jun
9;65(22):2433-48. doi: 10.1016/j.jacc.2015.04.024. Review. PubMed PMID: 26046738.
M452) Anker SD, Kosiborod M, Zannad F, Piña IL, McCullough PA, Filippatos G, van der Meer P,
Ponikowski P, Rasmussen HS, Lavin PT, Singh B, Yang A, Deedwania P. Maintenance of serum
potassium with sodium zirconium cyclosilicate (ZS-9) in heart failure patients: results from a
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phase 3 randomized, double-blind, placebo-controlled trial. Eur J Heart Fail. 2015 May 23. doi:
10.1002/ejhf.300. [Epub ahead of print] PubMed PMID: 26011677.
M453) Palazzuoli A, Ruocco G, Ronco C, McCullough PA. Loop diuretics in acute heart failure:
beyond the decongestive relief for the kidney. Crit Care. 2015 Sep 3;19:296. doi:
10.1186/s13054-015-1017-3. PubMed PMID: 26335137; PubMed Central PMCID: PMC4559070.
M454) McCullough PA, Young A, Shutze WP. Acute Kidney Injury After Carotid Artery Stenting. JACC
Cardiovasc Interv. 2015 Sep;8(11):1515-7. doi: 10.1016/j.jcin.2015.07.006. PubMed PMID:
26404205.
M455) Fallahzadeh MK, McCullough PA. Cardiac Electromechanical Abnormalities in Hemodialysis
Patients: Indicators of Cardiomyopathy and Future Risk. Am J Nephrol. 2015;42(3):237-8. doi:
10.1159/000441100. Epub 2015 Oct 20. PubMed PMID: 26484657.
M456) Thompson-Martin Y, McCullough PA, Agrawal V. Impact of an Educational Program for
Advanced Practice Nurses on Knowledge of Kidney Disease Outcomes Quality Initiative
Guidelines. Nephrol Nurs J. 2015 Sep-Oct;42(5):455-60, 496; quiz 461. PubMed PMID:
26591270.
M457) Larsen TR, Singh G, Velocci V, Nasser M, McCullough PA. Frequency of fluid overload and
usefulness of bioimpedance in patients requiring intensive care for sepsis syndromes. Proc (Bayl
Univ Med Cent). 2016 Jan;29(1):12-5. PubMed PMID: 26722156; PubMed Central PMCID:
PMC4677841.
M458) Charytan DM, Foley R, McCullough PA, Rogers JD, Zimetbaum P, Herzog CA, Tumlin JA; MiD
Investigators and Committees. Arrhythmia and Sudden Death in Hemodialysis Patients: Protocol
and Baseline Characteristics of the Monitoring in Dialysis Study. Clin J Am Soc Nephrol. 2016 Jan
13. pii: CJN.09350915. [Epub ahead of print] PubMed PMID: 26763255.
M459) Roberts WC, Hall SA, Ko JM, McCullough PA, Lima B. Atrophy of the Heart After Insertion of
a Left Ventricular Assist Device and Closure of the Aortic Valve. Am J Cardiol. 2016 Mar
1;117(5):878-9. doi: 10.1016/j.amjcard.2015.12.008. Epub 2015 Dec 13. PubMed PMID:
26792135.
M460) Tecson KM, Silver MA, Brune SD, Cauthen C, Kwan MD, Schussler JM, Vasudevan A, Watts JA,
McCullough PA. Impact of Enhanced External Counterpulsation on Heart Failure
Rehospitalization in Patients With Ischemic Cardiomyopathy. Am J Cardiol. 2015 Dec 31. pii:
S0002-9149(15)30069-2. doi: 10.1016/j.amjcard.2015.12.024. [Epub ahead of print] PubMed
PMID: 26813739.
M461) McCullough PA, Roberts WC. Influence of Chronic Renal Failure on Cardiac Structure. J Am
Coll Cardiol. 2016 Mar 15;67(10):1183-5. doi:10.1016/j.jacc.2015.11.065. PubMed PMID:
26965539.
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M462) Palazzuoli A, Ruocco G, Pellegrini M, Beltrami M, Giordano N, Nuti R, McCullough PA.
Prognostic Significance of Hyperuricemia in Patients With Acute Heart Failure. Am J Cardiol.
2016 May 15;117(10):1616-21. doi: 10.1016/j.amjcard.2016.02.039. Epub 2016 Mar 2. PubMed
PMID: 27040576.
M463) McCullough PA, Fallahzadeh MK, Tecson KM. Predicting Acute Kidney Injury in the
Catheterization Laboratory. J Am Coll Cardiol. 2016 Apr 12;67(14):1723-4. doi:
10.1016/j.jacc.2016.02.007. PubMed PMID: 27056779.
M464) Grodzinsky A, Goyal A, Gosch K, McCullough PA, Fonarow GC, Mebazaa A, Masoudi FA,
Spertus JA, Palmer BF, Kosiborod M. Prevalence and Prognosis of Hyperkalemia in Patients with
Acute Myocardial Infarction. Am J Med. 2016 Apr 7. pii:S0002-9343(16)30317-5. doi:
10.1016/j.amjmed.2016.03.008. [Epub ahead of print] PubMed PMID: 27060233.
M465) Sherwood M, McCullough PA. Chronic kidney disease from screening, detection, and
awareness, to prevention. Lancet Glob Health. 2016 May;4(5):e288-9. doi: 10.1016/S2214-
109X(16)30049-3. PubMed PMID: 27102186.
M466) McCullough PA, Afzal A, Kale P. Goal-Directed Heart Failure Care in Patients With Chronic
Kidney Disease and End-Stage Renal Disease. JACC Heart Fail. 2016 May 30. pii: S2213-
1779(16)30084-1. doi: 10.1016/j.jchf.2016.03.014. [Epub ahead of print] PubMed PMID:
27289405.
M467) Prasad A, Sohn A, Morales J, Williams K, Bailey SR, Levin D, McCullough PA, Mehran R,
Lopez-Cruz G, Harder J. Contemporary practice patterns related to the risk of acute kidney injury
in the catheterization laboratory: Results from a survey of Society of Cardiovascular Angiography
and Intervention (SCAI) cardiologists. Catheter Cardiovasc Interv. 2016 Jun 17. doi:
10.1002/ccd.26628. [Epub ahead of print] PubMed PMID: 27315581.
M468) Schussler JM, Vasudevan A, von Bose LJ, Won JI, McCullough PA. Comparative Efficacy of
Transradial Versus Transfemoral Approach for Coronary Angiography and Percutaneous
Coronary Intervention. Am J Cardiol. 2016 Aug 15;118(4):482-8. doi:
10.1016/j.amjcard.2016.05.038. PubMed PMID: 27378143.
M469) Zannad F, Stough WG, Lipicky RJ, Tamargo J, Bakris GL, Borer JS, Alonso García Mde L,
Hadjadj S, Koenig W, Kupfer S, McCullough PA, Mosenzon O, Pocock S, Scheen AJ, Sourij H, Van
der Schueren B, Stahre C, White WB, Calvo G. Assessment of cardiovascular risk of new drugs for
the treatment of diabetes mellitus: risk assessment vs. risk aversion. Eur Heart J Cardiovasc
Pharmacother. 2016 Jul;2(3):200-5. doi: 10.1093/ehjcvp/pvw007. Review. PubMed PMID:
27418973; PubMed Central PMCID: PMC4907355.
M470) McCullough PA, Bennett-Guerrero E, Chawla LS, Beaver T, Mehta RL, Molitoris BA, Eldred A,
Ball G, Lee HJ, Houser MT, Khan S. ABT-719 for the Prevention of Acute Kidney Injury in Patients
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Undergoing High-Risk Cardiac Surgery: A Randomized Phase 2b Clinical Trial. J Am Heart Assoc.
2016 Aug 20;5(8). pii:e003549. doi: 10.1161/JAHA.116.003549. PubMed PMID: 27543797;
PubMed Central PMCID: PMC5015281.
M471) Brown JR, McCullough PA, Matheny ME. Novel Developments in Acute Kidney Injury.
Biomed Res Int. 2016;2016:2756204. doi: 10.1155/2016/2756204. PubMed PMID: 27595099;
PubMed Central PMCID: PMC4995325.
M472) McCullough PA, Choi JP, Feghali GA, Schussler JM, Stoler RM, Vallabahn RC, Mehta A.
Contrast-Induced Acute Kidney Injury. J Am Coll Cardiol. 2016 Sep 27;68(13):1465-73. doi:
10.1016/j.jacc.2016.05.099. Review. PubMed PMID:27659469.
M473) Villa G, Neri M, Bellomo R, Cerda J, De Gaudio AR, De Rosa S, Garzotto F, Honore PM, Kellum
J, Lorenzin A, Payen D, Ricci Z, Samoni S, Vincent JL, Wendon J, Zaccaria M, Ronco C;
Nomenclature Standardization Initiative (NSI) Alliance (McCullough PA member). Nomenclature
for renal replacement therapy and blood purification techniques in critically ill patients: practical
applications. Crit Care. 2016 Oct 10;20(1):283. Review. PubMed PMID: 27719676; PubMed
Central PMCID: PMC5056485.
M474) McCullough PA, Fallahzadeh MK, Hegazi RM. Nutritional Deficiencies and Sarcopenia in
Heart Failure: A Therapeutic Opportunity to Reduce Hospitalization and Death. Rev Cardiovasc
Med. 2016;17(S1):S30-S39. PubMed PMID: 27725625.
M475) Bakris GL, Burkart JM, Weinhandl ED, McCullough PA, Kraus MA. Intensive Hemodialysis,
Blood Pressure, and Antihypertensive Medication Use. Am J Kidney Dis. 2016 Nov;68(5S1):S15-
S23. doi: 10.1053/j.ajkd.2016.05.026. PubMed PMID:27772639.
M476) Copland M, Komenda P, Weinhandl ED, McCullough PA, Morfin JA. Intensive Hemodialysis,
Mineral and Bone Disorder, and Phosphate Binder Use. Am J Kidney Dis. 2016 Nov;68(5S1):S24-
S32. doi: 10.1053/j.ajkd.2016.05.024. PubMed PMID:27772640.
M477) Morfin JA, Fluck RJ, Weinhandl ED, Kansal S, McCullough PA, Komenda P. Intensive
Hemodialysis and Treatment Complications and Tolerability. Am J Kidney Dis. 2016
Nov;68(5S1):S43-S50. doi: 10.1053/j.ajkd.2016.05.021. PubMed PMID:27772642.
M478) McCullough PA, Chan CT, Weinhandl ED, Burkart JM, Bakris GL. Intensive Hemodialysis, Left
Ventricular Hypertrophy, and Cardiovascular Disease. Am J Kidney Dis. 2016 Nov;68(5S1):S5-S14.
doi: 10.1053/j.ajkd.2016.05.025. PubMed PMID: 27772643.
M479) McCullough PA, Ball T, Cox KM, Assar MD. Use of Oral Anticoagulation in the Management
of Atrial Fibrillation in Patients with ESRD: Pro. Clin J Am Soc Nephrol. 2016 Nov 7;11(11):2079-
2084. PubMed PMID: 27797888; PubMed Central PMCID: PMC5108189.
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1;34(5):760-773. doi: 10.1093/ndt/gfz053. PubMed PMID: 30984976.
M548) Rangaswami J, Soman S, McCullough PA. Key Updates in Cardio-Nephrology from 2018:
Springboard to a Bright Future. Cardiorenal Med. 2019 Apr 17;9(4):222-228. doi:
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M549) Zhang J, Rocha NA, McCullough PA. Contribution of ApoCIII to Diabetic Dyslipidemia and
Treatment With Volanesorsen. Rev Cardiovasc Med. 2018 Mar 30;19(1):13-19. doi:
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M550) Tumlin JA, Roy-Chaudhury P, Koplan BA, Costea AI, Kher V, Williamson D, Pokhariyal S,
Charytan DM; MiD investigators and Committees (McCullough PA) . Relationship between
dialytic parameters and reviewer confirmed arrhythmias in hemodialysis patients in the
monitoring in dialysis study. BMC Nephrol. 2019 Mar 5;20(1):80. doi: 10.1186/s12882-019-1212-
6. PubMed PMID: 30836948; PubMed Central PMCID: PMC6402171.
M551) Kluger AY, Tecson KM, Barbin CM, Lee AY, Lerma EV, Rosol ZP, Rangaswami J, Lepor NE,
Cobble ME, McCullough PA. Cardiorenal Outcomes in the CANVAS, DECLARE-TIMI 58, and
EMPA-REG OUTCOME Trials: A Systematic Review. Rev Cardiovasc Med. 2018 Jun 30;19(2):41-
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M552) McCullough PA, Kluger AY, Tecson KM, Barbin CM, Lee AY, Lerma EV, Rosol ZP, Kluger SL,
Rangaswami J. Inhibition of the Sodium-Proton Antiporter (Exchanger) is a Plausible Mechanism
of Potential Benefit and Harm for Drugs Designed to Block Sodium Glucose Co-transporter 2. Rev
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M553) Zanoli L, Lentini P, Briet M, Castellino P, House AA, London GM, Malatino L, McCullough PA,
Mikhailidis DP, Boutouyrie P. Arterial Stiffness in the Heart Disease of CKD. J Am Soc Nephrol.
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M554) House AA, Wanner C, Sarnak MJ, Piña IL, McIntyre CW, Komenda P, Kasiske BL, Deswal A,
deFilippi CR, Cleland JGF, Anker SD, Herzog CA, Cheung M, Wheeler DC, Winkelmayer WC,
McCullough PA; Conference Participants. Heart failure in chronic kidney disease: conclusions
from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference. Kidney
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M555) Sudhakaran S, Bottiglieri T, Tecson KM, Kluger AY, McCullough PA. Alteration of lipid
metabolism in chronic kidney disease, the role of novel antihyperlipidemic agents, and future
directions. Rev Cardiovasc Med. 2018 Sep 30;19(3):77-88. doi: 10.31083/j.rcm.2018.03.908.
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M556) Rangaswami J, Soman S, McCullough PA. Key updates in Cardio-Nephrology from 2018:
springboard to a bright Future. Rev Cardiovasc Med. 2018 Dec 30;19(4):113-116. doi:
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M557) Tecson KM, Hashemi H, Afzal A, Gong TA, Kale P, McCullough PA. Community-Acquired
Acute Kidney Injury as a Risk Factor of de novo Heart Failure Hospitalization. Cardiorenal Med.
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M558) Tumlin JA, Roy-Chaudhury P, Koplan BA, Costea AI, Kher V, Williamson D, Pokhariyal S,
Charytan DM; MiD investigators and Committees (McCullough PA). Relationship between
dialytic parameters and reviewer confirmed arrhythmias in hemodialysis patients in the
monitoring in dialysis study. BMC Nephrol. 2019 Mar 5;20(1):80. doi:10.1186/s12882-019-1212-
6. PubMed PMID: 30836948; PubMed Central PMCID:PMC6402171.
M559) Vijayaraghavan K, McCullough PA, Singh B, Gupta M, Enas E, Mohan V, Misra A, Deedwania
P, Brinton EA; for the Consensus Panel Steering Committee . Cardiometabolic-Renal Disease in
South Asians: Consensus Recommendations from the Cardio Renal Society of America.
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M560) McCullough PA, Mehta HS, Cork DP, Barker CM, Gunnarsson C, Mollenkopf S, Van Houten J,
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M561) Spinowitz BS, Fishbane S, Pergola PE, Roger SD, Lerma EV, Butler J, von Haehling S, Adler SH,
Zhao J, Singh B, Lavin PT, McCullough PA, Kosiborod M, Packham DK; ZS-005 Study Investigators.
Sodium Zirconium Cyclosilicate among Individuals with Hyperkalemia: A 12-Month Phase 3
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M562) Rangaswami J, McCullough PA. Clinical Context of Dyskalemias Across the Heart Failure
Spectrum and Their Associated Adverse Outcomes. JACC Heart Fail. 2019 Jun;7(6):533. doi:
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M563) Ahmad FS, Kallen MA, Schifferdecker KE, Carluzzo KL, Yount SE, Gelow JM, McCullough PA,
Kimmel SE, Fisher ES, Cella D. Development and Initial Validation of the PROMIS®-Plus-HF Profile
Measure. Circ Heart Fail. 2019 Jun;12(6):e005751. doi: 10.1161/CIRCHEARTFAILURE.118.005751.
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M564) Rizk DV, Silva AL, Pergola PE, Toto R, Warnock DG, Chin MP, Goldsberry A, O'Grady M, Meyer
CJ, McCullough PA. Effects of Bardoxolone Methyl on Magnesium in Patients with Type 2
Diabetes Mellitus and Chronic Kidney Disease. Cardiorenal Med. 2019;9(5):316-325. doi:
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M565) Vasudevan A, Choi JW, Feghali GA, Kluger AY, Lander SR, Tecson KM, Sathyamoorthy M,
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M566) Cedars A, Tecson KM, Zaidi AN, Lorts A, McCullough PA. Impact of Durable Ventricular Assist
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M567) Rangaswami J, Bangalore S, Kaplan B, Birdwell KA, Wiseman AC, McCullough PA, Dadhania
DM. Cardiovascular disease care fragmentation in kidney transplantation: a call for action.
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M568) Rossing P, Block GA, Chin MP, Goldsberry A, Heerspink HJL, McCullough PA, Meyer CJ,
Packham D, Pergola PE, Spinowitz B, Sprague SM, Warnock DG, Chertow GM. Effect of
bardoxolone methyl on the urine albumin-to-creatinine ratio in patients with type 2 diabetes
and stage 4 chronic kidney disease. Kidney Int. 2019 May 16. pii: S0085-2538(19)30503-4. doi:
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M569) Kluger AY, Tecson KM, Lee AY, Lerma EV, Rangaswami J, Lepor NE, Cobble ME, McCullough
PA. Class effects of SGLT2 inhibitors on cardiorenal outcomes. Cardiovasc Diabetol. 2019 Aug
5;18(1):99. doi: 10.1186/s12933-019-0903-4. Review. PubMed PMID: 31382965; PubMed
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M570) McCullough PA, Mehta HS, Barker CM, Cork DP, Gunnarsson C, Ryan MP, Baker ER, Van
Houten J, Mollenkopf S, Verta P. The Economic Impact of Mitral Regurgitation on Patients With
Medically Managed Heart Failure. Am J Cardiol. 2019 Oct 15;124(8):1226-1231. doi:
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M571) Singhania G, Ejaz AA, McCullough PA, Kluger AY, Balamuthusamy S, Dass B, Singhania N,
Agarwal A. Continuation of Chronic Heart Failure Therapies During Heart Failure Hospitalization -
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M572) McCullough PA, Ostermann M, Forni LG, Bihorac A, Koyner JL, Chawla LS, Shi J, Kampf JP,
McPherson P, Kellum JA; the Sapphire Investigators. Serial Urinary Tissue Inhibitor of
Metalloproteinase-2 and Insulin-Like Growth Factor-Binding Protein 7 and the Prognosis for
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M573) Husain-Syed F, Birk HW, Ronco C, Schörmann T, Tello K, Richter MJ, Wilhelm J, Sommer N,
Steyerberg E, Bauer P, Walmrath HD, Seeger W, McCullough PA, Gall H, Ghofrani HA. Doppler-
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2019 Nov 5;8(21):e013584. doi: 10.1161/JAHA.119.013584. Epub 2019 Oct 19. PubMed PMID:
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M574) Haq A, McCullough PA. The Promise of next generation sequencing micro RNA for the
discovery of new targets in contrast induced acute kidney injury. Ann Transl Med. 2019
Sep;7(18):424. doi: 10.21037/atm.2019.07.83. PubMed PMID: 31700860; PubMed Central
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M575) Lo KB, Gul F, Ram P, Kluger AY, Tecson KM, McCullough PA, Rangaswami J. The Effects of
SGLT2 Inhibitors on Cardiovascular and Renal Outcomes in Diabetic Patients: A Systematic
Review and Meta-Analysis. Cardiorenal Med. 2020;10(1):1-10. doi: 10.1159/000503919. Epub
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M576) Raju B, McCullough PA. Circulating plasma dipeptidyl dipeptidase 3 and the prognosis of
cardiogenic shock. Eur J Heart Fail. 2020 Feb;22(2):287-289. doi:10.1002/ejhf.1623. Epub 2019
Nov 28. PubMed PMID: 31779037.
M577) Husain-Syed F, Birk HW, Tello K, Richter MJ, Ronco C, McCullough PA, Schörmann T, Ferrari
F, Yücel G, Yazdani B, Walmrath HD, Seeger W, Gall H, Ghofrani HA. Alterations in Doppler-
derived renal venous stasis index during decompensation of right heart failure and fluid
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M578) Weir MR, McCullough PA, Buse JB, Anderson J. Renal and Cardiovascular Effects of Sodium
Glucose Co-Transporter 2 Inhibitors in Patients with Type 2 Diabetes and Chronic Kidney
Disease: Perspectives on the Canagliflozin and Renal Events in Diabetes with Established
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M579) Cork DP, McCullough PA, Mehta HS, Barker CM, Van Houten J, Gunnarsson C, Ryan MP,
Baker ER, Mollenkopf S, Verta P. The economic impact of clinically significant tricuspid
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M580) Xu MX, Teng RL, Ruddy TD, Schoenhagen P, Bartel T, Di Bartolomeo R, Aksoy O, Desai M, von
Kodolitsch Y, Escaned J, McCullough PA, Vasudevan A, Shen CX, Zhao X, Zhou YF, Xu HF, Cheng
XJ, He YM; written on behalf of the AME Interventional Cardiology Collaborative Group. The
CatLet score: a new coronary angiographic scoring tool accommodating the variable coronary
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M582) McCullough PA. Prevention Guidelines as Failed Minimal Standards of Care. Am J Cardiol.
2020 May 1;125(9):1441-1442. doi: 10.1016/j.amjcard.2020.02.001. Epub 2020 Feb 13. PMID:
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M583) Rosol ZP, Kopecky KF, Minehart BR, Tecson KM, Vasudevan A, McCullough PA, Grayburn PA,
Schussler JM. Limitations of transoesophageal echocardiogram in acute ischaemic stroke. Open
Heart. 2020 Mar 24;7(1):e001176. doi: 10.1136/openhrt-2019-001176. PMID: 32257245;
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M584) Lo KB, McCullough PA, Rangaswami J. Antihypertensive drugs and risk of COVID-19? Lancet
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M585) Spertus JA, Jones PG, Maron DJ, O'Brien SM, Reynolds HR, Rosenberg Y, Stone GW, Harrell FE
Jr, Boden WE, Weintraub WS, Baloch K, Mavromatis K, Diaz A, Gosselin G, Newman JD,
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Research Group (McCullough PA, Optimal Medical Management Committee). Health-Status
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M586) Spertus JA, Jones PG, Maron DJ, Mark DB, O'Brien SM, Fleg JL, Reynolds HR, Stone GW, Sidhu
MS, Chaitman BR, Chertow GM, Hochman JS, Bangalore S; ISCHEMIA-CKD Research Group
(McCullough PA Steering Committee). Health Status after Invasive or Conservative Care in
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Senior R, López-Sendón J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS,
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Jeffries NO, Harrell FE Jr, Rockhold FW, Broderick S, Ferguson TB Jr, Williams DO, Harrington RA,
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Management Committee). Initial Invasive or Conservative Strategy for Stable Coronary Disease.
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M588) Bangalore S, Maron DJ, O'Brien SM, Fleg JL, Kretov EI, Briguori C, Kaul U, Reynolds HR,
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Huang Z, Stone GW, Boden WE, Newman JD, Ali ZA, Mark DB, Spertus JA, Alexander KP,
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M589) Packer M, Butler J, Filippatos GS, Jamal W, Salsali A, Schnee J, Kimura K, Zeller C, George J,
Brueckmann M, Anker SD, Zannad F; EMPEROR-Reduced Trial Committees and Investigators
(McCullough PA, Steering Committee). Evaluation of the effect of sodium-glucose co-
transporter 2 inhibition with empagliflozin on morbidity and mortality of patients with chronic
heart failure and a reduced ejection fraction: rationale for and design of the EMPEROR-Reduced
trial. Eur J Heart Fail. 2019 Oct;21(10):1270-1278. doi: 10.1002/ejhf.1536. Epub 2019 Jul 16.
