Sheryl F Kelsey

  • Professor Emerita

Dr. Kelsey's research interests are in the coordination of multicenter clinical trials and registries primarily in cardiology, but also in diabetes, women's health, neurology, and ophthalmology. She has served as Principal Investigator for coordinating centers for a number of National Institutes of Health-sponsored multicenter clinical trials and registries. She has served on over thirty Data and Safety Monitoring Boards for the National Institutes of Health, the Veteran's Administration and industry.

  • 1978 | Ph.D. Carnegie Mellon University, Statistics
  • 1973 | M.S. Carnegie Mellon University, Statistics
  • 1967 | A.B. Mount Holyoke College, cum laude
    Major: Mathematics Minor: Chemistry
  • 1992-2008 | Design of Clinical Trials, Epidemiology 2181. Both clinical and statistical aspects of design addressed. Assignments included a critique of reports of clinical trials in the literature. Students worked in groups to design a randomized clinical trial.

Positions Held

  • 2012 - Present | Professor Emerita
  • 2008 - Present | Professor, Clinical Translational Science Institute, Secondary Appointment, School of Medicine, University of Pittsburgh
  • 1996 - 2012 | Professor (with tenure), Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh
  • 1985 - Present | Deputy Director, Director, Co-Director, Epidemiology Data Center, Graduate School of Public Health, University of Pittsburgh
  • 1977 - 1996 | Research Associate, Assistant Professor, Associate Professor, Graduate School of Public Health, University of Pittsburgh
  • 1990 - Present | Data and Safety Monitoring Boards for National Institutes of Health, (NHLBI, NINDS, NIDDK, NEI, NIDA, NIMH) Veterans Administration and Industry
  • 1984 - Present | NIH Reviewer (NHLBI, NINDS, NIDDK, NEI, NCCAM)


  • 2009 | Pittsburgh Statistician of the Year
  • Elected 2001 | Fellow of the American Heart Association
  • Elected 1998 | Fellow of the American Statistical Association
  • Elected 1993 | Delta Omega: Honor Society in Public Health


Current Projects

  • Bypass Angioplasty Revascularization Investigation (BARI 2D) in Diabetic Patients, Data Coordinating Center, Principal Investigator, NHLBI Grant 1-R01 HL61744-01A1. This multicenter, two by two factorial, randomized, clinical trial tests two treatment strategies for diabetes as well as tests maximal medical therapy versus revascularization for patients with existing diabetes and heart disease. Five-year mortality is the primary outcome.
  • Women's Ischemia Syndrome (WISE) Coronary Vascular Dysfunction, Data Coordinating Center, Principal Investigator. Subcontract with Cedars Sinai Medical Center, R01 HL090957-02. This subcontract provides funding for the Epidemiology Data Center to serve as the Data Coordinating Center for the Women's Ischemia Stroke Evaluation (WISE) pathophysiology of ischemic heart disease project.
  • Cardiovascular events in Women's Ischemia Syndrome Evaluation (WISE), Data Coordinating Center, Principal Investigator, NHLBI R03 AG032631-02
  • Multi-center Randomized Clinical Trial on Wheeled Mobility for Preventing Pressure Ulcers, Co-Principal Investigator, NICHD R01 HD041490-06. RCT to determine the efficacy of pressure-reducing seat cushions in preventing sitting-acquired pressure ulcers in the elderly, long-term care population. 
  • Down Syndrome known as Pittsburgh Compound-B (PiB) Study, Data Coordinating Center, Principal Investigator, NIH/NIA. This study assesses amyloid deposition with PET PiB in functionally stable adults with Down Syndrome and examines the relationship of the findings to presence or absence of the apolipoprotein E4 allele.

Past Projects

  • Dynamic Evaluation of Percutaneous Coronary Intervention, Principal Investigator, Data Coordinating Center, Principal Investigator, NHLBI Grant HL33292
  • Myocardial Ischemia and Transfusion (MINT), Data Coordinating Center, Principal Investigator, NHLBI RC2 HL 101458-01
  • International Registry of Enhanced External Counter Pulsation (IEPR), Vasomedical, Inc. Contract Data Coordinating Center, Principal Investigator
  • Heart Failure Home Care Demonstration Project (HFHC) (Centers for Medicare and Medicaid Services (MCS), Data Coordinating Center, Principal Investigator
  • Women's Ischemia Syndrome Evaluation (WISE) NHLBI Contract 1HV68162, Coordinating Center, Principal Investigator
  • Bypass Angioplasty Revascularization Investigation (BARI), Data Coordinating Center, Co-Principal Investigator
  • Encophthalmitis Vitrectomy Study (EVS), Data Coordinating Center, Principal Investigator
  • Brain Trauma Research Center, Biostatistics Core, Principal Investigator
  • Epidemiology of Diabetic Complications
  • Epidemiology of Cardiovascular Risk Factors in Women
  • Brain Resuscitation Clinical Trials (BRCT I, II, & III)
  • NHLBI Type II Coronary Intervention Study
  • Liver Transplantation Database, Pilot Phase, Co-Principal Investigator
  • NHLBI PTCA Registry, Co-Principal Investigator
  • Aerobic Exercise Intervention in Cystic Fibrosis
  • Treatment of Pelvic Inflammatory Disease (PEACH)
Selected Publications