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M590) Anker SD, Butler J, Filippatos GS, Jamal W, Salsali A, Schnee J, Kimura K, Zeller C, George J,
Brueckmann M, Zannad F, Packer M; EMPEROR-Preserved Trial Committees and Investigators
(McCullough PA, Steering Committee). Evaluation of the effects of sodium-glucose co-
transporter 2 inhibition with empagliflozin on morbidity and mortality in patients with chronic
heart failure and a preserved ejection fraction: rationale for and design of the EMPEROR-
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M591) Roger SD, Lavin PT, Lerma EV, McCullough PA, Butler J, Spinowitz BS, von Haehling S,
Kosiborod M, Zhao J, Fishbane S, Packham DK. Long-term safety and efficacy of sodium
zirconium cyclosilicate for hyperkalaemia in patients with mild/moderate versus severe/end-
stage chronic kidney disease: comparative results from an open-label, Phase 3 study. Nephrol
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M592) Oliveros E, Oni ET, Shahzad A, Kluger AY, Lo KB, Rangaswami J, McCullough PA. Benefits and
Risks of Continuing Angiotensin-Converting Enzyme Inhibitors, Angiotensin II Receptor
Antagonists, and Mineralocorticoid Receptor Antagonists during Hospitalizations for Acute Heart
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M593) McCullough PA, Eidt J, Rangaswami J, Lerma E, Tumlin J, Wheelan K, Katz N, Lepor NE, Vijay
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need for individual mobile phone and institutional reporting of at home, hospitalized, and
intensive care unit cases of SARS-CoV-2 (COVID-19) infection. Rev Cardiovasc Med. 2020 Mar
30;21(1):1-7. doi: 10.31083/j.rcm.2020.01.42. PMID: 32259899.
M594) Ronco F, Tarantini G, McCullough PA. Contrast induced acute kidney injury in interventional
cardiology: an update and key guidance for clinicians. Rev Cardiovasc Med. 2020 Mar 30;21(1):9-
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M595) Agrawal A, Virk HUH, Riaz I, Jain D, Tripathi B, Krittanawong C, Bozorgnia B, Figueredo V,
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M596) Kazory A, Ronco C, McCullough PA. SARS-CoV-2 (COVID-19) and intravascular volume
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M598) Lo KB, McCullough PA, Rangaswami J. Mediators of the Effects of Canagliflozin on Heart
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M599) Glenister RT, McCullough PA. Analysing risk in heart failure: a Kalium check. Eur J Heart Fail.
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M600) McCullough PA, Arunthamakun J. Disconnect between community testing and
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M601) Cork DP, McCullough PA, Mehta HS, Barker CM, Gunnarsson C, Ryan MP, Baker ER, Van
Houten J, Mollenkopf S, Verta P. Impact of mitral regurgitation on cardiovascular hospitalization
and death in newly diagnosed heart failure patients. ESC Heart Fail. 2020 Aug;7(4):1502-1509.
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of patients with COVID-19 infection with versus without gastrointestinal symptoms. Proc (Bayl
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M603) Briedis K, Aldujeli A, Aldujeili M, Briede K, Zaliunas R, Hamadeh A, Stoler RC, McCullough PA.
Considerations for Management of Acute Coronary Syndromes During the SARS-CoV-2 (COVID-
19) Pandemic. Am J Cardiol. 2020 Sep 15;131:115-119. doi: 10.1016/j.amjcard.2020.06.039.
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15;131:1-6. doi: 10.1016/j.amjcard.2020.06.063. Epub 2020 Jul 3. PMID: 32732010; PMCID:
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M605) Raju B, Roberts CS, Sathyamoorthy M, Schiffman R, Swift C, McCullough PA. Ventricular
Septal Myectomy for the Treatment of Left Ventricular Outflow Tract Obstruction Due to Fabry
Disease. Am J Cardiol. 2020 Oct 1;132:160-164. doi: 10.1016/j.amjcard.2020.07.020. Epub 2020
Jul 13. PMID: 32773220.
M606) Velasco CE, Suarez NP, Roullard CP, McCullough PA, Roberts WC. Usefulness of coronary
angiography in patients with left atrial myxoma. Proc (Bayl Univ Med Cent). 2020 Jul
6;33(4):529-531. doi: 10.1080/08998280.2020.1776024. PMID: 33100521; PMCID:
PMC7549987.
M607) Gupta S, Hayek SS, Wang W, Chan L, Mathews KS, Melamed ML, Brenner SK, Leonberg-Yoo
A, Schenck EJ, Radbel J, Reiser J, Bansal A, Srivastava A, Zhou Y, Sutherland A, Green A, Shehata
AM, Goyal N, Vijayan A, Velez JCQ, Shaefi S, Parikh CR, Arunthamakun J, Athavale AM, Friedman
AN, Short SAP, Kibbelaar ZA, Abu Omar S, Admon AJ, Donnelly JP, Gershengorn HB, Hernán MA,
Semler MW, Leaf DE; STOP-COVID Investigators (McCullough PA, Site Investigator). Factors
Associated With Death in Critically Ill Patients With Coronavirus Disease 2019 in the US. JAMA
Intern Med. 2020 Jul 15:e203596. doi: 10.1001/jamainternmed.2020.3596. Epub ahead of print.
PMID: 32667668; PMCID: PMC7364338.
M608) Molnar MZ, Bhalla A, Azhar A, Tsujita M, Talwar M, Balaraman V, Sodhi A, Kadaria D, Eason
JD, Hayek SS, Coca SG, Shaefi S, Neyra JA, Gupta S, Leaf DE, Kovesdy CP; STOP-COVID
Investigators (McCullough PA, Site Investigator). Outcomes of critically ill solid organ transplant
patients with COVID-19 in the United States. Am J Transplant. 2020 Nov;20(11):3061-3071. doi:
10.1111/ajt.16280. Epub 2020 Sep 15. PMID: 32844546; PMCID: PMC7460925.
M609) Singhania N, Bansal S, Nimmatoori DP, Ejaz AA, McCullough PA, Singhania G. Current
Overview on Hypercoagulability in COVID-19. Am J Cardiovasc Drugs. 2020 Aug 4:1–11. doi:
10.1007/s40256-020-00431-z. Epub ahead of print. PMID: 32748336; PMCID: PMC7398761.
M610) McCullough PA, Kelly RJ, Ruocco G, Lerma E, Tumlin J, Wheelan KR, Katz N, Lepor NE, Vijay K,
Carter H, Singh B, McCullough SP, Bhambi BK, Palazzuoli A, De Ferrari GM, Milligan GP, Safder T,
Tecson KM, Wang DD, McKinnon JE, O'Neill WW, Zervos M, Risch HA. Pathophysiological Basis
and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection. Am J Med.
2020 Aug 7:S0002-9343(20)30673-2. doi: 10.1016/j.amjmed.2020.07.003. Epub ahead of print.
PMID: 32771461; PMCID: PMC7410805.
M611) Raal FJ, Rosenson RS, Reeskamp LF, Hovingh GK, Kastelein JJP, Rubba P, Ali S, Banerjee P,
Chan KC, Gipe DA, Khilla N, Pordy R, Weinreich DM, Yancopoulos GD, Zhang Y, Gaudet D; ELIPSE
HoFH Investigators (McCullough PA Site Investigator). Evinacumab for Homozygous Familial
Hypercholesterolemia. N Engl J Med. 2020 Aug 20;383(8):711-720. doi:
10.1056/NEJMoa2004215. PMID: 32813947.
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M612) Elsaid O, McCullough PA, Tecson KM, Williams RS, Yoon A. Ventricular Fibrillation Storm in
Coronavirus 2019. Am J Cardiol. 2020 Aug 29:S0002-9149(20)30890-0. doi:
10.1016/j.amjcard.2020.08.033. Epub ahead of print. PMID: 32871109; PMCID: PMC7455792.
M613) Goyal A, Lo KB, Chatterjee K, Mathew RO, McCullough PA, Bangalore S, Rangaswami J. Acute
coronary syndromes in the peri-operative period after kidney transplantation in United States.
Clin Transplant. 2020 Sep 18:e14083. doi: 10.1111/ctr.14083. Epub ahead of print. PMID:
32946629.
M614) Palazzuoli A, Ruberto F, De Ferrari GM, Forleo G, Secco GG, Ruocco GM, D'Ascenzo F, Mojoli
F, Monticone S, Paggi A, Vicenzi M, Corcione S, Palazzo AG, Landolina M, Taravelli E, Tavazzi G,
Blasi F, Mancone M, Birtolo LI, Alessandri F, Infusino F, Pugliese F, Fedele F, De Rosa FG, Emmett
M, Schussler JM, McCullough PA, Tecson KM. Inpatient Mortality According to Level of
Respiratory Support Received for Severe Acute Respiratory Syndrome Coronavirus 2
(Coronavirus Disease 2019) Infection: A Prospective Multicenter Study. Crit Care Explor. 2020
Sep 18;2(9):e0220. doi: 10.1097/CCE.0000000000000220. PMID: 32984838; PMCID:
PMC7505344.
M615) McCullough PA. Favipiravir and the Need for Early Ambulatory Treatment of SARS-CoV-2
Infection (COVID-19). Antimicrob Agents Chemother. 2020 Nov 17;64(12):e02017-20. doi:
10.1128/AAC.02017-20. PMID: 32967849; PMCID: PMC7674042.
M616) Rangaswami J, Bhalla V, de Boer IH, Staruschenko A, Sharp JA, Singh RR, Lo KB, Tuttle K,
Vaduganathan M, Ventura H, McCullough PA; American Heart Association Council on the Kidney
in Cardiovascular Disease; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council
on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; and Council on Lifestyle
and Cardiometabolic Health. Cardiorenal Protection With the Newer Antidiabetic Agents in
Patients With Diabetes and Chronic Kidney Disease: A Scientific Statement From the American
Heart Association. Circulation. 2020 Sep 28:CIR0000000000000920. doi:
10.1161/CIR.0000000000000920. Epub ahead of print. PMID: 32981345.
M617) Ruocco G, McCullough PA, Tecson KM, Mancone M, De Ferrari GM, D'Ascenzo F, De Rosa
FG, Paggi A, Forleo G, Secco GG, Pistis G, Monticone S, Vicenzi M, Rota I, Blasi F, Pugliese F,
Fedele F, Palazzuoli A. Mortality Risk Assessment Using CHA(2)DS(2)-VASc Scores in Patients
Hospitalized With Coronavirus Disease 2019 Infection. Am J Cardiol. 2020 Sep 28:S0002-
9149(20)31004-3. doi: 10.1016/j.amjcard.2020.09.029. Epub ahead of print. PMID: 32991860;
PMCID: PMC7521434.
M618) Hayek SS, Brenner SK, Azam TU, Shadid HR, Anderson E, Berlin H, Pan M, Meloche C, Feroz R,
O'Hayer P, Kaakati R, Bitar A, Padalia K, Perry D, Blakely P, Gupta S, Shaefi S, Srivastava A,
Charytan DM, Bansal A, Mallappallil M, Melamed ML, Shehata AM, Sunderram J, Mathews KS,
Sutherland AK, Nallamothu BK, Leaf DE; STOP-COVID Investigators (McCullough PA Site
Investigator). In-hospital cardiac arrest in critically ill patients with covid-19: multicenter cohort
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study. BMJ. 2020 Sep 30;371:m3513. doi: 10.1136/bmj.m3513. PMID: 32998872; PMCID:
PMC7525342.
M619) Lo KB, Bhargav R, Salacup G, Pelayo J, Albano J, McCullough PA, Rangaswami J. Angiotensin
converting enzyme inhibitors and angiotensin II receptor blockers and outcomes in patients with
COVID-19: a systematic review and meta-analysis. Expert Rev Cardiovasc Ther. 2020 Oct 5:1-12.
doi: 10.1080/14779072.2020.1826308. Epub ahead of print. PMID: 32945216.
M620) Palazzuoli A, Mancone M, De Ferrari GM, Forleo G, Secco GG, Ruocco GM, D'Ascenzo F,
Monticone S, Paggi A, Vicenzi M, Palazzo AG, Landolina M, Taravelli E, Tavazzi G, Blasi F, Infusino
F, Fedele F, De Rosa FG, Emmett M, Schussler JM, Tecson KM, McCullough PA. Antecedent
Administration of Angiotensin Converting Enzyme Inhibitors or Angiotensin II Receptor
Antagonists and Survival After Hospitalization for SARS-CoV-2 (COVID-19). J Am Heart Assoc.
2020 Oct 7:e017364. doi: 10.1161/JAHA.120.017364. Epub ahead of print. PMID: 33023356.
M621) Zhang J, Tecson KM, McCullough PA. Endothelial dysfunction contributes to COVID-19-
associated vascular inflammation and coagulopathy. Reviews in Cardiovascular Medicine, 2020,
21(3): 315-319. DOI: 10.31083/j.rcm.2020.03.126
https://rcm.imrpress.com/EN/10.31083/j.rcm.2020.03.126
M622) Zhang J, McCullough PA, Tecson KM. Vitamin D deficiency in association with endothelial
dysfunction: Implications for patients with COVID-19. Reviews in Cardiovascular Medicine, 2020,
21(3): 339-344. DOI: 10.31083/j.rcm.2020.03.131
https://rcm.imrpress.com/EN/10.31083/j.rcm.2020.03.131
M623) McCullough PA Innovative Early Sequenced Multidrug Therapy for Sars-Cov-2 (Covid-19)
Infection to Reduce Hospitalization and Death International Journal of Medical Science and
Clinical Invention7(12): 5139-5150, 2020 DOI:10.18535/ijmsci/v7i12.02
M624) Flythe JE, Assimon MM, Tugman MJ, Chang EH, Gupta S, Shah J, Sosa MA, Renaghan AD,
Melamed ML, Wilson FP, Neyra JA, Rashidi A, Boyle SM, Anand S, Christov M, Thomas LF,
Edmonston D, Leaf DE; STOP-COVID Investigators (McCullough PA Site Investigator).
Characteristics and Outcomes of Individuals With Pre-existing Kidney Disease and COVID-19
Admitted to Intensive Care Units in the United States. Am J Kidney Dis. 2020 Sep 19:S0272-
6386(20)30999-9. doi: 10.1053/j.ajkd.2020.09.003. Epub ahead of print. PMID: 32961244;
PMCID: PMC7501875.
M625) Gupta S, Coca SG, Chan L, Melamed ML, Brenner SK, Hayek SS, Sutherland A, Puri S,
Srivastava A, Leonberg-Yoo A, Shehata AM, Flythe JE, Rashidi A, Schenck EJ, Goyal N, Hedayati
SS, Dy R, Bansal A, Athavale A, Nguyen HB, Vijayan A, Charytan DM, Schulze CE, Joo MJ,
Friedman AN, Zhang J, Sosa MA, Judd E, Velez JCQ, Mallappallil M, Redfern RE, Bansal AD, Neyra
JA, Liu KD, Renaghan AD, Christov M, Molnar MZ, Sharma S, Kamal O, Boateng JO, Short SAP,
Admon AJ, Sise ME, Wang W, Parikh CR, Leaf DE; STOP-COVID Investigators (McCullough PA Site
Investigator). AKI Treated with Renal Replacement Therapy in Critically Ill Patients with COVID-
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19. J Am Soc Nephrol. 2020 Oct 16:ASN.2020060897. doi: 10.1681/ASN.2020060897. Epub
ahead of print. PMID: 33067383.
M626) Gupta S, Wang W, Hayek SS, Chan L, Mathews KS, Melamed ML, Brenner SK, Leonberg-Yoo
A, Schenck EJ, Radbel J, Reiser J, Bansal A, Srivastava A, Zhou Y, Finkel D, Green A, Mallappallil
M, Faugno AJ, Zhang J, Velez JCQ, Shaefi S, Parikh CR, Charytan DM, Athavale AM, Friedman AN,
Redfern RE, Short SAP, Correa S, Pokharel KK, Admon AJ, Donnelly JP, Gershengorn HB, Douin
DJ, Semler MW, Hernán MA, Leaf DE; STOP-COVID Investigators (McCullough PA Site
Investigator). Association Between Early Treatment With Tocilizumab and Mortality Among
Critically Ill Patients With COVID-19. JAMA Intern Med. 2020 Oct 20:e206252. doi:
10.1001/jamainternmed.2020.6252. Epub ahead of print. PMID: 33080002; PMCID:
PMC7577201.
M627) Chertow GM, Pergola PE, Agarwal R, Block GA, Farag YMK, Jardine AG, Koury MJ, Luo W,
Khawaja Z, Lewis EF, Matsushita K, McCullough PA, Parfrey PS, Wittes J, Walters KA, Tseng C, Lin
T, Sarnak MJ, Vargo DL, Winkelmayer WC, Eckardt KU. Cardiovascular Safety and Efficacy of
Vadadustat for the Treatment of Anemia in Non-Dialysis Dependent CKD: Design and Baseline
Characteristics. Am Heart J. 2020 Oct 29:S0002-8703(20)30354-9. doi:
10.1016/j.ahj.2020.10.068. Epub ahead of print. PMID: 33129989.
M628) McCullough PA, Goldstein JA. A novel strategy to prevent contrast nephropathy:
"Continuous hemodiafiltration". Catheter Cardiovasc Interv. 2020 Nov;96(6):1182-1183. doi:
10.1002/ccd.29356. PMID: 33217180.
M629) Aldujeli A, Hamadeh A, Briedis K, Tecson KM, Rutland J, Krivickas Z, Stiklioraitis S, Briede K,
Aldujeili M, Unikas R, Zaliaduonyte D, Zaliunas R, Vallabhan RC, McCullough PA. Delays in
Presentation in Patients With Acute Myocardial Infarction During the COVID-19 Pandemic.
Cardiol Res. 2020 Dec;11(6):386-391. doi: 10.14740/cr1175. Epub 2020 Nov 2. PMID: 33224384;
PMCID: PMC7666599.
M630) Barker CM, Cork DP, McCullough PA, Mehta HS, Houten JV, Gunnarsson C, Mollenkopf S,
Verta P. Healthcare utilization in clinically significant tricuspid regurgitation patients with and
without heart failure. J Comp Eff Res. 2020 Nov 11. doi: 10.2217/cer-2020-0198. Epub ahead of
print. PMID: 33174767.
M631) Eckardt KU, Agarwal R, Farag YM, Jardine AG, Khawaja Z, Koury MJ, Luo W, Matsushita K,
McCullough PA, Parfrey P, Ross G, Sarnak MJ, Vargo D, Winkelmayer WC, Chertow GM. Global
Phase 3 programme of vadadustat for treatment of anaemia of chronic kidney disease:
rationale, study design and baseline characteristics of dialysis-dependent patients in the
INNO2VATE trials. Nephrol Dial Transplant. 2020 Nov 14:gfaa204. doi: 10.1093/ndt/gfaa204.
Epub ahead of print. PMID: 33188693.
M632) Rahimi G, Tecson KM, Elsaid O, McCullough PA. Role of Ischemic Heart Disease in Major
Adverse Renal and Cardiac Events Among Individuals With Heart Failure With Preserved Ejection
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Fraction (from the TOPCAT Trial). Am J Cardiol. 2020 Dec 3:S0002-9149(20)31296-0. doi:
10.1016/j.amjcard.2020.11.034. Epub ahead of print. PMID: 33279481.
M633) Roger SD, Lavin PT, Lerma EV, McCullough PA, Butler J, Spinowitz BS, von Haehling S,
Kosiborod M, Zhao J, Fishbane S, Packham DK. Long-term safety and efficacy of sodium
zirconium cyclosilicate for hyperkalaemia in patients with mild/moderate versus severe/end-
stage chronic kidney disease: comparative results from an open-label, Phase 3 study. Nephrol
Dial Transplant. 2021 Jan 1;36(1):137-150. doi: 10.1093/ndt/gfz285. PMID: 32030422.
M634) McCullough PA, Oskoui R. Early multidrug regimens in new potentially fatal medical
problems. Rev Cardiovasc Med. 2020 Dec 30;21(4):507-508. doi: 10.31083/j.rcm.2020.04.270.
PMID: 33387995.
M635) McCullough PA, Alexander PE, Armstrong R, Arvinte C, Bain AF, Bartlett RP, Berkowitz RL,
Berry AC, Borody TJ, Brewer JH, Brufsky AM, Clarke T, Derwand R, Eck A, Eck J, Eisner RA, Fareed
GC, Farella A, Fonseca SNS, Geyer CE Jr, Gonnering RS, Graves KE, Gross KBV, Hazan S, Held KS,
Hight HT, Immanuel S, Jacobs MM, Ladapo JA, Lee LH, Littell J, Lozano I, Mangat HS, Marble B,
McKinnon JE, Merritt LD, Orient JM, Oskoui R, Pompan DC, Procter BC, Prodromos C, Rajter JC,
Rajter JJ, Ram CVS, Rios SS, Risch HA, Robb MJA, Rutherford M, Scholz M, Singleton MM, Tumlin
JA, Tyson BM, Urso RG, Victory K, Vliet EL, Wax CM, Wolkoff AG, Wooll V, Zelenko V.
Multifaceted highly targeted sequential multidrug treatment of early ambulatory high-risk SARS-
CoV-2 infection (COVID-19). Rev Cardiovasc Med. 2020 Dec 30;21(4):517-530. doi:
10.31083/j.rcm.2020.04.264. PMID: 33387997.
M636) Procter BC, Ross C, Pickard V, Smith E, Hanson C, McCullough PA. Clinical outcomes after
early ambulatory multidrug therapy for high-risk SARS-CoV-2 (COVID-19) infection. Rev
Cardiovasc Med. 2020 Dec 30;21(4):611-614. doi: 10.31083/j.rcm.2020.04.260. PMID:
33388006.
M637) Gupta S, Wang W, Hayek SS, Chan L, Mathews KS, Melamed ML, Brenner SK, Leonberg-Yoo
A, Schenck EJ, Radbel J, Reiser J, Bansal A, Srivastava A, Zhou Y, Finkel D, Green A, Mallappallil
M, Faugno AJ, Zhang J, Velez JCQ, Shaefi S, Parikh CR, Charytan DM, Athavale AM, Friedman AN,
Redfern RE, Short SAP, Correa S, Pokharel KK, Admon AJ, Donnelly JP, Gershengorn HB, Douin
DJ, Semler MW, Hernán MA, Leaf DE; STOP-COVID Investigators. (McCullough PA Site
Investigator). Association Between Early Treatment With Tocilizumab and Mortality Among
Critically Ill Patients With COVID-19. JAMA Intern Med. 2021 Jan 1;181(1):41-51. doi:
10.1001/jamainternmed.2020.6252. PMID: 33080002; PMCID: PMC7577201.
M638) Palazzuoli A, Ruocco G, Tecson KM, McCullough PA. Screening, detection, and management
of heart failure in the SARS-CoV2 (COVID-19) pandemic. Heart Fail Rev. 2021 Jan 6:1–7. doi:
10.1007/s10741-020-10068-4. Epub ahead of print. PMID: 33405001; PMCID: PMC7786335.
M639) Al-Samkari H, Gupta S, Leaf RK, Wang W, Rosovsky RP, Brenner SK, Hayek SS, Berlin H,
Kapoor R, Shaefi S, Melamed ML, Sutherland A, Radbel J, Green A, Garibaldi BT, Srivastava A,
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Leonberg-Yoo A, Shehata AM, Flythe JE, Rashidi A, Goyal N, Chan L, Mathews KS, Hedayati SS, Dy
R, Toth-Manikowski SM, Zhang J, Mallappallil M, Redfern RE, Bansal AD, Short SAP, Vangel MG,
Admon AJ, Semler MW, Bauer KA, Hernán MA, Leaf DE; STOP-COVID-19 Investigators
(McCullough PA Site Investigator). Thrombosis, Bleeding, and the Observational Effect of Early
Therapeutic Anticoagulation on Survival in Critically Ill Patients With COVID-19. Ann Intern Med.
2021 Jan 26:M20-6739. doi: 10.7326/M20-6739. Epub ahead of print. PMID: 33493012; PMCID:
PMC7863679.
M640) Zhang J, Tecson KM, McCullough PA. Role of endothelial cell receptors in the context of
SARS-CoV-2 infection (COVID-19). Proc (Bayl Univ Med Cent). 2021 Jan 26;34(2):262-268. doi:
10.1080/08998280.2021.1874231. PMID: 33664552; PMCID: PMC7852287.
M641) Shaefi S, Brenner SK, Gupta S, O'Gara BP, Krajewski ML, Charytan DM, Chaudhry S, Mirza SH,
Peev V, Anderson M, Bansal A, Hayek SS, Srivastava A, Mathews KS, Johns TS, Leonberg-Yoo A,
Green A, Arunthamakun J, Wille KM, Shaukat T, Singh H, Admon AJ, Semler MW, Hernán MA,
Mueller AL, Wang W, Leaf DE; STOP-COVID Investigators (McCullough PA Site Investigator).
Extracorporeal membrane oxygenation in patients with severe respiratory failure from COVID-
19. Intensive Care Med. 2021 Feb;47(2):208-221. doi: 10.1007/s00134-020-06331-9. Epub 2021
Feb 2. PMID: 33528595; PMCID: PMC7851810.
M642) Short SAP, Gupta S, Brenner SK, Hayek SS, Srivastava A, Shaefi S, Singh H, Wu B, Bagchi A, Al-
Samkari H, Dy R, Wilkinson K, Zakai NA, Leaf DE; STOP-COVID Investigators(McCullough PA Site
Investigator). D-dimer and Death in Critically Ill Patients With Coronavirus Disease 2019. Crit
Care Med. 2021 Feb 12. doi: 10.1097/CCM.0000000000004917. Epub ahead of print. PMID:
33591017.
M643) Mathews KS, Soh H, Shaefi S, Wang W, Bose S, Coca S, Gupta S, Hayek SS, Srivastava A,
Brenner SK, Radbel J, Green A, Sutherland A, Leonberg-Yoo A, Shehata A, Schenck EJ, Short SAP,
Hernán MA, Chan L, Leaf DE; Study of the Treatment and Outcomes in Critically Ill Patients with
Coronavirus Disease (STOP-COVID) Investigators(McCullough PA Site Investigator). Prone
Positioning and Survival in Mechanically Ventilated Patients With Coronavirus Disease 2019-
Related Respiratory Failure. Crit Care Med. 2021 Feb 17. doi: 10.1097/CCM.0000000000004938.
Epub ahead of print. PMID: 33595960.
M644) Aldujeli A, Hamadeh A, Tecson KM, Krivickas Z, Maciulevicius L, Stiklioraitis S, Sukys M,
Briedis K, Aldujeili M, Briede K, Braukyliene R, Pranculis A, Unikas R, Zaliaduonyte D, McCullough
PA. Six-Month Outcomes for COVID-19 Negative Patients with Acute Myocardial Infarction
Before Versus During the COVID-19 Pandemic. Am J Cardiol. 2021 Feb 23:S0002-9149(21)00161-
2. doi: 10.1016/j.amjcard.2021.01.043. Epub ahead of print. PMID: 33631113; PMCID:
PMC7900754.
M645) McCullough PA, Rahimi G, Tecson KM. Ambulatory Worsening of Renal Function in Heart
Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2021 Mar 9;77(9):1222-1224. doi:
10.1016/j.jacc.2021.01.007. PMID: 33663740.
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M646) Kalantar-Zadeh K, McCullough PA, Agarwal SK, Beddhu S, Boaz M, Bruchfeld A, Chauveau P,
Chen J, de Sequera P, Gedney N, Golper TA, Gupta M, Harris T, Hartwell L, Liakopoulos V, Kopple
JD, Kovesdy CP, Macdougall IC, Mann JFE, Molony D, Norris KC, Perlmutter J, Rhee CM, Riella LV,
Weisbord SD, Zoccali C, Goldsmith D. Nomenclature in nephrology: preserving 'renal' and
'nephro' in the glossary of kidney health and disease. J Nephrol. 2021 Mar 13. doi:
10.1007/s40620-021-01011-3. Epub ahead of print. PMID: 33713333.
M647) McCullough PA. Anemia of cardiorenal syndrome. Kidney Int Suppl (2011). 2021
Apr;11(1):35-45. doi: 10.1016/j.kisu.2020.12.001. Epub 2021 Mar 18. PMID: 33777494; PMCID:
PMC7983020.
M648) Lo KB, Toroghi HM, Salacup G, Jiang J, Bhargav R, Quintero E, Balestrini K, Shahzad A,
Mathew RO, McCullough PA, Rangaswami J. Angiotensin converting enzyme inhibitors and
angiotensin receptor blockers in acute heart failure: invasive hemodynamic parameters and
clinical outcomes. Rev Cardiovasc Med. 2021 Mar 30;22(1):199-206. doi:
10.31083/j.rcm.2021.01.216. PMID: 33792263.
M649) Kellum JA, Artigas A, Gunnerson KJ, Honore PM, Kampf JP, Kwan T, McPherson P, Nguyen
HB, Rimmelé T, Shapiro NI, Shi J, Vincent JL, Chawla LS; Sapphire Investigators (McCullough PA
Site Investigator). Use of Biomarkers to Identify Acute Kidney Injury to Help Detect Sepsis in
Patients With Infection. Crit Care Med. 2021 Apr 1;49(4):e360-e368. doi:
10.1097/CCM.0000000000004845. PMID: 33566467; PMCID: PMC7963439.
M650) Procter BC, Ross C, Pickard V, Smith E, Hanson C, McCullough PA. Early Ambulatory
Multidrug Therapy Reduces Hospitalization and Death in High-Risk Patients with SARS-CoV-2
(COVID-19). ijirms [Internet]. 2021Mar.17 [cited 2021Apr.28];6(03):219 - 221.
https://www.ijirms.in/index.php/ijirms/article/view/1100,
https://www.ijirms.in/index.php/ijirms/article/view/1100#downloadTab
M651) McCullough PA, Vijay K. SARS-CoV-2 infection and the COVID-19 pandemic: a call to action
for therapy and interventions to resolve the crisis of hospitalization, death, and handle the
aftermath. Rev Cardiovasc Med. 2021 Mar 30;22(1):9-10. doi: 10.31083/j.rcm.2021.01.301.
PMID: 33792243.
M652) Valdenor C, McCullough PA, Paculdo D, Acelajado MC, Dahlen JR, Noiri E, Sugaya T, Peabody
J. Measuring the Variation in the Prevention and Treatment of CI-AKI Among Interventional
Cardiologists. Curr Probl Cardiol. 2021 Apr 3:100851. doi: 10.1016/j.cpcardiol.2021.100851.
Epub ahead of print. PMID: 33994040.
M653) Ishida JH, Chauhan C, Gillespie B, Gruchalla K, McCullough PA, Quella S, Romero A, Rossignol
P, Wheeler DC, Malley MA, West M, Herzog CA. Understanding and Overcoming the Challenges
Related to Cardiovascular Trials Involving Patients with Kidney Disease. Clin J Am Soc Nephrol.
2021 Apr 23:CJN.17561120. doi: 10.2215/CJN.17561120. Epub ahead of print. PMID: 33893163.
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M654) Chertow GM, Pergola PE, Farag YMK, Agarwal R, Arnold S, Bako G, Block GA, Burke S, Castillo
FP, Jardine AG, Khawaja Z, Koury MJ, Lewis EF, Lin T, Luo W, Maroni BJ, Matsushita K,
McCullough PA, Parfrey PS, Roy-Chaudhury P, Sarnak MJ, Sharma A, Spinowitz B, Tseng C,
Tumlin J, Vargo DL, Walters KA, Winkelmayer WC, Wittes J, Eckardt KU; PRO2TECT Study Group.
Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD. N Engl J Med. 2021 Apr
29;384(17):1589-1600. doi: 10.1056/NEJMoa2035938. PMID: 33913637.
M655) Eckardt KU, Agarwal R, Aswad A, Awad A, Block GA, Bacci MR, Farag YMK, Fishbane S, Hubert
H, Jardine A, Khawaja Z, Koury MJ, Maroni BJ, Matsushita K, McCullough PA, Lewis EF, Luo W,
Parfrey PS, Pergola P, Sarnak MJ, Spinowitz B, Tumlin J, Vargo DL, Walters KA, Winkelmayer WC,
Wittes J, Zwiech R, Chertow GM. Safety and Efficacy of Vadadustat for Anemia in Patients
Undergoing Dialysis. N Engl J Med. 2021 Apr 29;384(17):1601-1612. doi:
10.1056/NEJMoa2025956. PMID: 33913638.
M656) Short SAP, Gupta S, Brenner SK, Hayek SS, Srivastava A, Shaefi S, Singh H, Wu B, Bagchi A, Al-
Samkari H, Dy R, Wilkinson K, Zakai NA, Leaf DE; STOP-COVID Investigators (McCullough PA Site
Investigator). d-dimer and Death in Critically Ill Patients With Coronavirus Disease 2019. Crit
Care Med. 2021 May 1;49(5):e500-e511. doi: 10.1097/CCM.0000000000004917. PMID:
33591017.
M657) Swolinsky JS, Nerger NP, Leistner DM, Edelmann F, Knebel F, Tuvshinbat E, Lemke C, Roehle
R, Haase M, Costanzo MR, Rauch G, Mitrovic V, Gasanin E, Meier D, McCullough PA, Eckardt KU,
Molitoris BA, Schmidt-Ott KM. Serum creatinine and cystatin C-based estimates of glomerular
filtration rate are misleading in acute heart failure. ESC Heart Fail. 2021 May 6. doi:
10.1002/ehf2.13404. Epub ahead of print. PMID: 33955699.
M658) Palazzuoli A, Tecson KM, Ronco C, McCullough PA. Nomenclature for Kidney Function from
KDIGO: Shortcomings of Terminology Oversimplification. Cardiorenal Med. 2021 Jun 4:1-4. doi:
10.1159/000516615. Epub ahead of print. PMID: 34091445.
M659) Vasquez CR, Gupta S, Miano TA, Roche M, Hsu J, Yang W, Holena DN, Reilly JP, Schrauben SJ,
Leaf DE, Shashaty MGS; STOP-COVID Investigators (McCullough PA Site Investigator).
Identification of Distinct Clinical Subphenotypes in Critically Ill Patients With COVID-19. Chest.
2021 May 6:S0012-3692(21)00874-6. doi: 10.1016/j.chest.2021.04.062. Epub ahead of print.
PMID: 33964301; PMCID: PMC8099539.
M660) Alexander PE, Armstrong R, Fareed G, Lotus J, Oskoui R, Prodromos C, Risch HA, Tenenbaum
HC, Wax CM, Dara P, McCullough PA, Gill KK. Early multidrug treatment of SARS-CoV-2 infection
(COVID-19) and reduced mortality among nursing home (or outpatient/ambulatory) residents.
Med Hypotheses. 2021 Jun 5;153:110622. doi: 10.1016/j.mehy.2021.110622. Epub ahead of
print. PMID: 34130113; PMCID: PMC8178530.
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M661) Mathews KS, Soh H, Shaefi S, Wang W, Bose S, Coca S, Gupta S, Hayek SS, Srivastava A,
Brenner SK, Radbel J, Green A, Sutherland A, Leonberg-Yoo A, Shehata A, Schenck EJ, Short SAP,
Hernán MA, Chan L, Leaf DE; STOP-COVID Investigators (McCullough PA Site Investigator) .
Prone Positioning and Survival in Mechanically Ventilated Patients With Coronavirus Disease
2019-Related Respiratory Failure. Crit Care Med. 2021 Jul 1;49(7):1026-1037. doi:
10.1097/CCM.0000000000004938. PMID: 33595960; PMCID: PMC8277560.
M662) McCullough PA, Mehta HS, Barker CM, Houten JV, Mollenkopf S, Gunnarsson C, Ryan M,
Cork DP. Healthcare utilization and guideline-directed medical therapy in heart failure patients
with reduced ejection fraction. J Comp Eff Res. 2021 Jul 6. doi: 10.2217/cer-2021-0118. Epub
ahead of print. PMID: 34225473.
M663) Palazzuoli A, Tecson KM, McCullough PA. Impact of renin-angiotensin-aldosterone system
inhibitor continuation on outcomes for patients with severe coronavirus disease 2019
manifestations. J Hypertens. 2021 Aug 1;39(8):1725-1726. doi:
10.1097/HJH.0000000000002876. PMID: 34188007.
M664) McCullough PA, Mehta HS, Barker CM, Van Houten J, Mollenkopf S, Gunnarsson C, Ryan M,
Cork DP. Mortality and guideline-directed medical therapy in real-world heart failure patients
with reduced ejection fraction. Clin Cardiol. 2021 Aug 3. doi: 10.1002/clc.23664. Epub ahead of
print. PMID: 34342033.
Published Letters
ltr1)
McCullough PA, O'Neill WW. Letter to the Editor: Regional Variation Across the United
States in the Management of Acute Myocardial Infarction. New Engl J Med 1996;334:194;
discussion 194-5. PMID: 96127997
ltr2)
McCullough PA, O’Neill WW. Letter to the Editor: Patient care after percutaneous coronary
artery interventions. Ann Intern Med 1998 Apr 1;128:598; discussion 599-600. PMID: 98175287
ltr3)
McCullough PA, Redle JD. Letter to the Editor: Amiodarone Prophylaxis for Atrial Fibrillation
after Bypass Surgery. New Engl J Med 1998;338:1383; discussion 1384. PMID: 98223116
ltr4)
Sharma ND, McCullough PA. Letter to the Editor: Predictability of left ventricular thrombus
by mitral regurgitation. Am Heart J 1999 Feb;137(2):373-5. PMID: 99156058
ltr5)
McCullough PA, Marks KR. Letter to the Editor: Ticlopidine and TTP after Coronary Stenting.
JAMA 1999;282(18):1717-1718;discussion 1718-9. PMID: 10568636
ltr6)
McCullough PA, Sandberg KR, Thompson RJ. Letter to the Editor: Predicting Outcomes after
Cardiopulmonary Resuscitation. Arch Intern Med 2001;161(4):615-616. PMID: 11252131
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ltr7)
McCullough PA. Letter to the Editor: The Anti-inflammatory Effect of Statins. N Engl J Med.
2001 Oct 18;345(16):1209; discussion 1210-1. PMID: 11642241
ltr8)
McCullough PA, Sandberg KR, Borzak S. Letter to the Editor: Cardiovascular outcomes and
renal disease. Ann Intern Med. 2002 Apr 16;136(8):633-4; discussion 633-4. PMID: 11955038
ltr9)
McCullough PA. Reply to Manhapra A, Why is chronic kidney disease the "spoiler" for
cardiovascular outcomes: an alternate take from a generalist. J Am Coll Cardiol. 2004 Mar
3;43(5):924; author reply 924-5. PMID: 15006584
ltr10) Omland T, Knudsen CW, McCullough PA, Maisel AS. Response to LTE. #2005-624 - Schwam.
Ann Emerg Med. 2006 Feb;47(2):214. PMID: 16431243
ltr11) Barker D, Artis N, Tan LB, DeJong A, Franklin BA, McCullough PA. Correcting data for body
size may confound results. Chest. 2006 Feb;129(2):493-4. PMID: 16478872
ltr12) McCullough PA. Failure of beta-blockers in the reduction of perioperative events: Where did
we go wrong? Response to the letter to the Editor by Souza et al. Am Heart J. 2007
Jun;153(6):e39. PMID: 17540183
ltr13) McCullough PA. Multimodality prevention of contrast-induced acute kidney injury, In Reply.
Am J Kidney Dis. 2008 Jun;51(6):1068-1069. PMID: 18501789
ltr14) McCullough PA, Collins AJ, Vassalotti JA. Rapid Response: Optimal Definition of Chronic
Kidney Disease as a Cardiovascular Risk State. Southern Medical Journal, Volume 101, 977
Number 10, October 2008
ltr15) Neyou A, McCullough PA. Response to letter to the editor. Am J Emerg Med. 2010 Dec 1.
[Epub ahead of print] No abstract available. PMID: 21129890
ltr16) Palazzuoli A, Ronco C, McCullough PA. Letter by Palazzuoli et al regarding article, "is
worsening renal function an ominous prognostic sign in patients with acute heart failure? The
role of congestion and its interaction with renal function". Circ Heart Fail. 2012 Jul 1;5(4):e79.
PubMed PMID: 22811554
ltr17) O'Keefe JH, Patil HR, Magalski A, Lavie CJ, Vogel RA, McCullough PA. In reply. Mayo Clin
Proc. 2012 Nov;87(11):1133-4. doi: 10.1016/j.mayocp.2012.08.010. PubMed PMID: 23127740
ltr18) McCullough PA. Reply: Vitamin E May Protect Against Contrast-Induced Acute Kidney Injury.
J Am Coll Cardiol. 2017 Apr 11;69(14):1878-1879. doi: 10.1016/j.jacc.2017.01.053. PubMed
PMID: 28385321
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ltr19) Rangaswami J, McCullough PA. Efficacy of Subcutaneous Versus Intravenous Administration
of Furosemide in Patients With Worsening Heart Failure: The Devil Is in the Details. JACC Heart
Fail. 2018 Mar;6(3):266-267. doi: 10.1016/j.jchf.2018.01.010. PubMed PMID: 29496028
ltr20) Rangaswami J, McCullough PA. Clinical Context of Dyskalemias Across the Heart Failure
Spectrum and Their Associated Adverse Outcomes. JACC Heart Fail. 2019 Jun;7(6):533. doi:
10.1016/j.jchf.2019.01.005. PubMed PMID: 31146878.
ltr21) McCullough PA. The Reply. Am J Med. 2021 Mar;134(3):e222-e223. doi:
10.1016/j.amjmed.2020.10.036. PMID: 33637181; PMCID: PMC7901366.
ltr22) McCullough PA. The Reply. Am J Med. 2021 Apr;134(4):e298. doi:
10.1016/j.amjmed.2020.11.028. PMID: 33888224; PMCID: PMC8054639.
ltr23) McCullough PA. Regarding: "Hydroxychloroquine: a comprehensive review and its
controversial role in coronavirus disease 2019". Ann Med. 2021 Dec;53(1):286. doi:
10.1080/07853890.2021.1872094. PMID: 33439042; PMCID: PMC7877973.
ltr24) McCullough PA. The Reply. Am J Med. 2021 May;134(5):e343-e344. doi:
10.1016/j.amjmed.2021.01.011. PMID: 33962708; PMCID: PMC8095713.
ltr25) McCullough PA. The Reply. Am J Med. 2021 May;134(5):e346-e347. doi:
10.1016/j.amjmed.2021.01.013. PMID: 33962710; PMCID: PMC8095728.
ltr26) McCullough PA. The Reply. Am J Med. 2021 Jul;134(7):e440-e441. doi:
10.1016/j.amjmed.2021.02.024. PMID: 34183150; PMCID: PMC8229557.
Textbook Chapters
T1) McCullough PA, Goldstein JG. Chapter 5: Heart Pressures and Catheterization. Cardiac
Catheterization: Concepts, Techniques, and Applications. Uretsky BF, Editor, Blackwell
Science, Inc., Boston, 1997. ISBN 9780865424067
T2) McCullough PA. Section III, Chapter 7: Epidemiology of Coronary Heart Disease.
Interventional Cardiovascular Medicine: Principles and Practice, Second Edition. Roubin GS,
O’Neill WW, Stack RS, Editors, Churchill Livingstone Inc., Philadelphia and New York, 2002,
III, 7, 138-159. ISBN 9780443079795
T3) Franklin BA, McCullough PA, Timmis GC. Chapter: Exercise. Randomized Trials in
Cardiovascular Disease: a Companion Volume to Eugene Braunwald’s “Heart Disease.”
Hennekins CH, Buring JE, Ridker PM, Manson JE, Editors, W. B. Saunders Inc., New York,
1998.
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T4) McCullough PA. Chapter 4. General Examination and Examination Skills, p 41-57 Clinical
Exercise Physiology. Ehrman JK, Gordon PM, Visich PS, Keteyian SJ, Editors, Human Kinetics
Publishers, Inc., 2003. ISBN 9780736002523
T5) Malineni K, McCullough PA. Chapter: Sudden Cardiac Death, eMedicine.com, Textbook of
Medicine, Obstetrics and Gynecology, Psychiatry, and Surgery, 2001.
T6) McCullough PA. Chapter 21: Outcome of Myocardial Infarction in Patients with Renal
Failure, Harrison’s Advances in Cardiology, Eugene Braunwald, M.D., Editor, 2003. pp 123-
128. McGraw-Hill, New York, NY. ISBN 9780071370882
T7) McCullough PA. Chapter 26. Renal Injury Following Contrast Agents, Peripheral Vascular
Disease: Basic Diagnosis and Therapeutic Approaches, Editor: George S. Abela, MD, 2003, pp
000-000. Lippincott Williams & Wilkins, Philadelphia, PA. ISBN 9780781743839
T8) McCullough PA. The effect of renal disease on outcomes of vascular surgery. Fast Facts in
Vascular Surgery, Health Press, Alun H. Davies, MA, DM, FRCS, Editor, 2003-2004;74-86.
ISBN 9781903734513
T9) McCullough PA. Interface between renal disease and cardiovascular illness. Braunwald’s
Heart Disease, 7th Edition, 2004, Zipes DP, Libby P, Bonow RO, Braunwald E, Editors, WB
Saunders, Inc. ISBN 9780721604794
T10)
McCullough PA. Interface between renal disease and cardiovascular illness.
Braunwald’s Heart Disease, 8th Edition, 2006, Zipes DP, Libby P, Bonow RO, Braunwald E,
Editors, WB Saunders, Inc. ISBN 9781416041030
T11)
McCullough PA. Chapter 23. Renal Complications of Contrast Media: Contrast-
Induced Nephropathy, p 239-249. Interventional Cardiology, 1st Edition, 2007. King S,
Yeung A, Editors. The McGraw-Hill Medical, New York. ISBN 9780071415279
T12)
McCullough PA. Chapter 14. Natriuretic peptides in patients with renal failure, p
170-180. Markers in Cardiology: A Case Oriented Approach, 2007. Adams JE, Jaffe AS,
Apple F, Editors. Blackwell Futura, 2007. ISBN 9781405134187
T13)
Miller WM, McCullough PA. Chapter 21. Obesity, p209-218. Pollock’s Textbook of
Cardiovascular Disease and Rehabilitation. Durstine JL, Moore GE, LaMonte MJ, Franklin
BA, Editors. Human Kinetics, 2008. ISBN 0000736059679
T14)
Franklin BA, Miller WM, McCullough PA. Chapter 11: The Metabolic Syndrome.
American Council on Exercise Advanced Health and Fitness Specialist Manual. Edited by
Bryant CX, Green DJ. San Diego, CA. American Council on Exercise; 2008:239-254. ISBN
9781890720278
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T15)
Marso SP, McCullough PA. Chapter 8: Patient-Specific Approaches and
Considerations: Unique Subgroups—Diabetes, Renal Failure, Advanced Age. American
College of Cardiology Cardiac Catheterization and Interventional Self-Assessment Program 3
(CathSAP-3), David J. Moliterno, Editor. ACC, 2008.
http://www.cardiosource.com/GenSAPX/
T16)
Franklin BA, Miller WM, Nori K, McCullough PA. Chapter 12: Guidelines for Exercise
Testing in Diabetics Starting an Exercise Program. Contemporary Diabetes: Diabetes and
Exercise. Edited by Regensteiner JC, Reusch JEB, Stewart K, Veves A. Totowa, NJ: Humana
Press; 2009:263-277. ISBN 9781588299260
T17)
Nguyen, T, Yee T, Mai T, Phan T, McCullough PA. Chapter 6: Diet. Evidence Based
Cardiology Practice: A 21st Century Approach. Edited by Hu D, Nguyen T, Kim MH, Kwan T,
Grines CL, Saito S. Peoples Medical Publishing House—USA, Shelton, CT; 2010; 145-161.
ISBN 9781607950950
T18)
Kodenchery M, Bhat S, El-Ghoroury M, Yamasaki H, McCullough PA. "Coronary
Angiography Before and After Renal Transplantation" Coronary Angiography - The Need for
Improvement in Medical and Interventional Therapy, edited by Branislav Baškot. InTech -
Open Access Publisher, Rijeka, Croatia, Website: http://www.intechweb.org/, permanent
web address: http://www.intechopen.com/articles/show/title/coronary-angiography-
before-and-after-renal-transplantation. ISBN 9789533076416
T19)
Marinescu V, McCullough PA. Chapter 5d. Managing Comorbidities. Chronic Kidney
Disease. Hypertension. Bakris G and Baliga RR Editors, Oxford American Cardiology Library,
Oxford University Press, New York, NY 2012; 71-81. ISBN 9780199754908
T20)
McCullough PA. Chapter 43. Contrast-Induced Acute Kidney Injury. Specialty Board
Review: Cardiology. Baliga RR Editor. The McGraw-Hill Companies, Inc., China, 2012; 467-
473. ISBN 9780071614085
T21)
Zalesin KC, Franklin BA, Miller WM, Peterson ED, McCullough PA. Impact of obesity
on cardiovascular disease. Medical Clinics of North America: Obesity. LeRoith D and
Karnieli E, Editors. WB Saunders Company, New York, NY, 2011 95(5):919-937. ISBN
9781455723690
T22)
McCullough PA. Chapter: Interface between renal disease and cardiovascular
illness. Braunwald’s Heart Disease, 9th Edition, 2011. Zipes DP, Libby P, Bonow RO,
Braunwald E, Editors, WB Saunders, Inc. ISBN 9781437727081
T23)
Hanson ID, McCullough PA. B-type natriuretic peptide: beyond diagnostic
applications. The Kidney in Heart Failure. Bakris GL Editor. Springer, New York, NY,
2012;67-77. ISBN 9781461436935
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T24)
Brown JE, McCullough PA. Chapter 5: Contrast Nephropathy and Kidney Injury.
Textbook of Cardiovascular Intervention, Thompson, CA (Editor), Springer, 2014 (5) 53-63.