Petersen JW, Johnson BD, Kip KE, Anderson RD, Handberg EM, Sharaf, B, Mehta PK,Kelsey SF, Bairey Merz, CN, Pepine CJ. TIMI frame count and adverse events in women with no obstructive coronary disease: a pilot study from the NHLBI-sponsored Women's Ischemia Syndrome Evaluation (WISE). PloS One. 2014;(5):e96630. PMID: 24800739. PMCID:PMC4011756.

Smith SM, Huo T, Delia Johnson B, Bittner V, Kelsey SF, Vido Thompson D, Bairey Merz C, Pepine CJ, Cooper-Dehoff RM. Cardiovascular and mortality risk of apparent resistant hypertension in women with suspected myocardial ischemia: a report from the NHLI-sponsored WISE Study. J Am Heart Assoc. 2014;3(1):e000660 doi: 10.1161/JAHA. 113.000660. PMID: 24584740. PMCID: PMC3959684.

Bach RG, Brooks MM, Lombardero M, Genuth S, Donner TW, Garber A, Kennedy L, Monrad ES, Pop-Busui R,Kelsey SF, Frye RL, for the BARI 2D Investigators. Rosiglitazone and Outcomes for Patients With Diabetes Mellitus and Coronary Artery Disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial. Circulation. 2013 Aug 20; 128 (8):785-794. PMID: 23857320. PMCID: PMC3816149.

Bach RG, Brooks MM, Lombardero M, Genuth S, Donner TW, Garber A, Kennedy L, Monrad ES, Pop-Busui R,Kelsey SF, Frye RL. Response to letter regarding article, “Rosiglitazone and Outcomes for Patients With Diabetes Mellitus and Coronary Artery Disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial”. Circulation. 2014;129(16):e460-1. PMID: 24753557.

McClure CK, Patrick TE, Katz KD,Kelsey SF, Weiss HB. Birth Outcomes Following Self-Inflicted Poisoning During Pregnancy, California, 2000 to 2004.J Obstet Gynecol Neonatal Nurs. 2011 May;40(3):292-301. PMID:21585527; PMCID: N/A

Soran OZ, Feldman AM, Piña IL, Lamas GA,Kelsey SF, Selzer F, Pilotte J, Lave JR. Cost of Medical Services in Older Patients With Heart Failure: Those Receiving Enhanced Monitoring Using A Computer-Based Telephonic Monitoring System Compared With Those in Usual Care: The Heart Failure Home Care Trial.J Card Fail. 2010 Nov;16(11):859-66. PMID: 21055649; PMCID: N/A

Merz CN, Olson MB, McClure C, Yang YC, Symons J, Sopko G,Kelsey SF, Handberg E, Johnson BD, Cooper-DeHoff RM, Sharaf B, Rogers WJ, Pepine CJ. A Randomized Controlled Trial of Low-Dose Hormone Therapy on Myocardial Ischemia in Postmenopausal Women with no Obstructive Coronary Artery Disease: Results From The National Institutes Of Health/National Heart, Lung, and Blood Institute-Sponsored Women's Ischemia Syndrome Evaluation (WISE).Am Heart J. 2010 Jun;159(6):987.e1-7. PMID: 20569710; PMCID: PMC2918903

Venkitachalam L, Kip KE, Mulukutla SR, Selzer F, Laskey WK, Slater J, Cohen HA, Wilensky RL, Williams DO, Marroquin OC, Sutton-Tyrrell K, Bunker CH,Kelsey SF. Temporal Trends in Patient-Reported Angina at 1 Year After Percutaneous Coronary Revascularization in the Stent Era: A Report From the National Heart, Lung, and Blood Institute-Sponsored 1997-2006 Dynamic Registry.Circulation Cardiovasc Qual Outcomes 2009; 2:607-615; PMCID: PMC3014456