ISBN 9781447145288
T25)
Franklin BA, Miller WM, McCullough PA. Chapter 12, The Metabolic Syndrome,
American Medical Council, Medical Exercise Specialist Manual, Skinner JS, Bryant CX, Merrill
S, Green DJ. American Council on Exercise 2015, San Diego CA. ISBN 9781890720520
T26)
Stewart D, Shah G, Brown JR, McCullough, PA. Chapter 240 Contrast-induced acute
kidney injury, Oxford Textbook of Clinical Nephrology, 4th Edition, Managing Editors Turner
Goldsmith DJ, Winearls C, Lamierre N, Himmelfarb J, Remuzzi G, Editors, 2015, Oxford
University Press, United Kingdom. ISBN 9780199592548
T27)
Goldsmith DJ, Kumar N, Henderson H, Cameron BD, McCullough PA. Chapter 106
Malnutrition, obesity, and undernutrition in chronic kidney disease, Oxford Textbook of
Clinical Nephrology, 4th Edition, Managing Editors Turner Goldsmith DJ, Winearls C,
Lamierre N, Himmelfarb J, Remuzzi G, Editors, 2015, Oxford University Press, United
Kingdom. ISBN 9780199592548
T28)
McCullough PA. Chapter 18 Future Therapeutic Prospects for Treatment of
Cardiorenal Syndromes, p 189-195, Cardiorenal Challenges. Goldsmith DA, Covic A, Spaak
J. Editors, Springer International Publishing AG, Cham, 2015, Zug, Switzerland. ISBN
9783319091624
T29)
McCullough PA. Chapter 88: Interface between renal disease and cardiovascular
illness. Braunwald’s Heart Disease, 10th Edition, 2015, pp 1909-1930. Zipes DP, Libby P,
Bonow RO, Braunwald E, Editors, WB Saunders, Inc. ISBN 9781455751334
T30)
McCullough PA. Chapter 24: Cardiovascular Disease in Chronic Kidney Disease.
Essentials of Chronic Kidney Disease, 2015, pp 239-245. Fadem SZ, Editor, Nova Publishers,
ISBN-13: 978-1634825429
T31)
Prasad A, McCullough PA. Chapter 19: Renal Complications of Contrast Media.
Interventional Cardiology, 2nd Edition, 2018, pp 293-306. Samady H, Fearon WF, Yeung AC,
King SB, Editors, McGraw-Hill, ISBN-13: 978-0071820363
T32)
Rangaswami J, Lerma EV, McCullough PA, Editors. Kidney Disease in the Cardiac
Catheterization Laboratory, 1st Edition 2020, ISBN-13: 978-3030454135 ISBN-10:
3030454134, Springer Nature Switzerland AG. Chapter 27 Ronco C, Ronco F, McCullough
PA. A Call to Action to Develop Integrated Curricula in Cardiorenal Medicine, pp 449-463.
T33)
McCullough PA, Ronco C. Textbook of Cardiorenal Medicine, 1st Edition 2021, ISBN-
13: 978-3030574598 ISBN-10: 3030574598, Springer Nature Switzerland AG. Chapter 1
McCullough PA, Kluger AY. Implications of Chronic Kidney Disease on the Epidemiology of
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Cardiovascular Disease, pp 1-6. Chapter 8 Rocha N, McCullough PA. Type 2 Cardiorenal
Syndrome, pp 75-94. Chapter 17 McCullough PA Novel Biomarkers of Chronic Cardiorenal
Disease, pp 227-234.
.
Invited Non-Peer Reviewed Works
1) McCullough PA. Acute Renal Failure after Coronary Intervention. American College of
Cardiology Educational Highlights, Fall 1997 Issue, C.R. Conti, Editor
2) McCullough PA, Thompson RJ, Tobin KJ, Kahn JK, Schwender F, O’Neill WW. Outcome of
Out-of-Hospital Cardiac Arrest Survivors. Cardiology Review, 2000;17:15-19
3) Thompson RJ, McCullough PA, Kahn JK, O’Neill WW. A Simple Scoring System to Predict
Clinical Outcome after Resuscitation from Cardiac Arrest. The Journal of Critical Illness,
1998;13:298-300
4) McCullough PA. Clinical Evaluation. Part I. The Cardiopulmonary System. Clinical Exercise
Physiology, 1999;1:33-41
5) McCullough PA. Clinical Evaluation. Part II. The Musculoskeletal and other Body Systems.
Clinical Exercise Physiology, 1999:1:92-99
6) McCullough PA. Ridogrel: Literature Evaluation. IDdb Reports, Current Drugs Ltd,
February, 1999
7) McCullough PA. Debate Commentary: Complete Assessment of the Lipid Profile is Advised.
Medical Crossfire, 1999:5;52
8) McCullough PA. Narrative Fields in Hospital Records. Invited comment on Loss of Narrative
Data in New Zealand Health Statistics Public Hospital Injury Files, John Langley (Australasian
Epidemiologist 1998:5.4). The Australasian Epidemiologist, 1999;6.1:17-18
9) McCullough PA. Previews in Cardiovascular Medicine: Prediction and Prevention of
Contrast Nephropathy. Rev Cardiovasc Med. 2001;2(Suppl 1):S1-S3
10) Creager MA, Faxon DP, Fonarow GC, Gross SB, Hachamovitch R, Jacobs AK, Lepor NE,
McCullough PA, Naqvi T, Nesto RW, Prystowsky EN, Shah PK, Vogel RA, Yeung AC. Meeting
Reviews: Best of the AHA Scientific Sessions, 2001. Rev Cardiovasc Med. 2002;3(1):22-48
11) McCullough PA. Update from the International Society on Hypertension in Blacks.
Rev Cardiovasc Med. 2002 Fall;3(4):192-95. PMID: 12650156
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12) Nguyen PN, Spertus JA, McCullough PA. Is there a Heart Failure Epidemic? Cardiology
Review 2002;19(9):32-36
13) Lepor NE, Yeung AC, McCullough PA, Creager MA, Weber MA, Jacobs AK, Faxon DP, Vogel
RA, Gersh BJ. Meeting Review: Best of the ACC Scientific Session 2002. Rev Cardiovasc
Med 2002;3(2):85-104
14) Franklin BA, deJong A, McCullough PA. Interpreting Exercise Test-Fitness Data for Your
Patients. Am J Sports 2003;5:12-17
15) McCullough PA. The interface between heart disease and renal dysfunction: from
association to action. ACC Current Journal Review 2003;12(2):20-24
16) Fonarow GC, Prystowsky EN, McCullough PA, Lepor NE, Watson KE, Gersh BJ, Young JJ,
Kereiakes D, Faxon DP, Weyman A, Jacobs AK, Yeung A, Holmes D, Berger P, Weber MA.
Meeting Review: Best of the ACC Scientific Sessions 2003. Rev Cardiovasc Med.
2003;4(3):150-179
17) McCullough PA. Debate Commentary: Atrial Fibrillation: Preventing Thromboembolism
and Ischemic Stroke. Medical Crossfire 2003, 4(10), 3-17
18) Creager M, Faxon DP, Gersh BJ, Jacobs AK, Lepor NE, McCullough PA, Naqvi T, Prystowsky
EN, Shah PK, Watson KE, Weber MA, Wyman A. Meeting Review: Best of the AHA Scientific
Sessions 2003. Rev Cardiovasc Med 2004;5(1)26-52
19) McCullough PA. The use of contrast media in peripheral, combined, and sequential
procedures. Applications in Imaging: Cardiac Interventions: Contrast Use in Renally
Compromised Patients 2003;Sept:47-51
20) McCullough PA. Chapter Four: Major Risk Factors for Chronic Kidney Disease. Kidney Early
Evaluation Program Annual Data Report. Am J Kid Dis 2003;42(5):S34-S41
21) Fonarow GC, Prystowsky EN, Lepor NE, Weyman AE, Weber MA, Watson KE, Young JJ,
Kereiakes DJ, McCullough PA, Gersh BJ. Best of the ACC Scientific Session 2004. Rev
Cardiovasc Med. 2004;5(2)104-129
22) Franklin BA, de Jong A, Kahn JK, McCullough PA. Fitness and mortality in the primary and
secondary prevention of coronary artery disease: Does the effort justify the outcome? Am J
Med Sports 2004;6:23-27
23) McCullough PA, Franklin BA. Atherosclerosis: Conventional risk factors and cardiac
events—debunking an old myth about prevalence. Rev Cardiovasc Med. 2004;5(3):185-186
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24) Dutcher JR, McCullough PA. Commentary: Glycoprotein IIb/IIIa Inhibitors in Acute
Coronary Syndromes. Evidenced Based Cardiovascular Medicine 2004;8:362-363
25) McCullough PA, Faxon DP, Fonarow GC, Jacobs AK, Watson KE, Weyman AC. Meeting
Review: Best of the AHA 2004. Rev Cardiovasc Med. 2005;6(1):33-46
26) Bashore TM, Faxon DP, Fonarow GC, Jacobs AK, Lepor NE, McCullough PA, Shah PK, Weber
MA, Yeung AC. Best of the ACC Scientific Session 2005. Rev Cardiovasc Med. 2005
Spring;6(2):98-117
27) Fonarow GC, Lepor NE, McCullough PA, Jacobs AK, Bashore, TM, Faxon DP. Best of the AHA
Scientific Session 2005. Rev Cardiovasc Med. 2006 Winter;7(1):23-36
28) McCullough PA. Clinical utility of blood natriuretic peptide levels. Business Briefing: US
Cardiology 2006. Touch Briefings, Touch Cardiology. www.touchcardiology.com
29) McCullough PA, Wase A. Do implantable cardioverter-defibrillators improve survival in
dialysis patients after cardiac arrest? Nature Clinical Practice Nephrology 2006; 2(2): 70-71
30) McCullough PA. Ranolazine: focusing on angina pectoris. Drugs of Today 2006, 42 (3):177-
183
31) Singh PP, Nesto RW, Faxon DP, Lepor NE, Watson KE, Jacobs AK, McCullough PA. Best of
the AHA Scientific Sessions 2006. Rev Cardiovasc Med. 2007 Winter;8(1):25-35. PMID:
17401300
32) McCullough PA. Safety Concerns Trump Public Health Benefit in the Eyes of the FDA
Cardiorenal Panel. FDA Advisory Committee Did Not Recommend Approval Of Rimonabant
(ZIMULTI(R)) For Use In Obese And Overweight Patients With Associated Risks Factors.
www.medicalnewstoday.com GLG NewsWatch for 6/14/2007
33) Friedewald VE, Goldfarb S, Laskey WK, McCullough PA, Roberts WC. The Editor's
Roundtable: Contrast-Induced Nephropathy. Am J Cardiol. 2007 Aug 1;100(3):544-51. Epub
2007 Jun 4. PMID: 17659944
34) McCullough PA, Lepor NE. Erratum - the rosiglitazone meta-analysis. Rev Cardiovasc Med.
2007 Summer;8(3):174. PMID: 17938618
35) McCullough PA, Chronic Kidney Disease as a Cardiovascular Risk State and Considerations
for the Use of Statins. The Fats of Life, Lipoproteins and Vascular Disease Division, American
Association of Clinical Chemistry, Volume XXII, No 1, 9-16 Winter 2008
36) Lepor NE, McCullough PA, Jacobs AK. Best of the AHA Scientific Sessions 2007. Rev
Cardiovasc Med. 2008 Winter;9(1):62-9. PMID: 18418310
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37) Lepor NE, McCullough PA. Best of the ACC 2010 Scientific Session. Rev Cardiovasc Med.
2010 Summer;11(3):e153-63
38) Narala KR, LaLonde TA, Hassan S, McCullough PA. Management of Chronic Coronary
Disease and Acute Coronary Syndromes in Patients with Chronic Kidney Disease. US
Cardiology, 2011;8(2):123-31
39) Larsen T, Narala KR, McCullough PA. Type 4 Cardiorenal Syndrome: Myocardial
Dysfunction, Fibrosis, and Heart Failure in Patients with Chronic Kidney Disease. J Clinic
Experiment Cardiol 2012, 3:4. http://dx.doi.org/10.4172/2155-9880.1000186
INVITED LECTURES: NATIONAL AND INTERNATIONAL FORUMS
L1) “The Role of Triage Angiography in Acute Coronary Syndromes.” Advances in Interventional
Cardiology. WBH and the University of Maryland, Aruba, April, 1997.
L2) “New Understandings of Anticoagulation During Unstable Angina.” Co-Chair, American
College of Cardiology 47th Annual Scientific Session, Atlanta, Georgia, March 30, 1998.
L3) National Library of Medicine: The Emerging Health Information Infrastructure '99.
"Electronic Outcomes", Washington, D.C., April 28, 1999.
L4) Kansas City Southwest Clinical Society, 77th Annual Clinical Conference, Overland Park,
Kansas: “Cardiac-Renal Risk: Incorporating Scientific Evidence into Your Practice,” October
29, 1999.
L5) The Health Forum, Best Practices, Chicago, Illinois. “Overview of Cardiovascular Health
Fellowship,” December 9, 1999.
L6) AHA Scientific Conference on Existing Databases: Do They Hold Answers to Clinical
Questions in Geriatric Cardiovascular Disease and Stroke? “Resource Utilization Among
Congestive Heart Failure (R.E.A.C.H.) Database Overview,” Washington, DC, January 27,
2000.
L7) Health Forum Cardiovascular Health Fellowship Retreat: “Cardiovascular Risk and Health,”
Colorado Springs, CO, July 20, 2000.
L8) Third Annual Center for Health Futures Advisory Board Meeting: “Congestive Heart
Failure,” La Jolla, CA, August 24, 2000.
L9) Health Forum ACT Learning Collaborative Meeting: “Bridging Clinical, Community, and
Population Health Strategies,” St. Joseph, MO, September 20, 2000.
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L10)
“Renal Disease as an Independent Risk Factor for Cardiovascular Disease in
Diabetes,” The Nexus of Cardiovascular and Renal Disease, Duke Clinical Research Institute,
Tyson’s Corner, VA, November 4, 2000.
L11)
“Atherosclerosis and Heart Disease,” Winter Scientific Seminar, Missouri Society of
the American College of Osteopathic Physicians, Kansas City, MO, January 27, 2001.
L12)
“Routine vs Selective Intervention in Acute Coronary Syndromes,” Tenth Annual
Cardiovascular Conference at Beaver Creek, Colorado, WBH and Duke University, February
14, 2001.
L13)
“Intervention in the Patient with Renal Insufficiency,” Tenth Annual Cardiovascular
Conference at Beaver Creek, Colorado, WBH and Duke University, February 16, 2001.
L14)
“The Epidemic of Cardiovascular Disease and Cardiorenal Risk,” The Nexus of
Cardiovascular and Renal Disease, Duke Clinical Research Institute, Tyson’s Corner, VA,
February 24, 2001.
L15)
“Cardiovascular Risk in Chronic Kidney Disease: Cardiorenal Risk,” Symposium on
Cardio-renal Consequences of Angiotensin II, Insights from AII Blockade, NKF Spring Clinical
Meeting, Orlando, FL, April 18, 2001.
L16)
Plenary Session: “Cardiac Emergencies and Cardiac Critical Care,” American College
of Chest Physicians, CHEST 2001, Philadelphia, PA, November 5, 2001.
L17)
“Cardiorenal Risk,” The 33rd Annual ACC Cardiovascular Conference at Snowmass,
Snowmass, Colorado, January 18, 2002.
L18)
“Epidemiology of Diabetes and Its Cardiovascular Risk” Eleventh Annual
Cardiovascular Conference at Beaver Creek, Colorado, WBH and Duke University, February
14, 2002.
L19)
“Late-Breaking Clinical Trials II: A Prospective, Blinded Trial of B-Type Natriuretic
Peptide as a Diagnostic Test for the Emergency Diagnosis of Heart Failure: The Breathing
Not Properly (BNP) Multinational Study,” March 19, 2002, 51st Annual Scientific Session of
the American College of Cardiology, Atlanta, GA.
L20)
“Scope of Cardiovascular Complications in Patients with Kidney Disease.” Plenary
Session III: Reversing Cardiovascular Complications in Patients with Kidney Disease.
International Society on Hypertension in Blacks: 17th International Interdisciplinary
Conference on Hypertension and Related Risk Factors in Ethnic Populations, Miami, FL, June
11, 2002.
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L21)
“Epidemiology: Renal—Chronic Kidney Disease.” Atherosclerotic Vascular Disease
Conference, AHA, Boston, MA, July 8, 2002.
L22)
“B-type Natriuretic Peptide Should be a Part of the Diagnostic Evaluation of Heart
Failure: Implications from the Breathing Not Properly (BNP) Multinational Study”
International Academy of Cardiology 8th World Congress on Heart Failure—Mechanisms and
Management, Washington, DC, July 15, 2002.
L23)
“Epidemiology and Physiology of Radiocontrast Nephropathy and its Impact on
Outcomes” Prevent the Event Transcatheter Therapeutics 2002 Satellite Symposium,
Washington, DC, September 26, 2002.
L24)
“Calcification or ‘Phosphication’—Controversies of Calcium Phosphate Deposition:
Invited Lecture: Coronary Calcification: A Predictor of Future Events or a Marker of Plaque
Stability? American Society of Nephrology 2002 Annual Scientific Sessions Satellite
Symposium, Philadelphia, PA, November 1, 2002.
L25)
“Renal Insufficiency and Clinical Outcome” Cardiovascular Seminar, AHA Scientific
Sessions, Chicago, IL, November 18, 2002.
L26)
“Role of BNP in the Diagnosis of Heart Failure” ACC 34th Annual Cardiovascular
Conference at Snowmass, CO, January 14, 2003.
L27)
“Managing the Patient with Combined Heart and Renal Failure—the Importance of
Anemia” ACC 34th Annual Cardiovascular Conference at Snowmass, CO, January 14, 2003.
L28)
“The Emerging Healthcare Crisis of Obesity,” Twelfth Annual Cardiovascular
Conference at Beaver Creek, CO, February 10, 2003.
L29)
“BNP in the Management of Heart Failure,” Twelfth Annual Cardiovascular
Conference at Beaver Creek, CO, February 11, 2003.
L30)
“Contrast Nephropathy: Can it be Eliminated,” Twelfth Annual Cardiovascular
Conference at Beaver Creek, CO, February 13, 2003.
L31)
“How Subtle Degrees of Renal Dysfunction Work as a Cardiac Risk Factor” First
Cardiovascular Prevention Symposium: Updates and New Guidelines. AHA, Puerto Rico
Chapter, San Juan, PR, March 22, 2003.
L32)
“What Is the Incremental Diagnostic Value of B-Type Natriuretic Peptide in Heart
Failure?” Symposium. American College of Cardiology Scientific Sessions, 2003, Chicago, IL,
April 1, 2003.
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L33)
“Heart Failure Insights From Ejection Fraction” Session Co-Chair. Oral Contributions.
American College of Cardiology Scientific Sessions, 2003, Chicago, IL, April 1, 2003.
L34)
“Chronic Renal Insufficiency as a Vascular Risk Factor” 14th Annual Scientific Sessions
of the Society for Vascular Biology and Medicine, Chicago, IL, June 7, 2003.
L35)
“Phosphate Control and Calcification from a Cardiologist’s Perspective” World
Congress of Nephrology Satellite Symposium, Berlin, Germany, June 12, 2003.
L36)
“Renal Disease is a Risk Factor for Cardiovascular Disease” ACC 29th Annual Tutorials
in the Tetons 2003: Update in Cardiovascular Disease, August 25-27. 2003.
L37)
“Diagnosis of Congestive Heart Failure: Is BNP Needed in Every Case?” ACC 29th
Annual Tutorials in the Tetons 2003: Update in Cardiovascular Disease, August 25-27. 2003.
L38)
“How to Treat Combined Heart and Renal Failure with Hypertension” ACC 29th
Annual Tutorials in the Tetons 2003: Update in Cardiovascular Disease, August 25-27. 2003.
L39)
“Which Agents Prevent Contrast-Induced Nephropathy?” European Society of
Cardiology 2003 Symposium: Managing Patients at Risk for Contrast-Induced Nephropathy,
Vienna, Austria, September 2, 2003.
L40)
“Epidemiology of Contrast Nephropathy” Symposium Chair for “A Contrast in Risk:
Radiographic Imaging in the Renally Compromised Patient”, Satellite Symposium at the
Transcatheter and Therapeutics Scientific Meeting, Washington, DC, September 17, 2003.
L41)
“Update on Cardiovascular Risk Reduction in Acute Coronary Syndrome Patients”
14th Annual Great Wall International Congress of Cardiology, Beijing, China, October 10-13,
2003.
L42)
“Renal Function and Dysfunction in Coronary Arteriography” 14th Annual Great Wall
International Congress of Cardiology, Beijing, China, October 10-13, 2003.
L43)
“Interventional Cardiology 2003: Bench to Bedside and Beyond, Session III: Contrast
Nephropathy: Separating the Hype from the Data. Antagonist: Contrast Nephropathy Can
be Prevented.” AHA Scientific Sessions 2003, November 9, 2003, Orlando, FL.
L44)
”Reversing Diabetes and Its Consequences: Pipe Dream or Reality?” The 35th Annual
Cardiovascular Conference at Snowmass, ACC, Snowmass, CO, January 12-16, 2004.
L45)
“Refining the Use of B-type Natriuretic Peptide as a Diagnostic Test in Clinical
Practice” The 35th Annual Cardiovascular Conference at Snowmass, ACC, Snowmass, CO,
January 12-16, 2004.
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L46)
“Practical Management of Obesity for the Cardiologist: The Future of Dietary
Management and Bariatric Surgery” The 35th Annual Cardiovascular Conference at
Snowmass, ACC, Snowmass, CO, January 12-16, 2004.
L47)
“Update from the Hypertension World: JNC 7—What’s New and How Will it
Influence Practice?” Thirteenth Annual Cardiovascular Conference at Beaver Creek,
Colorado, WBH and Duke University, February 9-13, 2003
L48)
“The Lethal Couplet” Thirteenth Annual Cardiovascular Conference at Beaver Creek,
Colorado, WBH and Duke University, February 9-13, 2003
L49)
“BNP to Differentiate Between Cardiac and Extracardiac Sources of Dyspnea” 33rd
Critical Care Congress, Society of Critical Care Medicine, Orlando, Florida, February 23,
2004.
L50)
“BNP Testing: Is It Ready for In-Hospital Monitoring of Therapy?” Point-of-Care
Symposium, American College of Cardiology Scientific Sessions 2004, New Orleans, LA,
March 8, 2004.
L51)
“Role of Brain Natriuretic Peptide Levels in Diagnosis” Natriuretic Peptides
Symposium, American College of Cardiology Scientific Sessions 2004, New Orleans, LA,
March 8, 2004.
L52)
“Renal Insufficiency and the Heart” Symposium Co-Chair, American College of
Cardiology Scientific Sessions 2004, New Orleans, LA, March 9, 2004.
L53)
“Renal Insufficiency and Bypass Surgery” Renal Insufficiency and the Heart
Symposium, American College of Cardiology Scientific Sessions 2004, New Orleans, LA,
March 9, 2004.
L54)
“Causes and Consequences of Contrast-Induced Nephropathy and other Major
Adverse Coronary Events” Contrast-Induced Nephropathy: Addressing the Needs of the
High Risk Patient. A Satellite Symposium to the American College of Cardiology Scientific
Sessions 2004, New Orleans, LA, March 9, 2004.
L55)
“Chronic Kidney Disease as a Cardiovascular Risk Factor” 2nd Annual Scientific
Symposium, AHA of Puerto Rico, San Juan, PR, March 13, 2004
L56)
“Modern use of Angiotensin Receptor Blockade in Cardiovascular Disease” 2nd
Annual Scientific Symposium, AHA of Puerto Rico, San Juan, PR, March 13, 2004
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L57)
“Chronic Kidney Disease and Cardiovascular Disease” Satellite Symposium: Impact
of Anemia Correction in Cardiovascular Patients, American Society of Hypertension Annual
Scientific Session, New York, NY, May 22, 2004.
L58)
“Contrast-Induced Nephropathy—Clinical Anomaly or Reality” Satellite Symposium:
Selecting Contrast Media - Implications for Patient outcomes, EuroPCR 2004, Paris, France,
May 26, 2004.
L59)
“Contrast Nephropathy” Intervention 2004. American College of Cardiology
Nationwide Symposium, CNN Center, Atlanta, GA, June 2, 2004.
L60)
“Technical Issues in Selection of the BNP Assay” Satellite Symposium of the American
Association of Clinical Chemistry, Los Angeles, CA, July 28, 2004.
L61)
“B-type Natriuretic Peptide in Clinical Practice” New Development in Cardiac
Biomarkers for Detection and Management of Cardiovascular Diseases, EBAC Accredited
Educational Programme, in conjunction with the European Society of Cardiology 2004
Annual Congress, Munich, Germany, August 30, 2004.
L62)
“Hot Topics: Renal Disease and Contrast Nephropathy—Implications for the PCI
Patient” Session Moderator, Transcatheter Cardiovascular Therapeutics 2004, September
27, 2004.
L63)
“Definition and Pathophysiology of Contrast Nephropathy”, “Hot Topics: Renal
Disease and Contrast Nephropathy—Implications for the PCI Patient” Transcatheter
Cardiovascular Therapeutics 2004, September 27, 2004.
L64)
“Use of BNP in Clinical Practice” “Hot Topics: Clinical Utility of Biomarkers”
Transcatheter Cardiovascular Therapeutics 2004, September 28, 2004.
L65)
“Contrast Media, Renal Insufficiency, and Radiocontrast Nephropathy” Introduction
to Cardiac Catheterization and Indications for Percutaneous Interventions, 7th Annual
Interventional Cardiology Self Assessment and Review Course, Transcatheter Cardiovascular
Therapeutics 2004, September 29, 2004.
L66)
“Body Weight—Optimal Targets and How Good are We in Getting There” “Drug
Combinations for Cardiovascular Disease” Duke Clinical Research Institute and U.S. Food
and Drug Administration Think Tank, Washington, DC, October 8, 2004.
L67)
“Does Coronary Calcification Imply Plaque Instability?” Managing Cardiovascular and
Calcium/Phosphorus Complications of CKD. Official Luncheon Symposium, Renal Week
2004, American Society of Nephrology, St. Louis, MO, October 20, 2004.
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L68)
“B-type Natriuretic Peptide in the Diagnosis of Acute Heart Failure,” New Advances in
the Diagnosis and Management of Acute Decompensated Heart Failure, Satellite
Symposium to the AHA Scientific Sessions 2004, New Orleans, LA, November 8, 2004.
L69)
“Oportunidades para Aprimoramento no Tratamiento da Insuficiencia Cardiaca,” 3rd
Congresso Brasileiro de Insuficiencia Cardiaca, II Simposio Luso-Brasileiro de Insufiencia
Cardiaca, I Encontró Multiporfissional em Insuficiencia Cardiaca, II Simposio
Latinoamericano de Insuficiencia Cardiaca, (Portugese) Salvador, Bahía, Brasil, November
25-27, 2004.
L70)
“Peptideo Natriuretico Intravenoso-Perspectivas para Emprego na IC
Descompensada,” 3rd Congresso Brasileiro de Insuficiencia Cardiaca, II Simposio Luso-
Brasileiro de Insufiencia Cardiaca, I Encontro Multiprofissional em Insuficiencia Cardiaca, II
Simposio Latinoamericano de Insuficiencia Cardiaca, (Portugese) Salvador, Bahia, Brasil,
November 25-27, 2004.
L71)
“Nesiritide (Peptideo Natriuretico Intravenoso) uma Nova Arma no Tratamento da IC
Grave e Decompensada,” 3rd Congresso Brasileiro de Insuficiencia Cardiaca, II Simposio
Luso-Brasileiro de Insufiencia Cardiaca, I Encontro Multiporfissional em Insuficiencia
Cardiaca, II Simposio Latinoamericano de Insuficiencia Cardiaca, (Portuguese) Salvador,
Bahia, Brasil, November 25-27, 2004.
L72)
“Conferenca Magna (Keynote Address): The Cardiorenal Intersection: Crossroads to
the Future,” 3rd Congresso Brasileiro de Insuficiencia Cardiaca, II Simposio Luso-Brasileiro
de Insufiencia Cardiaca, I Encontro Multiporfissional em Insuficiencia Cardiaca, II Simposio
Latinoamericano de Insuficiencia Cardiaca, (Portuguese) Salvador, Bahia, Brasil, November
25-27, 2004.
L73)
“Practical Use of BNP in the Diagnosis and Management of Heart Failure” Medical
Grand Rounds, Olathe Regional Medical Center, Olathe, KS, December 3, 2004.
L74)
“Management of Heart and Renal Failure” The 36th Annual Cardiovascular
Conference at Snowmass, ACC, Snowmass, CO, January 18, 2005.
L75)
“Contrast-Induced Nephropathy” The 36th Annual Cardiovascular Conference at
Snowmass, ACC, Snowmass, CO, January 18, 2005.
L76)
“Combined Heart and Kidney Failure” Cardiovascular Conference at Snowmass,
Aspen, CO, January 18, 2005.
L77)
“Practice Strategies and Protocols to Reduce Renal Complications” PCI:
Understanding and Managing In-Hospital Cardiac and Renal Complications, 3rd European
Summit, Chantily, France, February 11, 2005.
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L78)
“HDL Cholesterol: A Powerful New Therapeutic Target” 14th (Conference Chair)
Annual Cardiovascular Conference at Beaver Creek, Beaver Creek, CO, February 14, 2005.
L79)
“BNP-ology, is the Enthusiasm Warranted?” (Conference Chair) 14th Annual
Cardiovascular Conference at Beaver Creek, Beaver Creek, CO, February 15, 2005.
L80)
“Anticoagulation for Atrial Fibrillation: Can Warfarin be Replaced?” (Conference
Chair) 14th Annual Cardiovascular Conference at Beaver Creek, Beaver Creek, CO, February
18, 2005.
L81)
"New Multimarker Strategies in the Diagnosis of Acute Coronary Syndromes" Satellite
Symposium to the 54th Annual American College of Cardiology Scientific Sessions 2005,
Orlando, FL, March 7, 2005.
L82)
“Effect of Lowering LDL Level on Progression of Vascular Calcification” Reducing the
Burden of Cardiovascular Calcification in Chronic Kidney Disease, Satellite Symposium to the
Renal Physicians Association Annual Meeting, Washington, DC, March 20, 2005.
L83)
"Why Chronic Kidney disease is a CVD risk factor: Practical Implications in the Care of
Cardiovascular Patients" Cardiology Grand Rounds, Clinical Science Institute, Galway,
Ireland, UK, May 5, 2005.
L84)
“Clinical Application of B-type Natriuretic Peptide Levels in the Care of Cardiovascular
Patients” EuroLab 2005, Glasgow, Scotland, UK, May 9, 2005.
L85)
“Anemia Is a Cardiovascular Risk Factor in Patients With Diabetic Nephropathy” The
Kidney is a Key Link between Diabetes and Cardiovascular Disease: Managing Risk; Satellite
Symposia to the Annual Scientific Sessions of the American Association of Clinical
Endocrinology, Washington, DC, May 18, 2005.
L86)
“CIN: Emerging Trends in Identifying and Managing the At-risk Patient”
Cardiovascular and Interventional Radiology Society of Europe (CIRSE) 2005, Nice, France,
September 13, 2005.
L87)
“Recent Advances in Cardiac Markers and their Clinical Role in Cardiovascular
Disease: Update of the BNP Consensus Panel Statements and Cost Effectiveness of BNP
Testing” Turning Science into Caring Programme, Abbott European Laboratory Symposium,
Wiesbaden-Delkenheim, Germany, October 14, 2005.
L88)
“Epidemiology and Prevention of Contrast Nephropathy” Transcatheter Therapeutics
Annual Scientific Sessions, Washington, DC, October 19, 2005.
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L89)
“BNP—What Does it All Mean?” Heart Failure 2005: What to Do for the Failing Left
Ventricle” AHA Symposium in Conjunction with the 2005 Scientific Sessions, Dallas, TX,
November 11, 2005.
L90)
“How to Use Cardiac Biomarkers in Heart Failure” 2005 Annual Scientific Sessions of
the AHA, Dallas, TX, November 14, 2005, broadcasted nationally as “Best of Sessions 2005
on Wednesday, November 30 from 1:00-2:30PM EST”
L91)
“Chronic Kidney Disease as a Cardiovascular Risk State: Practical Management for
the Cardiologist” St. Vincent’s Hospital, University of British Columbia, Distinguished
Speakers in Cardiovascular Medicine, 2005-2006, Vancouver, BC, Canada, December, 1,
2005.
L92)
“Anemia, Chronic Kidney Disease, and Cardiovascular Disease: Diagnosis, Prognosis,
and Treatment. Nephrology Grand Rounds, University of British Columbia, St. Vincent’s
Hospital, Vancouver, BC, Canada, December 2, 2005.
L93)
“The Deadly Triangle of Anemia, Kidney and Heart Disease: Implications for
Treatment and Management” 37th Annual Cardiovascular Conference at Snowmass,
January 20, 2006, Snowmass, CO.
L94)
“Anemia in Cardiovascular Patients: Diagnosis, Prognosis, and Therapy.” AHA,
Prevention VIII Conference: Kidney Disease, Hypertension, and Cardiovascular Disease,
January 27, 2006, Orlando, FL.
L95)
“Update on Bariatric Surgery” (Conference Chair) 15th Annual Cardiovascular
Conference at Beaver Creek, Beaver Creek, CO, February 17, 2006.
L96)
“Multimarker Approach to Chest Pain.” Satellite Symposium to the Annual Scientific
Sessions of the American College of Cardiology, March 11, 2006, Atlanta, GA.
L97)
” Preventing Contrast Nephropathy: What Works?” American College of Cardiology
Annual Scientific Sessions (ACC.06 and the i2 Summit 2006), March 14, 2006, Atlanta, GA.
L98)
“Consensus statements on strategies to reduce the risk of CIN.” Satellite Symposium
Society for Cardiac Angiography and Intervention 29th Annual Scientific Sessions
(Symposium Chair): Consensus Statements on Contrast-Induced Nephropathy (CIN): Report
of an International, Multidisciplinary Panel, Chicago, IL, May 11, 2006.
L99)
“Contrast-induced nephropathy: identifying and managing the patient at risk.” Euro
PCR 2006 Satellite Symposium: The Underestimated Impact of Contrast Media on Patient
Outcomes in PCI (Symposium Chair), Paris, France, May 27, 2006.
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L100)
“Debate: Acute Decompensated Heart Failure--Biomarker will suffice” 17th Annual
Scientific Sessions of the American Society of Echocardiography, Baltimore, MD, June 6,
2006.
L101)
“Heart and Kidney: Clinical Impact of Contrast Media” Update on Cardiovascular
Disease 2006, Casa Di Cura Montevergine, Napoli Castel Dell’Ovo, Naples, Italy, June 19,
2006.
L102)
“Cardiovascular Disease in CKD: Where Does Calcium Fit In?” Satellite Symposia:
Current Strategies for the Management of Hyperphosphatemia in End-Stage Renal Disease.
European Renal Association/European Dialysis and Transplantation Association Annual
Scientific Meeting, Glasgow, Scotland, July 17, 2006.
L103)
“Applications of BNP in Cardiovascular Disease” Satellite Symposia: New and
Evolving Markers for Cardiovascular Disease: Myeloperoxidase (MPO) and BNP. American
Association of Clinical Chemistry Annual Meeting, Chicago, IL, July 26, 2006.
L104)
“Clinical Applications of B-type Natriuretic Peptide Testing” Clinical Biochemistry
Satellite Symposium: The Role of Biochemical Markers in Clinical Cardiology, Sponsored by
the Australasian Association of Clinical Biochemists at the 54th Annual Scientific Meeting of
the Cardiac Society of Australia and New Zealand, Canberra, Australia, August 4, 2006.
L105)
“Update on BNP in the Management of Heart Failure” 54th Annual Scientific Meeting
of the Cardiac Society of Australia and New Zealand, Canberra, Australia, August 6, 2006.
L106)
“Update on BNP in the Management of Heart Failure” Cardiology Grand Rounds,
Royal North Shore Hospital, Sydney, Australia, August 7, 2006.
L107)
“Contrast-Induced Nephropathy: Identifying and Managing the Patient at Risk”
Advances in Contrast-Enhanced Imaging: Improving Outcomes and Reducing Risks of
Iodinated Contrast (Chairman), a CME Satellite Symposium at the Transcatheter
Therapeutics 2006 Conference, Washington, DC, October 24, 2006.
L108)
“Cardiorenal Syndrome: Etiology, Therapy, and Prognosis” Unresolved Issues in
Heart Failure, Cardiovascular Seminars, 2006 Annual Scientific Sessions of the AHA, Chicago,
IL, November 14, 2006
L109)
“Prevention and Management of CAD in CKD” Coronary Artery Disease in CKD:
Updating the Pathophysiology and Management. Official Symposium of the American
Society of Nephrology, Sand Diego, CA, November 16, 2006.
L110)
“Pharmacologic Prevention of Sudden Death in Dialysis Patients” Sudden Death in
Hemodialysis Patients: Towards Prevention. American Society of Nephrology Renal Week
2007, San Diego, CA, November 17, 2006.
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L111)
“Contrast Nephropathy: Finding Consensus on a Rational Approach” Radiology
Grand Rounds, Hôpital Notre-Dame, University of Montreal, Canada, November 23, 2006.
L112)
“Contrast Nephropathy: Finding Consensus on a Rational Approach” Radiology
Grand Rounds, Hôpital St-Luc, University of Montreal, Canada, November 23, 2006.
L113)
“Cardiorenal Syndrome and Anemia” 3rd Annual Heart Failure University (HFU)
Cardiovascular Fellows Program, Los Angeles, CA, December 2, 2006.
L114)
“Implications of Age-Related Decline in Renal Function” 16th Annual Cardiovascular
Conference at Beaver Creek, Beaver Creek, CO, February 12, 2007.
L115)
“Using BNP in Your Practice: Pearls and Pitfalls” 16th Annual Cardiovascular
Conference at Beaver Creek, Beaver Creek, CO, February 15, 2007.
L116)
“Consensus Panel Findings on Contrast Nephropathy” 16th Annual Cardiovascular
Conference at Beaver Creek, Beaver Creek, CO, February 16, 2007.
L117)
“Measuring BNP in ACS,” American College of Cardiology Scientific Sessions Satellite
Symposium, “ACS & Biomarkers: From Molecules to Patient Management”, New Orleans,
LA, March 24, 2007.
L118)
“Anemia Correction and CVD Trials” “Ask the Experts” clinicaltrialresults.org,
American College of Cardiology Scientific Sessions, New Orleans, LA, March 26, 2007.
L119)
“CKD and CVD: Interaction and Risk Factors”, Kidney Disease: The Unrecognized
Silent Killer, NKF 2007 Scientific Meetings, Orlando, FL, April 11, 2007.
L120)
“Contrast-Induced Nephropathy: A Meta-Analyses of the Renal Safety of Iodixanol”
Special Lecture for the Radiological Society of the Republic of China, National Yang-Ming
University, School of Medicine, Taipei, Taiwan, May 4, 2007.
L121)
“Contrast-Induced Nephropathy: A Meta-Analyses of the Renal Safety of Iodixanol”
Annual Meeting of Kaohsiung Society of Radiology, Chang Gung Memorial Hospital,
Kaohsiung Hsien, Taiwan, May 5, 2007.
L122)
”Meta-Analyses of the Renal Safety of Iodixanol”, Plenary Session, 15th Annual
Scientific Congress of the Hong Kong College of Cardiology, Hong Kong, SAR, May 6, 2007.
L123)
“Contrast-Induced Nephropathy: A Meta-Analyses of the Renal Safety of Iodixanol”
Cardiology Special Lecture, 12th Department of Cardiology, Beijing AnZhen Hospital, Beijing,
Peoples Republic of China, May 7, 2007.
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L124)
“Prevention of CIN during PCI in Diabetic Patients: Proposal of a Guideline"
(Prevencion del Fracaso Renal Inducido por Contraste en Pacientes Diabeticos Sometidos a
Intervencionismo Coronario: Propestuesta de un Protocolo Actuacion), Optimizacion del
Tratamiento de Revascularizacion Percutanea en Pacientes Diabeticos, TEAM (Terapia
Endovascular & Miocardica), Hospital del Mar, Barcelona, Spain, May 11, 2007.
L125)
“Acute Kidney Injury from Iodinated Contrast: Findings from an International Panel,”
Hungarian Society of Cardiology Annual Scientific Meeting (Magyar Kardiologusok Tarsasaga
Tudomanyos Kongresszusa) Balatonfured, Hungary, May 12, 2007.
L126)
“Which Types and Which Amount of Physical Activities to Achieve and Maintain a
Healthy Body Weight?” 4th Metabolic Syndrome, Type II Diabetes, and Atherosclerosis
Congress (MSDA), 2007, Lisbon, Portugal, May 19, 2007.
L127)
“The Role of BNP in Patients with Shortness of Breath,” Laboratory Diagnostic
Technologies for Patients with Shortness of Breath, Satellite Symposium to the American
Association of Clinical Chemistry Annual Scientific Meeting, San Diego, CA, July 18, 2007.
L128)
“Acute Kidney Injury after Contrast: A Serious Problem by Any Name”,
Hemodynamics, Electrolytes, Acute Kidney Injury: Novel Considerations in Contrast
Selection, Transcatheter Cardiovascular Therapeutics 2007 Annual Meeting Satellite
Symposium, Washington, DC, October 23, 2007.
L129)
“Vascular Calcification: Myth versus Realty: A Cardiologist's Perspective,” Changing
Paradigms: Evolving Bone and Mineral Metabolism Treatment in CKD, An American Society
of Nephrology 2007 Official Symposia, San Francisco, CA, November 3, 2007.
L130)
“Contrast-Induced Nephropathy” Cardiology Grand Rounds, Auckland City Hospital,
Auckland, New Zealand, November 22, 2007.
L131)
“Practical Use of Natriuretic Peptides in Cardiovascular Disease” North Shore
Hospital- Waitemata Health, Takapuna, Auckland, New Zealand, November 22, 2007.
L132)
“Practical Use of Natriuretic Peptides in Cardiovascular Disease” Waikato Hospital,
Hamilton, New Zealand, November 23, 2007.
L133)
“Practical Use of Natriuretic Peptides in Cardiovascular Disease” Wakefield Hospital,
Adelaide, Australia, November 23, 2007.
L134)
“Clinical Utilization of Cardiac Troponin and Natriuretic Peptides in ACS and CHF”
Satellite Symposium to Australasian Emergency Meeting (ACEM), Gold Coast, Brisbane,
Australia, November 27, 2007.
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L135)
“Clinical Utilisation of Cardiac Troponin and Natriuretic Peptides in ACS and CHF: Part
1: Congestive Heart Failure, Part 2: Acute Coronary Syndrome, Part 3: Cardio-Renal
Syndrome, Kuala Lumpur, Malaysia, November 29, 2007.
L136)
“Multimarker Strategies in the Management of Cardiovascular Emergencies,” YMCA
for Dr. H.F.Ho, Queen Elizabeth Hospital, Hong Kong, SAR, November 30, 2007.
L137)
“Practical Management of Cardiovascular Disease in Patients with Kidney Disease”
Williamsburg, Virginia for the 34th Annual Williamsburg Conference on Heart Disease,
Williamsburg, VA, December 3, 2007.
L138)
“New Cardiovascular Drugs” 17th Annual Cardiovascular Conference at Beaver
Creek” Avon, CO, February 12, 2008.
L139)
“New Insights into Atherosclerosis and Global CVD Risk,” 17th Annual Cardiovascular
Conference at Beaver Creek” Avon, CO, February 12, 2008.
L140)
“Plenary 2 : Mini-Symposia: Acute Kidney Injury (AKI): Pathophysiology: Contrast
Nephropathy: Epidemiology and Prognosis” 13th Annual International Conference on
Continuous Renal Replacement Therapies, San Diego, CA, February 28, 2008.
L141)
“Heart Failure and Cardio-Renal Syndrome 1: Pathophysiology” 13th Annual
International Conference on Continuous Renal Replacement Therapies, San Diego, CA,
February 29, 2008.
L142)
“Hemodynamic Monitoring: Principles and Practice” 13th Annual International
Conference on Continuous Renal Replacement Therapies, San Diego, CA, February 29, 2008.
L143)
“Cardiovascular Calcification, Potential Strategies in Minimizing Cardiovascular
Disease in CKD”, Satellite Symposia at the 57th ACC Annual Scientific Sessions, Chicago, IL,
March 30, 2008.
L144)
“Emergency Evaluation of Chest Pain: Building a Better Mousetrap” Olathe Medical
Center Annual Heartbeat Symposium, Olathe, KS, April 4, 2007.
L145)
“Interventions and CVD Interactions in Diabetics with Proteinuria” Satellite Symposia
(Chairman) Chronic Kidney Disease Interventions: Improving CKD and CVD Outcomes” NKF
Clinical Meeting 2008, Dallas, TX, April 5, 2008.
L146)
“Shifting Paradigms in PCI: Controversial Issues in High-Risk Patients” International
Symposium (Chairman), Barcelona, Spain, April 10, 2008.
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L147)
“Success in Identifying Heart Failure” Satellite Symposia “Managing CVD: What Every
Internist Needs to Know” Annual Scientific Sessions of the American College of Physicians,
Washington, DC, May 14, 2008.
L148)
“Cardiovascular Calcification in Patients with Chronic Kidney Disease” Satellite
Symposia “Cardiovascular Disease in CKD: Strategies for Minimizing Mortality” Annual
Scientific Sessions of the American College of Physicians, Washington, DC, May 15, 2008.
L149)
“Clinical Trial Designs in Contrast Induced Acute Kidney Injury,” Third Annual AKIN
Conference on Research Initiatives in AKI, Bethesda, MD, June 10-12, 2008.
L150)
“Neutrophil Gelatinase Associated Lipocalin (NGAL)” on Behalf of Inverness Medical,
Third Annual AKIN Conference on Research Initiatives in AKI, Bethesda, MD, June 10-12,
2008.
L151)
“Practical Strategies to Manage Contrast-induced Acute Kidney Injury (CI-AKI): The
Evidence and the Controversy” Radiological Society of Taiwan, Taipei, Taiwan, July 17,
2008.
L152)
“Practical Strategies to Manage Contrast-induced Acute Kidney Injury (CI-AKI): The
Evidence and the Controversy” Radiological Society of Taiwan, Kaushiung, Taiwan, July 18,
2008.
L153)
“Practical Strategies to Manage Contrast-induced Acute Kidney Injury (CI-AKI): The
Evidence and the Controversy” Contrast-Induced Nephropathy Symposium, Professor Yalin
Han, MD, Chairwoman of Military Cardiology Society of China, Shenyang, China, July 20,
2008.
L154)
Cardiology Teaching Rounds, with Professor Runlin Gao, Beijing Fuwai Hospital,
Beijing, China, July 21, 2008.
L155)
Cardiology Teaching Rounds, with Professor Yujie Zhou, Beijing Anzhen Hospital,
Beijing, China, July 21, 2008.
L156)
Cardiology Teaching Rounds with Professor Yundai Chen, General Hospital of
Military, Peoples Liberation Army, Beijing, China, July 21, 2008.
L157)
“Practical Strategies to Manage Contrast-induced Acute Kidney Injury (CI-AKI): The
Evidence and the Controversy” Contrast-Induced Nephropathy Symposium, Contrast-
Induced Nephropathy Symposium, Professor Runlin Gao, Chairman of Chinese Cardiology
Society, Beijing, China, July 22, 2008.K
L158)
“New Insights on Accelerated Vascular Calcification in Patients with Kidney Disease”
Plenary Session: Ischemic Heart Disease/Risk Assessment/New Treatment Strategies”
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International Academy of Cardiology 14th World Congress on Heart Disease, Annual
Scientific Sessions, Toronto, Ontario, Canada, July 29, 2008.
L159)
“Cardiorenal Syndrome: the Diagnostic Value of Brain Natriuretic Peptide and
Neutrophil Gelatinase Associated-Lipocalin in Interventional Cardiology,” Cardiovascular
Biomarkers which Enhance Clinical Practice in Emergency Medicine and Cardiology: the
State of the Art for Markers of Necrosis, Hemodynamic Stress and Cardiorenal Syndrome,
Satellite Symposium to the European Society of Cardiology Annual Scientific Sessions,
Munich, Germany, September 2, 2008.
L160)
“Diagnosis and Management of Diabetes, Hypertension, and Acute Dyspnea,” 2008
CVD and CKD Intersection Consensus Conference, Chicago, IL, September 26, 2008.
L161)
“Chronic Kidney Disease and Contrast Nephropathy (Contrast-Induced Acute Kidney
Injury [CI-AKI]): From Prognostic Scores to the Latest Preventive Strategies” Complex
Patients, Complex Lesions, 20th Annual Transcatheter Therapeutics Conference,
Washington, DC, October 14, 2008.
L162)
“Chronic Kidney Disease: a CHD Risk Equivalent” 2008 Cardiometabolic Health
Congress, Harvard Medical School, Boston, MA, October 19, 2008.
L163)
“Hyperphosphatemia as a Cardiovascular Risk Factor” Nephrology Conference, The
Ottawa Hospital, Ottawa, Ontario, Canada, October 28, 2008.
L164)
“Cardiovascular Calcification in Patients with Chronic Kidney Disease” Nephrology
Division-Wide Conference, The Ottawa Hospital, Ottawa, Ontario, Canada, October 28,
2008.
L165)
“Hyperphosphatemia and CVD Risk,” Management of Hyperphosphatemia Across the
Continuum of CKD, American Society of Nephrology Satellite Symposium, Philadelphia, PA,
November 8, 2008.
L166)
“Cardiovascular Calcification” Nephrology Grand Rounds, Humber River Regional
Hospital, Toronto, Ontario, Canada, December 9, 2009.
L167)
“Cardiovascular Calcification” Nephrology Grand Rounds, St. Joseph’s Hospital,
Toronto, Ontario, Canada, December 9, 2009.
L168)
“Critical Concepts in the Progression of Atherosclerosis” 18th Annual Cardiovascular
Conference at Beaver Creek, Beaver Creek, CO, February 9, 2009.
L169)
“New Molecular Targets in the Treatment of Atherosclerosis” 18th Annual
Cardiovascular Conference at Beaver Creek, Beaver Creek, CO, February 9, 2009.
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L170)
“Sudden Cardiac Death in Patients with Renal Disease” 18th Annual Cardiovascular
Conference at Beaver Creek, Beaver Creek, CO, February 12, 2009.
L171)
“Cardiovascular and Renal Implications of Contrast Media” Radiology Grand Rounds,
The Kingston Hospital, Queens University School of Medicine, Kingston, Ontario, Canada,
March 3, 2009.
L172)
“Recent Evidence into the Pathophysiology of Cardiovascular Calcification in Chronic
Kidney Disease,” NKF Symposium 2009 Spring Clinical Meetings, “Exploring Recent
Evidence Related to Cardiovascular Calcification and Chronic Kidney Disease”, Nashville, TN,
March 27, 2009.
L173)
“Chronic Kidney Disease: Implications For Patients With CAD” Managing the High Risk
Coronary Patient, I2 Summit, American College of Cardiology Annual Scientific Sessions,
Orlando, FL, March 30, 2009.
L174)
“BNP and Cardiovascular Disease” Cardiology Grand Rounds, Hospital PróCardíaco,
Rio deJaniero, Brasil, April 14, 2009.
L175)
“Acute Cardiac Effects of Marathon Running” Special Guest Lecture, CLINIMEX -
Clínica de Medicina do Exercício, Rio deJaniero, Brasil, April 14, 2009.
L176)
“Interface entre doenca renal e cardiovascular: o rim mata o coracao ou o coracao
mata o rim? Da para evitar esse extermino?” Terapeutica Cardiovascular International,
Hospital Espanhol, Salvador, Brasil, April 17, 2009.
L177)
“A angiotomografia coronaria deve ser empregada em todo paciente com do toracica
de risco baixo-moderado?” Terapeutica Cardiovascular International, Hospital Espanhol,
Salvador, Brasil, April 17, 2009.
L178)
“Conferencia Internacional: Opportunidades para aperfeicoar o tratamento da
insuficiencia cardiaca avancada/descompensada” Terapeutica Cardiovascular International,
Hospital Espanhol, Salvador, Brasil, April 17, 2009.
L179)
“Invasive Versus Non-invasive Coronary Angiography: Guidelines for Achieving
Optimal Outcomes” Annual Scientific Sessions of the Society for Cardiac Angiography and
Intervention, Las Vegas, NV, May 7, 2009.
L180)
“Cardiorenal Syndrome” Moderator, American Society of Nephrology Annual
Scientific Sessions, Renal Week 2009, San Diego, CA, October 29, 2009.
L181)
“The Creatinine Changes: Now What?” Cardiorenal Syndromes, Annual Scientific
Sessions, AHA, Orlando, FL, November 16, 2009.
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L182)
“Cardiorenal Syndromes: Strategies for Success” 19th Annual Cardiovascular
Conference at Beaver Creek, Avon, CO, February 6-11, 2010.
L183)
“Cardiomyopathy of Obesity” 19th Annual Cardiovascular Conference at Beaver
Creek, Avon, CO, February 6-11, 2010.
L184)
“Why Does Atherosclerosis Calcify: Clinical Implications” 19th Annual Cardiovascular
Conference at Beaver Creek, Avon, CO, February 6-11, 2010.
L185)
“Prevention Trials in AKI” 15th International Conference on Continuous Renal
Replacement Therapies (CRRT: 2010) Scientific Meeting, Del Coronado, CA, February 24,
2010.
L186)
“Cardiology Trials” 15th International Conference on Continuous Renal Replacement
Therapies (CRRT: 2010) Scientific Meeting, Del Coronado, CA, February 24, 2010.
L187)
“Contrast Nephropathy: Prevention and Management” 15th International
Conference on Continuous Renal Replacement Therapies (CRRT: 2010) Scientific Meeting,
Del Coronado, CA, February 26, 2010.
L188)
“Lipoprotein-Associated Phospholipase A2 (Control#: 4599)” Symposium: Do New
Markers & Genomics Enhance Risk Prediction? Annual Scientific Sessions of the ACC,
Atlanta, GA, March 15, 2010.
L189)
“New Insights Into the Role of Heart-Kidney Interactions in the Cardiorenal
Syndrome” (Control#: 16660) Symposium: Recognition and Management of the Cardiorenal
Syndrome in Advanced Heart Failure, Annual Scientific Sessions of the American College of
Cardiology, Atlanta, GA, March 15, 2010.
L190)
“B-Type Natriuretic Peptides in Cardiorenal Syndromes” 5th Annual Turning Science
into Caring Symposium, Wiesbaden, Germany, March 25, 2010.
L191)
“CKD and CVD Interaction in KEEP” KEEP Update: the Common Soil of CKD and CVD,
NKF Spring Clinical Meetings, Orlando, FL, April 16, 2010.
L192)
“Cardio Renal Intersection, Crossroads to the Future - Novel Coronary Risk Factors"
NKF Spring Clinical Meetings, Orlando, FL, April 16, 2010.
L193)
“Diagnostic Workup of suspected heart disease in CKD” NKF Spring Clinical Meetings,
Orlando, FL, April 17, 2010.
L194)
“BNP: Beyond Heart Failure (BNP más allá de la insuficiencia cardiaca)”, XIX Chile
2010 Congreso Latinoamericano de Bioquimica Clinica, XVI Congreso Chileno de Quimica
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Clinica, Biomarcadores en Enfermedades Cario-Renales COLABIOCLI 2010, Santiago del
Chile, April 21, 2010.
L195)
“Prevention of Cardiorenal Syndromes”, 19th International Vicenza Course on Critical
Care Nephrology, Vicenza, Italy, June 10, 2010.
L196)
“La Pandemia de la Obesidad: Que podemos hacer aquí y ahora” “Importancia de la
Evaluación previa y el monitoreo cardiaco en rehabilitación cardiaca” “Ergoespirometria:
Diagnostico e implicaciones terapéuticas,” Sociedad Columbiana de Cardiologica y Ciruga
Cardiovacular Fundacion Columbiana del Corazon Comite de Prevencion y Rebabilitacion
Cardiovascular Dia Mundial del Corazon, Santa Marta, Columbia, September 25, 2010.
L197)
“CKD: A CHD Equivalent” 2010 Cardiometabolic Health Congress (CMHC), Boston
MA, October 22, 2010.
L198)
“Treatment Disparities in Patients with Acute Coronary Syndromes and Kidney
Disease” AHA Scientific Sessions 2010, Chicago, IL, November 13, 2010.
L199)
“Integration of Advanced Information Technology into Nephrology Practice”
Moderator, at the American Society of Nephrology, Denver, CO, November 21, 2010.
L200)
“Cardiorenal Syndromes” Special Lecture, Mansoura Nephrology and Urology
Center, Mansoura, Egypt, November 29, 2010.
L201)
“Neutrophil Gelatinase Associated Lipocalin.” Al Mokhtabar Laboratories, Cairo,
Egypt, December 1, 2010.
L202)
“Cardiorenal Syndromes” ACC Williamsburg Conference, Williamsburg, VA,
December 5, 2010.
L203)
“Micronutrients and Cardiorenal Disease: Insights into Novel Assessments and
Treatment” 13th International Conference on Dialysis, Advances in CKD 2011, Miami, FL,
January 26, 2011.
L204)
“Managing High Risk Patients in a i2 Spotlight entitled Cardiac Care Team Spotlight:
Approaches for CAD Management” American College of Cardiology 60th Annual Scientific
Session and i2 Summit 2011, April 2, 2011, in New Orleans, LA.
L205)
“Lipid Management in Patients with Renal Insufficiency in a ACC Symposium entitled
Lipid Management in Special Populations” American College of Cardiology 60th Annual
Scientific Session and i2 Summit 2011, April 2, 2011, in New Orleans, LA.
L206)
“KEEP Symposium 2011: KEEP A New Longitudinal Dimension for a New Decade”
NKF Spring Clinical Meetings, April 29, 2011, Las Vegas, NV.
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L207)
“Disparities of Treatment for ACS and Heart Failure in CKD Patients” 20th
International Vicenza Course on Hemodialysis and CKD, June 8, 2011, Vicenza, Italy.
L208)
“AKI: Can We Prevent It?” 20th International Vicenza Course on Hemodialysis and
CKD, June 9, 2011, Vicenza, Italy.
L209)
“Measuring Natriuretic Peptides in Acute Coronary Syndromes” American
Association of Clinical Chemistry Annual Meeting, Atlanta, GA, July 26, 2011.
L210)
“Biomarkers in Stable Angina and Microvascular Dysfunction”, Emerging Role of
Biomarkers in Cardiorenal Syndrome and Acute Coronary Syndrome: Diagnosis
Stratification and Management, Siena Italy, September 2, 2011.
L211)
“Cardiorenal Syndrome Definition and Scope: Cardiac Perspective” 28th National
Congress of Nephrology, Hypertension, Dialysis, and Transplantation, Antalya, Turkey,
October 20, 2011.
L212)
“Targeted Hypertension Management for Optimal Cardiorenal Outcomes” 28th
National Congress of Nephrology, Hypertension, Dialysis, and Transplantation, Antalya,
Turkey, October 22, 2011.
L213)
“The KEEP Experience” 3rd International Symposium on Albuminuria – The
Prognostic Role of Albuminuria: Impact on Kidney and Cardiovascular Outcomes,
Groningen, Netherlands, December 1, 2011.
L214)
“Cardiorenal Syndromes” Cardiology Guest Lecture, University of Chicago, Pritzker
School of Medicine, Chicago, IL, January 18, 2012.
L215)
“Diagnosis of Cardiovascular Disease in CKD” 14th international conference on
dialysis, advances in CKD 2012, Palm, Harbor, FL, January 26, 2012
L216)
“Acute Kidney Injury Guidelines” KDIGO Clinical Practice Conference: KDIGO
Guidelines on Acute Kidney Injury, Glomerulonephritis, and Anemia, Shanghai, China,
February 5, 2012
L217)
“Galectin-3: A Novel Blood Test for the Evaluation and Management of Heart
Failure” Cardiology Grand Rounds, University of Arkansas for Medical Sciences, Little Rock,
Arkansas, February 8, 2012
L218)
“Contrast-Induced Acute Kidney Injury” 17th Annual CRRT 2012, Acute Kidney Injury
Controversies, Challenges, and Solutions, San Diego, CA February 15, 2012
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L219)
“Recent Trials in the Prevention of Contrast-Induced AKI: Importance of Emerging
Biomarkers” 17th Annual CRRT 2012, Acute Kidney Injury Controversies, Challenges, and
Solutions, San Diego, CA February 17, 2012
L220)
“Role of Galectin-3 in Heart Failure” Joint American Association of Cardiologists of
Indian Origin and ACC Dinner Symposium, American College of Cardiology Scientific Sessions
2012, Chicago, IL, March 25, 2012
L221)
“Bariatric Surgery: A Cure for Obesity?” American College of Cardiology Scientific
Sessions 2012, Joint Symposium of the American Association of Clinical Endocrinologists and
the ACC: Cardiologists as Endocrinologists – Emerging Management of the Diabetic Patient,
Chicago, IL, March 26, 2012
L222)
“Practical Management of Obesity for the Cardiologist” 48th Annual Robert M.
Jeresaty Cardiovascular Symposium, Hartford, CT, May 3, 2012
L223)
“Prevention of Cardiovascular Events: Beyond Statins” 48th Annual Robert M.
Jeresaty Cardiovascular Symposium, Hartford, CT, May 3, 2012
L224)
“Contrast Media and Patient Safety: The Clinical Impact” Swiss Congress of Radiology,
Zurich, Switzerland, May 31, 2012
L225)
“Importance of Methodological Rigor in CI-AKI Meta-Analyses” 48th Congresso
Nazionale Italian Society of Radiology (SIRM), Torino, Italy, June 2, 2012
L226)
“Chronic Kidney Disease and Heart Failure” 2012 Cardiometabolic Health Congress
(CMHC) Boston, MA, October 12, 2012
L227)
“Chronic Kidney Disease and Acute Myocardial Infarction” CKD a Recipe for CVD
Disaster, Kidney Week, American Society of Nephrology, San Diego, CA, October 30, 2012
L228)
“Epidemiology and Pathophysiology of Coronary Artery Disease in Chronic Kidney
Disease” Scientific Sessions 2012, AHA, Los Angeles, CA, November 5, 2012
L229)
“The Cardiorenal Syndrome” Acute Dialysis Quality Initiative 11: Cardiorenal
Syndromes, Venice, Italy, November 30, 2012
L230)
“Cardiorenal Syndromes” Cardiology Grand Rounds, University of Missouri School of
Medicine, Columbia, MO, December 20, 2012
L231)
“Diagnosis and Management of Coronary Disease in Patients with Kidney Disease”
Internal Medicine Grand Rounds, University of Missouri School of Medicine, Columbia, MO,
December 20, 2012
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L232)
“The Hypertension Epidemic: Are We Any Further Ahead?” 22nd Annual
Cardiovascular Conference at Beaver Creek, Avon, CO, February 9-16, 2013
L233)
“Cardiorenal Syndromes: The Cardiac Perspective” Inaugural Cardio Renal Society of
America (CRSA), 14th Annual Southwest Nephrology Conference (SWNC), Chandler, AZ,
March 2, 2013
L234)
"Managing Hyponatremia in Cardiorenal Syndromes" Satellite Symposia to the NKF
Spring Clinical Meetings, Orlando, FL, April 3, 2013
L235)
“Session Title: Debate: To Screen or Not to Screen for CKD--PRO? NKF Spring Clinical
Meetings, Orlando, FL, April 5, 2013
L236)
“Galectin-3: A Novel Biomarker for the Assessment and Management of Heart
Failure” Heart Failure Conference, University of Pittsburgh Medical Center, Pittsburgh, PA,
May 28, 2013
L237)
“The Kidney in Heart Failure” 31st International Vicenza Course on Critical Care
Nephrology, June 11-14, 2013, Vicenza, Italy
L238)
“Contrast-Induced Acute Kidney Injury” 31st International Vicenza Course on Critical
Care Nephrology, June 11-14, 2013, Vicenza, Italy
L239)
“Novel Biomarkers in the Prognosis and Management of Heart Failure” BUMC
Medicine Grand Rounds, August 20, 2013, Dallas, TX
L240)
“Cardiorenal Syndromes: New Insights into Combined Heart and Kidney Failure”
Cardiology Grand Rounds, University of Virginia Medical Center, August 26, 2013,
Charlottesville, VA
L241)
“Major Advances in the Treatment of Atherosclerosis: New Options for Patients with
Familial Hypercholesterolemia and Those Intolerant to Conventional Lipid Lowering
Therapy” Cardiology Update, University of Missouri School of Medicine, September 14,
Columbia, MO
L242)
“Keynote Address: Recent Advances in the Assessment of Acute Kidney Injury with
Neutrophil Gelatinase Associated Lipocalin” 47th Brazilian Congress of Clinical Pathology
and Laboratory Medicine, September 23, 2013, Sao Paulo, Brazil.
L243)
“Advancements in Cardiometabolic Risk Assessment: Expert Analysis of Recent
Evidence and Outcomes” 2013 Cardiometabolic Health Congress, October 2, 2013, Boston,
MA.
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L244)
“Keynote Address: Cardiorenal Syndromes: New Insights to Patients with Combined
Heart and Kidney Failure” Fourth Italian Great Network Congress, Focus on Innovation and
Translational Research in Emergency Medicine, Sapienza Universita di Roma, October 14-18,
2013, Rome, Italy.
L245)
“Practical Experience with Galectin-3” Fourth Italian Great Network Congress, Focus
on Innovation and Translational Research in Emergency Medicine, Sapienza Universita di
Roma, October 14-18, 2013, Rome, Italy.
L246)
“Using Novel Biomarkers in the Assessment and Management of Heart Failure” Bon
Secours Cardiovascular Conference, October 25, 2013, Williamsburg, VA
L247)
“Detection and Consequences of Iron Deficiency Anemia in CKD Patients” Session
Title: The Role of Iron in the Optimization of Anemia Management in CKD, American Society
of Nephrology, Kidney Week, November 9, 2013, Atlanta, GA
L248)
“Bench to Bedside: What Happens to the Physiologic Systems After an Acute Bout of
High Intensity/Volume Exercise?” Session Title: Cardiovascular Seminar entitled Potential
Cardiotoxicity of Extreme Endurance Exercise, Annual Scientific Sessions of the AHA,
November, 20, 2013, Dallas, TX.
L249)
“Atrasentan for the treatment of diabetic nephropathy: how to control the risk of
heart failure?” Session Title: “Lessons Learned from First Post FDA Guidance Case Studies
of Diabetes CV Outcomes Trials, 10th Global CardioVascular Clinical Trialists (CVCT) Forum,
December 7, 2013, Paris, France.
L250)
“Reflection: Biomarker-based modeling tools: safer drugs and faster development?”
A workshop initiated by the TI-Pharma Escher project for academia, industry, and the
European Medicines Agency, January 24, 2014, Amsterdam, the Netherlands.
L251)
“Focus on lipids: HDL and Its Associated Lipoproteins in Cardiac and Renal Disease”
Changing Paradigms in Acute Kidney Injury: From Mechanisms to Management Sponsored
by UAB/UCSD O’Brien Center for AKI Research, 19th International Conference on Advances
in Critical Care, CRRT 2014, International Society of Nephrology, Acute Kidney Injury
Network, March 4-7, 2014, San Diego, CA.
L252)
“Cardiac and Renal Fibrosis in Chronic Cardiorenal Syndromes” Targeting Recovery
from Acute Kidney Injury:, 19th International Conference on Advances in Critical Care, CRRT
2014, International Society of Nephrology, Acute Kidney Injury Network, March 4-7, 2014,
San Diego, CA.
L253)
“Statins for AKI: Friend or Foe” Controversies in Critical Care Nephrology:, 19th
International Conference on Advances in Critical Care, CRRT 2014, International Society of
Nephrology, Acute Kidney Injury Network, March 4-7, 2014, San Diego, CA.
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L254)
“Managing Heart Failure and Cardiorenal Syndrome” Workshop, 19th International
Conference on Advances in Critical Care, CRRT 2014, International Society of Nephrology,
Acute Kidney Injury Network, March 4-7, 2014, San Diego, CA.
L255)
“ST2: A Novel Biomarker in the Assessment and Management of Heart Failure” 2nd
Annual Cardio Renal Society of America (CRSA), 15th Annual Southwest Nephrology
Conference (SWNC), Ft. McDowell, AZ, March 8, 2014.
L256)
“Cardiac and Renal Fibrosis in Chronic Cardiorenal Syndromes” 2nd Annual Cardio
Renal Society of America (CRSA), 15th Annual Southwest Nephrology Conference (SWNC),
Ft. McDowell, AZ, March 8, 2014.
L257)
“New Approaches to the Management of Cardiorenal Syndromes” 2nd Annual Cardio
Renal Society of America (CRSA), 15th Annual Southwest Nephrology Conference (SWNC),
Ft. McDowell, AZ, March 8, 2014.
L258)
“My New Favorite Biomarker: Galectin-3” 2014 UCSD Biomarkers in Clinical Practice
Symposium, La Jolla, CA, April 5, 2014.
L259)
“Changing Profile of Chronic Hyperkalemia” NKF Spring Clinical Meetings, Las Vegas,
NV, April 24, 2014.
L260)
“The Next Generation of Screening for Kidney Disease” NKF Spring Clinical Meetings,
Las Vegas, NV, April 25, 2014.
L261)
“Cardiorenal Syndromes” Cardiology, Diabetes & Nephrology at the Limits, Royal
College of Physicians, London, UK, April 26, 2014.
L262)
“Acute Cardiorenal Syndromes: New Insights into Combined Heart and Kidney
Failure” Actual Problems of Extracorporeal Blood Purification in Intensive Care, Russian
Scientific Society of Specialists in Extracorporeal Blood Purification, Bakoulev Scientific
Center for Cardiovascular Surgery of the Russian Academy of Medical Sciences, Moscow,
Russia, May 22, 2014.
L263)
"Fibrosis in the Heart and Kidneys in the Pathogenesis of Chronic Cardiorenal
Syndromes" Actual Problems of Extracorporeal Blood Purification in Intensive Care, Russian
Scientific Society of Specialists in Extracorporeal Blood Purification, Bakoulev Scientific
Center for Cardiovascular Surgery of the Russian Academy of Medical Sciences, Moscow,
Russia, May 23, 2014.
L264)
“Hyperkalemia: Old Foe with New Faces” 51st European Renal Association – European
Dialysis and Transplantation Association Congress, Amsterdam, the Netherlands, June 2,
2014.
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L265)
“Contrast Induced Complications in the Cath Lab” Transcatheter Cardiovascular
Therapeutics (TCT) Russia, Moscow, Russia, June 16, 2014.
L266)
“The RAASi Debate: Should RAAS Continue with a Declining GFR?: Will the Path be
Clearer” Co-Chair, European Society of Cardiology, Barcelona, Spain, August 31, 2014.
L267)
“Novel Markers of Acute and Chronic Kidney Injury,” Where Inflammation Meets
Lipids: Broad Based Strategies for Risk Reduction, Cleveland Heart Labs, Cleveland, OH,
September 12, 2014.
L268)
“Advances in the Understanding of Acute and Chronic Cardiorenal Syndromes:
Pathophysiological Crosstalk of Multiple Metabolic and Neurohormonal Systems” 41st
Williamsburg Cardiovascular Conference, Williamsburg, VA, December 7, 2014.
L269)
“CHADS, CHADS-VASc, HAS-BLED, What Does it Mean and How Do We Use It? Atrial
Fibrillation Session, Dallas-Leipzig Valve 2104, Dallas, TX, December 11, 2014.
L270)
“Soup-to-Nuts Renal Failure: Caring for the Patient with Kidney Injury” Society of
Critical Care Medicine, Phoenix, AZ, January 19, 2015.
L271)
“RAASi Optimization in Heart Failure” 2nd Annual Cardiorenal Society of America
Meeting, Phoenix, AS, February 28, 2015.
L272)
“Cardiac Surgery Associated Acute Kidney Injury” Association of Physician Assistants
in Cardiac Surgery, Las Vegas, NV, March 3, 2015.
L273)
“The Potassium Challenge in CKD: Managing Acute and Chronic Hyperkalemia: Novel
Polymer-Based Potassium Binders: Clinical Evidence” NKF Spring Clinical Meetings, March
27, 2015.
L274)
“KEEP Healthy: Insights into CKD Care” NKF Spring Clinical Meetings, March 28, 2015.
L275)
“The Heart of the Matter” NKF Spring Clinical Meetings, March 28, 2015.
L276)
“Literature Review: CVD” NKF Spring Clinical Meetings, March 28, 2015.
L277)
“Biomarkers of Kidney and Heart Injury in Cardiorenal Syndrome” Cardionephrology
2015, Rome, Italy, April 16, 2015.
L278)
“AKI after Acute Myocardial Infarction: Contrast, Organ Crosstalk and Complications”
33rd Vicenza Course on Critical Care Nephrology in Vicenza, Italy, June 9-12, 2015.
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L279)
“A New Mechanism of Action for Addressing Hyperkalemia: New Data on Non-
Polymer Hyperkalemia Therapies” 33rd Vicenza Course on Critical Care Nephrology in
Vicenza, Italy, June 9-12, 2015.
L280)
“Lp-PLA2 as a marker of Vascular Inflammation and CHD Risk Assessment”
Symposium: Advances in Laboratory Testing for Coronary Heart Disease; The New PLAC
Test for Lp-PLA2 Activity, American Association of Clinical Chemistry Annual Meeting,
Atlanta, GA, June 29, 2015.
L281)
“Galectin-3 in the Prognosis and Management of Heart Failure” American
Association of Clinical Chemistry Annual Meeting, Atlanta, GA, June 29, 2015.
L282)
“Cardio-Renal Syndrome and Clinical Implications” AKI from Pathophysiology to
Clinical Implications, Global Research on Acute Conditions Team (GREAT) Annual Meeting,
Rome, Italy, September 5, 2015.
L283)
“Lp-PLA2 and Testing for Primary Prevention Risk Assessment” 2015 Cardiometabolic
Health Congress, Harvard Medical School, Boston, MA, October 22, 2015.
L284)
“Heart and Kidney: a Dangerous Liaison” Comorbidities in Heart Failure: From
Guidelines to Clinical Practice, 775 Anniversary University of Sienna, Sienna, Italy, October
29, 2015.
L285)
“Role of BNP, Pro-BNP, and Elevated Left Ventricular Mass in Cardiorenal Syndrome”
American Society of Nephrology Kidney Week, San Diego, CA, November 6, 2015.
L286)
“How to Use Urine Thromboxane B2 to Select and Monitor Aspirin Therapy”
Moderator, Scientific Sessions 2015, AHA, Orlando, FL, November 10, 2015.
L287)
“Putting it All Together: How to Use Urine 11-Dehydrothromboxane B2
In Clinical Practice” Scientific Sessions 2015, AHA, Orlando, FL, November 10, 2015.
L288)
“Neurogenic Orthostatic Hypotension” Moderator, Scientific Sessions 2015, AHA,
Orlando, FL, November 10, 2015.
L289)
“Cardiac Cachexia” Managing Disease Related Lean Body Mass Loss Through Clinical
and Nutritional Interventions, The Sackler Institute for Nutrition Science The New York
Academy of Sciences, New York, NY, December 4, 2015.
L290)
“The Devastating Consequences of Systemic Hypertension and What To Do About
It?” 42st Williamsburg Cardiovascular Conference, Williamsburg, VA, December 6-8, 2015.
L291)
“The Impact and Management of Malnutrition in Patients with Heart Failure” Heart
Failure University 2015, Conference Co-Chair, Los Angeles, CA, December 11-13, 2015.
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L292)
“Acute and Chronic Cardiovascular Effects of Hyperkalemia: New Insights Into
Prevention and Clinical Management” Heart Failure University 2015, Conference Co-Chair,
Los Angeles, CA, December 11-13, 2015.
L293)
“Lipoic Acid in the Prevention of Acute Kidney Injury” 21st International Conference
on Continuous Renal Replacement Therapies CRRT 2016, San Diego, CA, February 16-18,
2016.
L294)
“Novel Approaches for Recognition and Management of Life Threatening
Complications of AKI and CKD” 21st International Conference on Continuous Renal
Replacement Therapies CRRT 2016, San Diego, CA, February 16-18, 2016.
L295)
“Making Iodinated Contrast Less Nephrotoxic with Cyclodextrin” 21st International
Conference on Continuous Renal Replacement Therapies CRRT 2016, San Diego, CA,
February 16-18, 2016.
L296)
“Cardiorenal Syndrome” 4th Annual Cardio-Renal Metabolic Conference, Cardiorenal
Society of America, Phoenix, AZ, March 13, 2016.
L297)
“Cardiorenal Syndromes Identification: Prevention and Management of CI-AKI” China
Interventional Therapeutics (CIT), Beijing, Shanghai Zhong Shan Hospital, Shanghai, The 2nd
Affiliated Hospital of Zhejiang University, Hangzhou, Xi Jing Hospital, Xi’an, Nanjing 1st
Hospital, Nanjing, Peoples Republic of China, March 14-21, 2016.
L298)
“Cardiorenal Syndromes” Keynote Address, Inaugural Cardio-Renal Connections
Meeting, San Antonio, TX , April 16, 2016.
L299)
“Galectin-3 in the Prognosis and Management of Heart Failure” American
Association of Clinical Chemistry Annual Scientific Meeting, Philadelphia, PA, August 1,
2016.
L300)
Hemodialysis University, “Is It Heart Failure or Fluid Overload?”, Chicago, IL,
September 10, 2016.
L301)
“Novel Agents for the Treatment of Hyperkalemia” Heart Failure Society of America
Annual Scientific Meeting, Orlando, FL, September 18, 2016.
L302)
Symposium “Hyperkalemia in the Emergency Department: Updates on the Current
Management of a Complex Condition.” “Novel Agents for the Prevention and Treatment of
Hyperkalemia” American College of Emergency Physicians Scientific Assembly, Las Vegas,
NV, October 14, 2016
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L303)
Moderator “CVD in Patients with CKD: Update from the CRIC Study” Annual Scientific
Sessions of the AHA, New Orleans, LA, November 13, 2016
L304)
Program Chairman “A Night at the Museum: Inaugural Symposium of the
Cardiorenal Society of America Transcending the Dinosaurs: Guiding AKI Prevention using
next-gen biomarkers: Real World Experiences from modern practices” satellite Symposium
at American Society of Nephrology Kidney Week, Field Museum, Chicago, IL, November 18,
2016
L305)
“Pathobiologic Systems Involved in Cardiorenal Disease” 43rd Williamsburg
Cardiovascular Conference, Williamsburg, VA, December 3-5, 2016
L306)
“Cardiac Cachexia” Heart Failure University, MedReviews LLC, Los Angeles, CA,
December 10, 2016
L307)
“Is There a Role for Bariatric Surgery in Heart Failure Patients with Obesity?”
Scientific Sessions 2017, American College of Cardiology , Washington, DC, March 18, 2017
L308)
“Vascular and Cardiac Hypertrophy in Fabry Disease” 5th Annual Fabry Nephropathy
Update, Mexico City, Mexico, April 26, 2017
L309)
“Introduction to Cardiorenal Medicine” Cardiorenal University, Anaheim, CA, May
18, 2017
L310)
“Sudden Death in End-Stage Renal Disease” Cardiorenal University, Anaheim, CA,
May 18, 2017
L311)
“Cardiorenal Syndromes and Heart Failure” Conference Chair, Disease Global
Outcomes (KDIGO) Controversies Conference on Heart Failure in Chronic Kidney Disease,
Athens, Greece, May 25-28, 2017
L312)
“Vadadustat Does Not Prolong Corrected QT Interval In A Thorough QTC Study In
Healthy Subjects” 54th ERA-EDTA Congress, Madrid, Spain, June 3-6, 2017
L313)
“Cardiorenal Syndromes” 1st Annual Heart iN Diabetes: Where the Heart, Kidney,
and Diabetes Meet in Clinical Practice, Philadelphia, PA, July 14-16, 2017
L314)
“Cardiovascular Disease in Patients with Chronic Kidney Disease: A Serious Link” TOP
2017--Target Organ Protection Conference, Bangalore, India, August 11, 2017
L315)
“Statin Therapy to Prevent Onset and Progression of Vascular Disease” TOP 2017--
Target Organ Protection Conference, Bangalore, India, August 11, 2017
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L316)
“Keynote Address: Cardiorenal Society of America” 5th Annual Scientific Meeting of
the Cardiorenal Society of America, Phoenix, AZ, October 6, 2017
L317)
“Cardiovascular Benefits of Home Hemodialysis” Addressing Unmet Needs in Dialysis:
Cardiovascular Care and Volume Control Symposium, Kidney Week 2017 American Society
of Nephrology, New Orleans, LA, November 4, 2017
L318)
“CIEDs in ESRD Patients: What Are the Long-Term Data?” Kidney Week 2017
American Society of Nephrology, New Orleans, LA, November 4, 2017
L319)
“Cardiovascular Seminar Cardiorenal Syndrome: Who hurts who?” AHA Scientific
Sessions 2017, Anaheim, CA, November 14, 2017
L320)
“Cardiac and Renal Fibrosis in CRS” AHA Scientific Sessions 2017, Anaheim, CA,
November 14, 2017
L321)
Chair, Inaugural Cardiometabolic University and Nutrition Academy “The Skinny on
Weight Loss: Practical Considerations for the Cardiovascular Specialist” MedReviews,
Westlake, TX, December 1-3, 2017
L322)
“Clinical Laboratory Advancements in Cardiometabolic Disease: Screening, Diagnosis,
Prognosis, and Management” 44th Annual Williamsburg Conference on Heart Disease,
Williamsburg, VA, December 4, 2017
L323)
“The Skinny on Weight Loss: Practical Approaches for the Cardiovascular Specialist”
Cardiometabolic University 2017, Conference Chair, Dallas, TX , December 1-3, 2017
L324)
“Diagnosis, Evaluation, and Role of Biomarkers in Heart Failure” Heart Failure
University 2017, Conference Co-Chair, Los Angeles, CA, December 10-12, 2017
L325)
“Biomarkers of Kidney Dysfunction and Cardiorenal Syndrome” University of
California at San Diego 14th Annual Biomarkers in Heart Failure and Acute Coronary
Syndromes: Diagnosis, Treatment and Devices, San Diego, CA, March 2, 2018
L326)
“What do I do to Prevent Contrast Induced Renal Injury” 23rd International
Conference on Continuous Renal Replacement Therapies CRRT 2018, San Diego, CA, March
8, 2018
L327)
“AKI in the patient with Cancer” 23rd International Conference on Continuous Renal
Replacement Therapies CRRT 2018, San Diego, CA, March 8, 2018.
L328)
“CKD-Related Anemia and Cardiac Complications” NKF Spring Clinical Meetings,
Austin, TX April 14, 2018
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L329)
“Principles of Distributive Shock” Cardiorenal Society of America National Grand
Rounds Series, Boston, MA, April 30, 2018
L330)
“Biomarkers with More Muscle: Moving Beyond Serum Creatinine to Define
Cardiorenal Syndrome in HF” Heart Failure Society of American Annual Scientific Sessions,
Nashville, TN, September 15, 2018
L331)
“Heart Failure in Cardiorenal Syndrome: Updates on Biomarkers” Cardiorenal Society
of America Annual Scientific Meeting, Phoenix, AZ, October 6, 2018
L332)
“Novel Approaches in Lowering LDL-C” Cardiorenal Society of America Annual
Scientific Meeting, Phoenix, AZ, October 6, 2018
L333)
“What Do We Know About Cardiorenal Physiology? An Overview” American Society
of Nephrology Kidney Week, San Diego, CA, October 26, 2018
L334)
“Prevention of Heart Failure: The Next Frontier” Cardiometabolic Health
Conference, Boston, MA, October 27, 2018
L335)
“AKI and Heart Failure: How to Manage Compared to the General Population”
Cardiometabolic Health Conference, Boston, MA, October 27, 2018
L336)
“SGLT-2 Inhibitors and Cardio-renal Outcomes: Mechanistic Role and Rationale for
Treatment of Heart Failure” American Heart Association Annual Scientific Sessions,
Chicago, IL, November 10, 2018
L337)
“Obesity and Heart Disease” 44th Annual Williamsburg Conference on Heart Disease,
Williamsburg, VA, December 4, 2018
L338)
“Current Concepts in Hypertension Management” University of Texas Health Science
Center, Tyler, TX, January 15, 2019
L339)
“Managing the Heart Failure Patient with Worsening Renal Function (WRF)” 24th
International Conference on Continuous Renal Replacement Therapies CRRT 2019, San
Diego, CA, February 28, 2019
L340)
“Cardiorenal Syndrome: What Have We Learned?” 24th International Conference on
Continuous Renal Replacement Therapies CRRT 2019, San Diego, CA, February 28, 2019
L341)
” Debate: Biomarker Guided Heart Failure Therapy: Con: Neuropeptides; ST2” 15th
Annual USCD Biomarkers in Heart Failure and Acute Coronary Syndromes, Diagnosis,
Treatment & Devices, La Jolla, CA March 1, 2019
L342)
“Cardiorenal Syndromes” Cardionephrology Congress, Rome, March 12 to 14, 2019
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L343)
“Iron and Heart Failure” Cardiometabolic Health Congress West meeting in Phoenix,
AZ on Saturday, May 4, 2019
L344)
“Up to Date Management of Arrhythmias in Dialysis Patients” National Kidney
Foundation Spring Clinical Meetings, May 11, 2019
L345)
“Lipids in Chronic Kidney Disease” National Kidney Foundation Spring Clinical
Meetings, May 11, 2019
L346)
“Cardiorenal Syndromes” Helen Dunham Cardio-Renal Lecture and Cardiovascular
Grand Rounds, Brigham and Women’s Hospital, Boston, MA, May 23, 2019
L347)
“Chronic Kidney Disease as a Cardiovascular Risk State” Helen Dunham Cardio-Renal
Lecture and Cardiovascular Grand Rounds, Brigham and Women’s Hospital, Boston, MA,
May 23, 2019
L348)
“Biomarkers and Assessment of Cardiac Function In Fabry Cardiomyopathy” 6th
Update on Fabry Disease: Biomarkers, Progression and Treatment Opportunities, Prague,
Czech Republic, May 26-28, 2019
L349)
“Contrast-Induced Acute Kidney Injury” 37th Vicenza Course on AKI &CRRT, Vicenza,
Italy, May, 28-30 2019
L350)
“Cardiac Biomarkers in AKI” 37th Vicenza Course on AKI &CRRT, Vicenza, Italy, May,
28-30 2019
L351)
“Risk Mitigation in the Cardiac Catheterization Laboratory” 37th Vicenza Course on
AKI &CRRT, Vicenza, Italy, May, 28-30 2019
L352)
“Pathophysiology and Current Concepts in Classification” Clinical Practice Clinical
Science Track: Treatment of Cardiorenal Syndrome, American Heart Association
Hypertension Scientific Sessions, New Orleans, LA, Sept 8, 2019
L353)
“Cardiovascular Genetics” 44th Annual Williamsburg Conference on Heart Disease,
Williamsburg, VA, December 9, 2019
L354)
“Cardiorenal Syndromes” 17th World Congress on Insulin Resistance, Diabetes &
Cardiovascular Disease (WCIRDC), Los Angeles, CA, December 4-7, 2019
L355)
“Cardiorenal Syndromes” Internal Medicine Grand Rounds, Eastern Virginia College
of Medicine, Norfolk, VA, February 19, 2020
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L356)
"Keynote Address: Prevention of Heart and Kidney Disease” Annual Cardio Renal
Metabolic Conference, Cardiorenal Society of America, Phoenix, AZ March 6, 2020
L357)
“Cardioprotective Effects of Antidiabetic Medications: Focus on Sodium-Glucose
Transporter-2 Antagonists” Annual Cardio Renal Metabolic Conference, Cardiorenal Society
of America, Phoenix, AZ March 7, 2020
L358)
“Fabry Disease: A Unique Cardiorenal Model” Annual Cardio Renal Metabolic
Conference, Cardiorenal Society of America, Phoenix, AZ March 7, 2020
L359)
“Biomarkers in Heart and Kidney Disease: Practical Applications” Annual Cardio
Renal Metabolic Conference, Cardiorenal Society of America, Phoenix, AZ March 7, 2020
L360)
“Expert Briefing from ADA 2020 Select Sessions: Update on Heart Failure for the
Diabetologist & Cardiorenal–Metabolic Axis in Diabetes” American Diabetes Association,
June 14, 2020
L361)
“CKD, CHD and Hyperkalaemia: Clinical Outcomes, Morbidity and Mortality”
American College of Cardiology - American Society of Nephrology Masterclass September
11, 2020
L362)
“RAASi Enabling in Cardiology Practice - Traditional vs New Potassium Binders;
Potassium Binders for Treatment of Hyperkalaemia in HF” American College of Cardiology -
American Society of Nephrology Masterclass September 11, 2020
L363)
”Optimizing Transitions from Hospital to Home: Best Practices for Reducing
Readmissions in Heart Failure” Hospital Management Summit, October 3, 2020.
L364)
“Assessment and Management of Hyperkalemia in the Hospital Setting: Optimizing
Patient Outcomes” Hospital Management Summit, October 3, 2020.
L365)
“Navigating the Challenges of Cardio-Renal Syndrome” 7th Annual Kansas
Cardiovascular Symposium, October 10, 2020
L366)
”Management Considerations for Heart Failure in CKD” American Society of
Nephrology Kidney Week 2020, October 24, 2020
L367)
“Pathophysiologic Basis and Rationale for Early Ambulatory Treatment of SARS-CoV-2
(COVID-19), SciInov, November 2, 2020
L368)
“CV and Renal Benefits with new anti-diabetes medications: Potential Mechanisms”
CReDO Conferences Middle East North Africa (MENA) 2020, November 6, 2020
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L369)
“Consequences of Withholding GDMT for Heart Failure in CKD: One Step Forward,
Two Steps Back” AHA 2020 November 16, 2020
L370)
“Early Ambulatory Treatment for SARS-CoV-2 (COVID-19)” Early Outpatient
Treatment: An Essential Part of a COVID-19 Solution. US. Senate Committee on Homeland
Security and Governmental Affairs, Washington DC November 19, 2020
L371)
“Pathophysiological Basis & Rationale for Early Outpatient Treatment of SARS-CoV-2
(COVID-19) Infection” 18th Annual World Congress Insulin Resistance Diabetes &
Cardiovascular Disease, December 3, 2020
L372)
“Early Ambulatory Therapy for COVID-19 and Update on Vaccine Safety” Heritage
Foundation, Washington DC, June 23, 2021
L373)
“Pathophysiological Basis and Clinical Rationale for Early Ambulatory Treatment of
COVID-19” Question Everything Conference Lockdowns – Is Now the Time for a Better
Solution?, London, UK, July 17, 2021
L374)
“Pathophysiological Basis and Clinical Rationale for Early Ambulatory Treatment of
COVID-19 and Update on Vaccine Safety” American Academy of Anti-Aging Medicine, Ann
Arbor, MI, July 18, 2021
L375)
“Keynote: Winning the War Against Therapeutic Nihilism and the Rush to Replace
Trusted Treatments with Untested Novel Therapies” Association of American Physicians
and Surgeons, AAPS 78th Annual Meeting, Sept. 30 to Oct. 2, 2021 – Pittsburgh, PA, October
2, 2021
INTERNAL COMMITTEE POSITIONS
1) Member, Henry Ford Medical Group Hypertension Control Committee, 1998.
2) Ranking Member and Presenter, HFHS Institutional Review Board, 1998-2000.
3) Member, HFHS Teaching and Education Committee, Co-Chair of the Research
Subcommittee, 1999-2000
4) Member, HFHS Graduate Medical Education Committee, 1999-2000.
5) Member, HFHS, Internal Medicine Residency Selection Committee, 1998-2000.
6) Chair, HFHS, Cardiovascular Diseases Fellowship Program Selection Committee, 1999-2000.
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7) Co-Chair, HFHS, Information Technology and Medical Records Committee, 1999-2000.
8) Member, HFHS Department of Internal Medicine, Research Committee, 1999-2000.
9) Member, UMKC Adult Health Sciences Institutional Review Board, 2001-2002
10) Member, UMKC, Cardiovascular Diseases Fellowship Program Selection Committee, 2000-
2002
11) Member, Truman Medical Center (TMC) Information Technology Steering Committee, 2001-
2002.
12) Member, WBH Diabetes Research Center Steering Committee, 2002-2003
13) Chairperson, WBH Staff Privileges Appeals Committee, March 31, 2004
14) Chairperson, WBH Search Committee for Medical Director of Transplantation Medicine,
2005-2006
15) WBH Research Institute Board of Governors, board member, 2007-2010
16) Oakland University William Beaumont School of Medicine, Medical Student Committee
(founding) for development of Liaison Committee on Medical Education (LCME) application,
2007-2010
17) St. John Providence Health System Graduate Medical Education Steering Committee (Chair),
2010 to 2013
18) St. John Providence Health System Research Leaders Committee, Chair, 2010 to 2012; Co-
Chair 2012 to 2013
19) Ascension Michigan Research Affinity Group, Chair, 2010 to 2012; Co-Chair 2012 to 2013
20) St. John Providence Health System Executive Committee, 2011 to 2013
21) St. John Providence Health System Guidelines Committee, 2012 to 2013
22) St. John Providence Health System Presidents Council, 2012 to 2013
23) St. John Providence Health System Electronic Medical Record Meaningful Use Steering
Committee, 2013
24) BUMC Graduate Medical Education Committee, 2014 to present
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25) BUMC Internal Medicine Residency Program Clinical Competency Committee, 2014 to 2021
26) BUMC Clinical Cardiology Fellowship Program Clinical Competency Committee, 2014 to
2021
27) BUMC Founding Member, Department of Molecular Pathology and Medicine, 2016 to 2021
28) BUMC Precision Medicine Executive Committee, 2016 to 2021
29) BUMC COVID-19 Therapeutic Task Force 2020
EXTERNAL COMMITTEE POSITIONS
1) Member, AHA National Women’s Heart Disease and Stroke Campaign, Healthcare Provider
Sub-Group, Dallas, TX, 1998-1999
2) Member, AHA, Chronic Coronary Disease in the Elderly National Database Planning
Committee, Dallas, TX, 1998-2000
3) Chair, Michigan Chapter of the American College of Cardiology, Annual Mini-Board Review,
1999-2000
4) Member, Michigan Chapter of the American College of Cardiology, Annual Meeting Planning
Committee, 1999-2000
5) Member, National Kidney Disease Outcomes Quality Initiative (K/DOQI) Clinical Practice
Guidelines Committee on Chronic Kidney Disease, Andrew S. Levey, MD, Chair, 2001-2002
6) Member, K/DOQI Learning System (KLS)¥ Advisory Board, NKF, New York, NY, 2003 to
2010
7) Member, International EECP Patient Registry Working Group, 2003-2008.
8) Counselor at large, Michigan Chapter of the American College of Cardiology, 2004-2006
9) Member, Planning Committee, AHA, Prevention VIII Conference: Kidney Disease,
Hypertension, and Cardiovascular Disease, January 26-28, 2006, Orlando, FL
10) Chair, Contrast-Induced Nephropathy (CIN) Working Group Consensus Panel, (international,
multispecialty, consensus panel with published findings) 2004-2006. Published in Am J
Cardiol 2006 Vol 98(6)
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11) Workgroup Member, Kidney Disease Improving Global Outcomes (KDIGO), United States
Representative, Amsterdam, Netherlands, 2004, 2006
12) Member, Kidney Disease Improving Global Outcomes (KDIGO) Group for the development
of Clinical Practice Guidelines for the Diagnosis, Evaluation, Prevention, and Treatment of
Chronic Kidney Disease Related Mineral and Bone Disorders (CKD-MBD), Paris, France,
2007-2008
13) Board of Directors Member, Kidney Disease Improving Global Outcomes (KDIGO), United
States Representative, Brussels, Belgium, 2007-2010
14) Workgroup Member, The Sixth International Acute Dialysis Quality Initiative (ADQI)
Consensus Conference VI: Acute Kidney Injury in Cardiac Surgery, Vicenza, Italy May 27 –
28, 2007
15) Workgroup Leader, Prevention: The Seventh International Acute Dialysis Quality Initiative
(ADQI) Consensus Conference VII: Cardiorenal Syndrome, Venice, Italy, September 4-5,
2008, with publication n Nephrology, Dialysis, and Transplantation, 2010.
16) Chairman, Natriuretic Peptide Testing in Acute Coronary Syndromes Consensus Panel, with
published findings in Reviews in Cardiovascular Medicine 2010, Dallas, TX, March 2, 2010
17) Scientific Advisory Board, NKF, New York, NY, 2010 to present
18) Scientific Advisory Board, Cardiorenal Society of America, Phoenix, AZ, 2012 to present
19) Workgroup Member, “Cardiovascular Disease in CKD: What is it and what can we do about
it?” Kidney Disease Improving Global Outcomes (KDIGO), October 29-31, 2010, London,
England.
20) Chairman, “Cardio-Renal Syndromes II: from pathophysiology to therapy” Eleventh
Consensus Conference Cardio-Renal Syndromes II November 30 – December 2, 2012,
Venice, Italy.
21) Conference Co-Chair: “Kidney Disease Global Outcomes (KDIGO) Controversies Conference
on Heart Failure in Chronic Kidney Disease”, Athens, Greece, May 25-28, 2017
22) Chairman, “Cardiometabolic University”, Dallas, TX, December 3-4, 2017
23) Chair, American Heart Association Council on the Kidney in Cardiovascular Disease and
Council on Clinical Cardiology. Cardiorenal Syndrome: Classification, Pathophysiology,
Diagnosis, and Treatment Strategies: A Scientific Statement From the American Heart
Association, 2019
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24) Committee Member, American College of Cardiology, Navigating Treatment Decisions for
Patients with ASCVD and Multiple Comorbidities Committee, 2019-2020
25) Chief Medical Advisor, Truth for Health Foundation, Tucson AZ, 2021 to present
26) Advisory Board Member, TrialSite News, 2021 to present
27) National and International Advisor/Reviewer/Presenter/Contributor for 4D Molecular
Therapies, ABC News, Abbott Laboratories, AbbVie, Advanced Health Media, Aegerion,
Affymax, Akceia, Akebia, Alere North America, AMAG, Amersham, Amgen, Amylin,
AntiSeptiscope, Aralez, Ardian, Adelyx, Arra Hitech, Astellas, AstraZeneca, Astute Medical,
Atherotech, Axio, BG Medicine, Avenue Therapeutics, Aventyn, Back Bay Lifescience
Advisors, Bayer, Biocritique, Bioexpertise, Biomarin, Bionest Partners, Bioporto, Biosite,
Biostar, BioZ, Boehringer Ingelheim, Braintree Laboratories, Broeker, Bristol Myer Squibb,
Cardiokine, Cardiorentis, Chapman and Priest, Charles River Associates, Chelsea
Therapeutics, Chiesi USA, ClearView Healthcare Partners, Clinipace, Complexa, Connected
Research and Consulting, CorMedix, Cornerstone Therapeutics, Corvidia, Covance, Critical
Diagnostics, Cromsource, Crossover Technologies, Chrysalis BioTherapeutics, Cytopheryx,
Cytel, DaVita, Daws, DeMatteo Monness, Diadexus, Daiichi Sankyo, Decision Resources, ECG
Healthcare, Edwards Life Sciences, Elsevier, Espirion, F. Hoffmann-La Roche Ltd, Fast
Biomedical, Fish and Richardson, LLC, Fisher Scientific, FlowMedica Inc, Frictionless Digital,
Fresenius Medical Care, General Electric, Genzyme, Gerson Lehrman, Gilead, GVI Clinical
Development Solutions, Health Law Partners, Healthspan DX, HealthSTAR Communications,
Hershey, Hikari, Hogan Lovells, Hudson Global, ICON, Huff, Powell, and Bailey, LLC, IMC
Press, Imidex, Impact Education, Instrumentation Laboratories, Intercept Pharmaceuticals,
Intrinsic Life Sciences, Ischemix Technologies, Janssen, Jannsen, Johnson and Johnson,
Jordan, KAI Research, Keryx, Ketchum, Inc, Knowledge Point 360, Kowa, Eli Lilly, LabCorp,
Lewis Brisbois, Liberty Dialysis, Ligand, Lipocine, Litchfield Cavo, Luitpold Pharmaceuticals,
Lundbeck, Maxaccess Managed Markets, MannKind, MEDACorp, MedEd Group, Medevera,
Medical Exchange International, Medical Package, Medicines Company, Medicure Pharma,
Inc., MedReviews, Medscape, Medtronic, Merck, Meridian 361 International Law Group,
Meso Scale Diagnostics, Miller Tanner Associates, Mitsubishi, Nanomix, Nanosphere, Nabi
Biopharmaceuticals, Navigant, NephroGenix, Neumedicines, Noorik GmbH, Norman,
Hanson, and Detroy, LLC, Novartis, NovoNordisk, NxStage, Ortho Clinical Diagnostics,
Osprey, Otsuka, Overcome, P-value Communications, Parexel, Pharmapprove, Pfizer,
Phoenix Holdings, Physicians World, PLC Medical, Praetego, PriMed, Progenabiome, Quidel
Corporation, Qualidigm, Quintiles, Reata, Reliant Pharmaceuticals, Renew Research,
Relypsa, Repros Therapeutics, Roche Diagnostics, Rock Creek, Saferox, Saghmos
Therapeutics, Salix, Sanfit, Sankyo, Sanofi, Sarepta Therapeutics, Scarritt Group, Sentinel
Investment, Sloan Law Firm, Sphingotec, Spectracell, St. Jude Medical, Strataca Systems,
Statprobe, Sunshine Heart, Synageva, Takeda, Tasly, TheHill, Thrasos, TrialSiteNews, Trinity,
Triptych Health Partners, US Medical Management, Vasomedical, Verrow, Vindico, Visiting
Physicians Association, Vitalmetrix, Vivus, Watermark, WebMD, ZS Pharma, Inc.
App000336
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 338 of 633 PageID 1064
Exhibit (
App000337
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 339 of 633 PageID 1065
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 339 of 633 PageID 1065
1
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF TEXAS
PUBLIC HEALTH AND MEDICAL
PROFESSIONALS FOR TRANSPARENCY,
Plaintiff,
-against-
FOOD AND DRUG ADMINISTRATION,
Defendant.
Civil Action No. 4:21-cv-01058-P
DECLARATION OF AARON SIRI, ESQ.
I, Aaron Siri, declare as follows:
1.
I am the Managing Partner of Siri & Glimstad LLP, counsel to Public Health and
Medical Professionals for Transparency (“PHMPT”). I am admitted to practice pro hac vice in
this action. I make this declaration in support of PHMPT’s motion for expedited production.
2.
The following is a link to a true and correct copy of a video of candidate Joe Biden
stating, “[y]ou’ve got to make all of it [the vaccine data] available to other experts across the nation
so they can look and see, so there’s a consensus this is a safe vaccine” available at https://www.c-
span.org/video/?c4988427/user-clip-jul-28-2020.
3.
The following is a link to a true and correct copy of a video of Joe Biden stating, “I
get asked the question, if . . . President [Trump] announced tomorrow we have a vaccine, would
you take it? Only if it was completely transparent and other experts in the country could look at
it. Only if we knew all of what went into it” available at https://www.facebook.com/ABCNews
Politics/videos/902987476894155/ (at 24:10).
App000338
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 340 of 633 PageID 1066
2
4.
The following is a link to a true and correct copy of a video of Joe Biden stating
that we need “total transparency so scientists outside the government know exactly what Is being
approved” available at https://abcnews.go.com/Politics/video/biden-trust-vaccine-proven-safe-
scientists-73058501.
5.
Exhibit 1, attached hereto, is a true and correct copy of a document on the FDA’s
website titled “Detail of Full-Time Equivalents” available at https://www.fda.gov/media/132
813/download.
6.
Exhibit 2, attached hereto, is a true and correct copy of a page on the White House
website titled “Remarks by President Biden at Virtual Global COVID-19 Summit” available at
https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/09/22/remarks-by-president-
biden-at-virtual-global-covid-19-summit/.
7.
Exhibit 3, attached hereto, is a true and correct copy of an article titled “Wait what?
FDA wants 55 years to process FOIA request over vaccine data” available at https://www.reuters.
com/legal/government/wait-what-fda-wants-55-years-process-foia-request-over-vaccine-data-
2021-11-18/.
8.
Exhibit 4, attached hereto, is a true and correct copy of a letter from members of
the United States Senate to The Honorable Dr. Stephen Hahn dated September 14, 2020, available
at https://www.warren.senate.gov/imo/media/doc/2020.09.14%20Letter%20to%20FDA%20re%
20transparency%20in%20vaccine%20review%20process_.pdf.
9.
Exhibit 5, attached hereto, is a true and correct copy of a press release titled “Rep.
Ralph Norman Introduces Legislation to Expedite FDA Compliance with FOIA Requests for
Vaccine Approval Data” available at https://norman.house.gov/news/documentsingle.aspx?Docu
mentID=1087.
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 341 of 633 PageID 1067
3
10.
Exhibit 6, attached hereto, is a true and correct screenshot of a tweet by Senator
Ted Cruz, available at https://twitter.com/tedcruz/status/1461523687333666817.
11.
Exhibit 7, attached hereto, is a true and correct copy of a press release titled “Pfizer
and BioNTech Announce an Agreement with U.S. Government for Up To 600 Million Doses of
mRNA-Based vaccine Candidate Against SARS-CoV-2” available at https://www.pfizer.com/
news/press-release/press-release-detail/pfizer-and-biontech-announce-agreement-us-government-
600.
12.
Exhibit 8, attached hereto, is a true and correct copy of a press release titled “Biden
Administration purchases additional doses of COVID-19 vaccines from Pfizer and Moderna”
available at https://www.hhs.gov/about/news/2021/02/11/biden-administration-purchases-addit
ional-doses-covid-19-vaccines-from-pfizer-and-moderna.html.
13.
Exhibit 9, attached hereto, is a true and correct copy of an article that appears on
the Pharmacy Today website titled “U.S. buys 200 million COVID-19 vaccines from Pfizer and
BioNTech at about $24 a dose” available at https://www.pharmacytoday.org/drugs/drugs-2021-
07-27-story2.
14.
Exhibit 10, attached hereto, is a true and correct copy of a page on the U.S.
Department of Defense’s website titled “Contracts For Aug. 2, 2021” available at https://www.def
ense.gov/News/Contracts/Contract/Article/2716710/.
15.
Exhibit 11, attached hereto, is a true and correct copy of an article titled "U.S.
Purchases Additional 50 Million Pediatric Doses Of Covid-19 Vaccine, Pfizer Says" available at
https://www.forbes.com/sites/roberthart/2021/10/28/us-purchases-additional-50-million-pediatric
-doses-of-covid-19-vaccine-pfizer-says/?sh=292ea8c72e62.
App000340
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 342 of 633 PageID 1068
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 342 of 633 PageID 1068
4
16.
Exhibit 12, attached hereto, is a true and correct copy of a page on the U.S.
Department of Defense’s website titled “Contracts For Nov. 22, 2021” available at https://www.de
fense.gov/News/Contracts/Contract/Article/2851450/.
17.
Exhibit 13, attached hereto, is a true and correct copy of a page on the Centers for
Disease Control and Prevention’s website titled “Novel Coronavirus (COVID-19)” available at
https://www.cdc.gov/budget/fact-sheets/covid-19/index.html.
18.
Exhibit 14, attached hereto, is a true and correct copy of a page on The White House
website titled "FACT SHEET: Biden Administration Announces Historic $10 Billion Investment
to Expand Access to COVID-19 Vaccines and Build Vaccine Confidence In Hardest-Hit and
Highest-Risk Communities" available at https://www.whitehouse.gov/briefing-room/statements-
releases/2021/03/25/fact-sheet-biden-administration-announces-historic-10-billion-investment-
to-expand-access-to-covid-19-vaccines-and-build-vaccine-confidence-in-hardest-hit-and-highest-
risk-communities/.
19.
Exhibit 15, attached hereto, is a true and correct copy of an article titled "White
House announces new funds for COVID-19 testing and vaccination amid delta surge" available at
https://thehill.com/policy/healthcare/564335-white-house-announces-new-funds-for-covid-19-
testing-and-vaccination-amid.
20.
Exhibit 16, attached hereto, is a true and correct copy of an email from Courtney
D. Enlow dated December 1, 2021.
21.
Exhibit 17, attached hereto, is a true and correct screenshot of data from the Centers
for Disease Control and Prevention’s COVID Data Tracker, available at https://covid.cdc.gov/
covid-data-tracker/#vaccinations_vacc-total-admin-rate-total.
App000341
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5
22.
Exhibit 18, attached hereto, is a true and correct copy of an article titled “States
with High Vaccination Rates Can Still Experience COVID-19 Surges – Here’s Why” available at
https://www.healthline.com/health-news/states-with-high-vaccination-rates-can-still-experience-
covid-19-surges-heres-why.
23.
Exhibit 19, attached hereto, is a true and correct copy of a Media Statement titled
“Statement from CDC Director Rochelle P. Walensky, MD, MPH on Today's MMWR” available
at https://www.cdc.gov/media/releases/2021/s0730-mmwr-covid-19.html.
24.
Exhibit 20, attached hereto, is a true and correct copy of an article titled “The new
Omicron COVID variant Is a stark reminder that we are still In the depths of the pandemic”
available at https://fortune.com/2021/11/26/omicron-south-africa-covid-variant-vaccine-resistant-
pandemic/.
25.
Exhibit 21, attached hereto, is a true and correct copy of an article titled “Rising
Covid-19
Breakthrough
Cases
Hinder
Efforts
to
Control
Virus”
available
at
https://www.wsj.com/articles/rising-covid-19-breakthrough-cases-hinder-efforts-to-control-
virus-11636191003.
26.
Exhibit 22, attached hereto, is a true and correct copy of a page on the Centers for
Disease Control and Prevention’s website titled “COVID-19 Vaccine Booster Shots” available at
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html.
27.
Exhibit 23, attached hereto, is a true and correct copy of a page on Pfizer's website
titled “Transparency In Clinical Trials” available at https://cdn.pfizer.com/pfizercom/Clinical-
Trial-Transparency-Policy-Paper-FINAL-2019.pdf.
28.
Exhibit 24, attached hereto, is a true and correct copy of an article titled
“Transparency of COVID-19 vaccine trials: decisions without data” available at
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 344 of 633 PageID 1070
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6
https://archive.hshsl.umaryland.edu/bitstream/handle/10713/16360/bmjebm-2021-111735.full.
pdf?sequence=1&isAllowed=y.
29.
Exhibit 25, attached hereto, is a true and correct copy of an FDA News Release
titled “FDA Approves First COVID-19 Vaccine” dated August 23, 2021, available at
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine.
30.
Exhibit 26, attached hereto, is a true and correct copy of a Citizen Petition dated
June 1, 2021, available at https://www.regulations.gov/document/FDA-2021-P-0521-0001.
31.
Exhibit 27, attached hereto, is a true and correct copy of an article titled “Why we
petitioned the FDA to refrain from fully approving any covid-19 vaccine this year” available at
https://blogs.bmj.com/bmj/2021/06/08/why-we-petitioned-the-fda-to-refrain-from-fully-
approving-any-covid-19-vaccine-this-year/.
32.
Exhibit 28, attached hereto, is a true and correct copy of an article titled “Did the
FDA
understaff
its
review
of
the
Pfizer/BioNTech
vaccine?”
available
at
https://www.statnews.com/2020/12/17/did-the-fda-understaff-its-review-of-the-pfizer-biontech-
vaccine/.
33.
Exhibit 29, attached hereto, is a true and correct copy of an article titled “Does the
FDA think these data justify the first full approval of a covid-19 vaccine?” available at
https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-
approval-of-a-covid-19-vaccine/.
34.
Exhibit 30, attached hereto, is a true and correct copy of an article titled “Covid-
19: FDA set to grant full approval to Pfizer vaccine without public discussion of data” available at
https://www.bmj.com/content/374/bmj.n2086.
App000343
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 345 of 633 PageID 1071
7
35.
Exhibit 31, attached hereto, is a true and correct copy of a page on the White House
website titled “Fact Sheet: Biden Administration Announces Details of Two Major Vaccination
Policies” available at https://www.whitehouse.gov/briefing-room/statements-releases/2021/11/04/
fact-sheet-biden-administration-announces-details-of-two-major-vaccination-policies/. The full
version of the Emergency Temporary Standard issued by the Occupational Safety and Health
Administration published in the Federal Register on November 5, 2021 is available at
https://www.federalregister.gov/documents/2021/11/05/2021-23643/covid-19-vaccination-and-
testing-emergency-temporary-standard.
36.
Exhibit 32, attached hereto, is a true and correct copy of a page on the White House
website titled “Path Out of the Pandemic” available at https://www.whitehouse.gov/covidplan/.
37.
Exhibit 33, attached hereto, is a true and correct copy of a document titled
“Memorandum for Senior Pentagon Leadership Commanders of the Combatant Commands
Defense Agency and DOD Field Activity Directors” available at https://media.defense.gov/
2021/Oct/04/2002867430/-1/-1/0/MANDATORY-CORONAVIRUS-DISEASE-2019-
VACCINATION-OF-DOD-CIVILIAN-EMPLOYEES-OSD008990-21-RESP-FINAL.PDF.
38.
Exhibit 34, attached hereto, is a true and correct copy of a page on the University
of Colorado Boulder’s website titled “COVID-19 Vaccination Requirements and Process”
available at https://www.colorado.edu/covid-19-updates/covid-19-vaccination.
39.
Exhibit 35, attached hereto, is a true and correct copy of a page on sf.gov titled
“Vaccine required” available at https://sf.gov/information/vaccine-required.
40.
Exhibit 36, attached hereto, is a true and correct copy of an article titled “Dr.
Anthony Fauci: Expect ‘a flood’ of COVID-19 vaccine mandates after full FDA approval”
App000344
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 346 of 633 PageID 1072
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 346 of 633 PageID 1072
8
published
August
6,
2021,
available
at
https://www.usatoday.com/story/news/health
/2021/08/06/anthony-fauci-covid-vaccine-mandates-fda-full-approval/5513121001/.
41.
Exhibit 37, attached hereto, is a true and correct copy of the FOIA request at issue
in this case, which is dated August 27, 2021 and was submitted by PHMPT to the Food and Drug
Administration.
42.
Exhibit 38, attached hereto, is a true and correct copy of the confirmation PHMPT
received upon submitting the FOIA Request.
43.
Exhibit 39, attached hereto, is a true and correct copy of a letter dated August 31,
2021 issued by the FDA to PHMPT.
44.
Exhibit 40, attached hereto, is a true and correct copy of a letter dated September
9, 2021 issued by the FDA to PHMPT.
45.
Exhibit 41, attached hereto, is a true and correct copy of an email from Courtney
D. Enlow dated December 2, 2021.
Pursuant to 28 U.S.C. § 1746, I declare under penalty of perjury under the laws of the
United States of America that the foregoing is true and correct to the best of my knowledge.
Dated: December 7, 2021
Aaron Siri, Esq.
App000345
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 347 of 633 PageID 1073
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 347 of 633 PageID 1073
Exhibit
App000346
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 348 of 633 PageID 1074
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 348 of 633 PageID 1074
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App000347
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 349 of 633 PageID 1075
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 349 of 633 PageID 1075
Exhibit
App000348
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 350 of 633 PageID 1076
Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 350 of 633 PageID 1076
BRIEFING ROOM
Remarks by PresidentɠBiden at Virtual Global
COVID- 19ɠSummit
SEPTEMBER 22, 2021 • SPEECHES AND REMARKS
South Court Auditorium
Eisenhower Executive Office Building
11:16 A.M. EDT
THE PRESIDENT:ɠ Good morning, everyone.ɠ And thank you for joining us today.ɠ
As I said yesterday at the United Nations, nothing is more urgent than all of us working
together to defeat COVID-19.ɠ And that — that world is going to be much better prepared for
future pandemics.ɠ We have to do both.ɠ
This summit is about supercharging our efforts in three key areas: vaccinating the world by
dramatically ramping up vaccine production, donations, delivery, and administrating the
vaccine, which is a logistical — it’s a logistical challenge; addressing the oxygen crisis in many
hospitals around the world, making other treatments more accessible, and increasing the
availability of public health tools like masks and tests; and building back better so that our
global health security infrastructure is more resilient than it is today.ɠ
We’ve all suffered.ɠ The United States has lost more than 670,000 of our fellow Americans.ɠ
Worldwide, the death toll is above 4.5 million people — 4.5 million people.ɠ And this is a global
tragedy.ɠ
And we — and we’re not going to solve this crisis with half-measures or middle-of-the-road
ambitions.ɠ We need to go big.ɠ And we need to do our part: governments, the private sector,
civil society leaders, philanthropists.ɠ This is an all-hands-on-deck crisis.ɠ
And the good news is, we know how to beat this pandemic: vaccines, public health measures,
and collective action.
App000349
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Case 4:21-cv-01058-P Document 27 Filed 12/07/21 Page 351 of 633 PageID 1077
During the first eight months of my presidency, we have worked aggressively to get Americans
and the world vaccinated.ɠ As President of the United States, my first responsibility is to
protect the American people.ɠ And I am proud that we have gone from 2 million Americans
being fully vaccinated when I took office in January 20th to 182 million and counting, today, in
America.
But we also know that to beat the pandemic here, we need to beat it everywhere.ɠ And I made
and I’m keeping the promise that America will become the arsenal of vaccines as we were the
arsenal of democracy during World War Two.
We have already shipped nearly 160 million doses to 100 countries, more than every other
country has donated combined.ɠ America’s donations of a half a billion Pfizer vaccines through
COVAX that I’ve announced before the G7 Summit in June have already begun to ship.ɠ
Today, I’m announcing another historic commitment.ɠ The United States is buying another half
billion doses of Pfizer to donate to low- and middle-income countries around the world.ɠ
This is another half a billion doses that will all be shipped by this time next year.ɠ And it brings
our total commitment to — of donati- — of donated vaccines to over 1.1 billion vaccines to be
donated.
Put another way, for every one shot we’ve administered to date in America, we have now
committed to do three shots to the rest of the world.ɠ
I want to thank Pfizer and its CEO and chairman, Albert.ɠ Albert has been a good friend and has
been helpful.ɠ They’ve been and continue to be partners and a leader in this fight.
And the United States is leading the world on vaccination donations.ɠ We need — as we’re
doing that, we need other high-income countries to deliver on their own ambitious vaccine
donations and pledges.
That’s why, today, we’re launching the EU-U.S. vaccine partnership to work more closely
together and with our partners on expanding global vaccinations.
And as we do so, we should unite around the world on a few principles: that we commit to
donating, not selling — donating, not selling, doses to low- and lower-income countries, and
that the donations come with no political strings attached; and that we support COVAX as the
main distributor for sharing WHO-approved vaccines; and that we fight vaccine
disinformation and exercise transparency to build vital public trust in these lifesaving tools.
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It’s also important that we are working toward common goals and targets so that we can
measure our progress and hold ourselves and each other accountable.
Secretary of State Blinken will be convening foreign ministers later this year to check on our
collective progress.ɠ And I propose that we come together for a second high-level virtual
summit in the first quarter of 2022 to help gauge our progress and keep our efforts fully
aligned.
Another goal is dramatically boosting global and regional vaccine manufacturing capacity,
enhancing transparency so that vaccine production and distribution is predictable and
coordinated.
In fact, an important part of the reason the United States is able to make these big, historic
donations is because we’ve worked with U.S. vaccine manufacturers to accelerate the
manufacturing rate and production.ɠ And now we’re working quickly to scale up vaccine
manufacturing in other countries around the world so they can manufacture as well.
We’re working with partner nations, pharmaceutical companies, and other manufacturers to
increase their own capacity and capability to produce and manufacture safe and highly
effective vaccines in their own countries.ɠ For example, our Quad partnership with India,
Japan, and Australia is on track to help produce at least 1 billion vaccine doses in India to boost
the global supply by the end of 2022.ɠ
And we’re providing financing and helping strengthen manufacturing in South Africa and
produce more than 500 million doses of J&J in Africa, for Africa next year.ɠ
And next, we also know from experience that getting those vaccines into people’s arms may be
the hardest logistical challenge we’ve faced.ɠ That’s why we need to significantly step up our
investment in helping countries get shots in arms.ɠ
Today, the United States is also announcing that we’re providing an additional $370 million to
support administering these shots and delivery globally.ɠ And we will be providing more than
$380 million to assist in the Global Vaccine Alliance — GAVI — to further facilitate vaccine
distribution in regions in the greatest — with the greatest need.
And while vaccinating the world is the ultimate solution to COVID-19, we know that we have
to act to save lives now.ɠ That’s why the United States are providing nearly $1.4 billion to
reduce COVID-19 deaths and mitigate transmission through bulk oxygen support, expanded
testing, and strengthening healthcare systems and more.ɠ
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And we’re going to help all of us build back better by supporting the establishment of a
financial mechanism for global health security — to simply state — to prepare for the next
pandemic, because there will be a next time.ɠ We all know that.ɠ Vice President Harris will be
speaking more on this issue later today.
And finally, I want to acknowledge the leaders from the private sector, philanthropy, and civil
society who are here today.
Governments can do a lot, but we cannot do everything on our own.ɠ We’ve asked our
nongovernmental partners to take up the call for new actions that will solve the core
challenges of making vaccines available to everyone, everywhere; solving the oxygen
availability crisis; financing health security; and more.ɠ And I’m grateful — I’m grateful for their
leadership.ɠ
And let me close by — with what I made clear yesterday at the U.N.: We can do this.ɠ This is
within our capacity.ɠ We know what needs to be done.ɠ We just have to make the choice to do
it.ɠ
You know, the leaders on the screen that I see here today, I know they’ve made that choice.ɠ
And I think they know we can do this.
And I promise you, the United States will continue to lead.ɠ We’ll continue to drive historic
commitments in vaccine donations — 1.1 billion and counting — so we can defeat COVID-19
together.ɠ
And we’ll continue to invest in creating a future of true global health security for all people.ɠ
That is a big, big goal I ha- — we have — we should have.ɠ And we’re going to lead with the
power of our example.ɠ And we’re not going to stop.
But the only way to get this done is for everyone, everywhere — is for all of us to step up, which
I’m confident you will.
And now I’d like to turn this over to Ambassador Thomas-Greenfield of the United Nations.ɠ
And I want to thank everybody on the screen I can see here, without going to each one of you.
11:25ɠA.M. EDT
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