Frye RL, August P, Brooks MM, Hardison RM,Kelsey SF, MacGregor JM, Orchard TJ, Chaitman BR, Genuth SM, Goldberg SH, Hlatky MA, Jones TL, Molitch ME, Nesto RW, Sako EY, Sobel BE, the BARI 2D Study Group. A Randomized Trial of Therapies for Type 2 Diabetes and Coronary Artery Disease.N Engl J Med 2009;236(24):2503-15. PMCID: N/A

Hlatky MA, Boothroyd DB, Bravata DM, Boersma E, Booth J, Brooks MM, Carri? D, Clayton TC, Danchin N, Flather M, Hamm CW, Hueb WA, Kahler J,Kelsey SF, King SB, Kosinski AS, Lopes N, McDonald KM, Rodriguez A, Serruys P, Sigwart U, Stables RH, Owens DK, Pocock SJ. Coronary Artery Bypass Surgery Compared with Percutaneous Coronary Interventions for Multivessel Disease: a Collaborative Analysis of Individual Patient Data from Ten Randomized Trials.Lancet. 2009;373:1190-7. PMCID: N/A

Soran OZ, Piña IL, Lamas GA,Kelsey SF, Selzer F, Pilotte J, Lave JR, Feldman AM. A Randomized Clinical Trial of the Clinical Effects of Enhanced Heart Failure Monitoring Using a Computer-based Telephonic Monitoring System in Older Minorities and Women.J Card Fail. 2008;14(9):711-717

Marroquin OC, Selzer F, Mulukutla SR, Williams DO, Vlachos HA, Wilensky RL, Tanguay JF, Holper E, Abbott JD, Lee JS, Smith C, Anderson WD,Kelsey SF, Kip KE. A Comparison of Bare Metal and Drug-Eluting Stents for Off-Label Indications: Findings from the NHLBI Dynamic Registry.N Engl J Med. 2008;358:342-52.PMCID: PMC2761092

The Final Ten-Year Follow-up Results from the Bypass Angioplasty Revascularization Investigation (BARI) Randomized Trial - The BARI Investigators.J Am Coll Cardiol. 2007;49(15):1600-6.

Lawson WE, Silver MA, Hui JCK, Kennard ED,Kelsey SF, for the IEPR Investigators. Angina Patients with Diastolic Versus Systolic Heart Failure Demonstrated Comparable Immediate and One Year Benefit from Enhanced External Counterpulsation.J of Cardiac Failure. 2005;11(1):61-66.

Orenstein DM, Hovell MF, Mulvihill M, Keating KK, Hofstetter CR,Kelsey S, Morris K, Nixon PS. Strength Versus Aerobic Training in Children with Cystic Fibrosis: A Randomized, Controlled Trial.Chest. 2004;126:1204-1214.

Johnson DB, Shaw LJ, Buchthal SD, Bairey Merz CN, Kim HW, Scott KN, Doyle M, Olson MB, Pepine CJ, Den Hollander J, Sharaf B, Rogers WJ, Mankad S, Forder JR,Kelsey SF, Pohost GM. Prognosis in Women with Myocardial Ischemia in the Absence of Obstructive Coronary Disease: Results from the NHLBI-sponsored Women's Ischemia Syndrome Evaluation (WISE) Study.Circulation. 2004;109:2993-2999.

Kip KE, Marroquin OC, Kelley DE, Johnson BD,Kelsey SF, Shaw LJ, Rogers WJ, Reis SE. Clinical Importance of Obesity Versus the Metabolic Syndrome in Cardiovascular Risk in Women. A Report From the Women's Ischemia Syndrome Evaluation (WISE) Study.Circulation. 2004;109:706-713.

Barsness G, Feldman AM, Holmes DR, Holubkov R,Kelsey SF, Kennard ED, and the International EECP Patient Registry Investigators, ""The International EECP Patient Registry (IEPR): Design, Methods, Baseline Characteristics, and Acute Results.""Clin Cardio. 2001;24:435-442.

Buchthal SD, den Hollander JA, Bairey Merz CN, Rogers WJ, Pepine CJ, Reichek N, Reis S,Kelsey SF, Pohost GM. ""Metabolic Evidence of Myocardial Ischemia by 31P NMR Spectroscopy in Women with Chest Pain but No Significant Coronary Stenoses: Pilot Phase Results from NHLBI-sponsored WISE Study.""N Eng J Med. 2000:342;12;829-835.

Williams DO, Holubkov R, Yeh W, Bourassa MG, Al-Bassam M, Block PC, Cohen H, Cowley M, Dorros G, Faxon D, Holmes DR, Jacobs A,Kelsey SF, King SB, Myler R, Slater J, Stanek V, Vlachos HA, Detre KM, ""Percutaneous Coronary Intervention in the Current Era Compared With 1985-1986: The NHLBI Registries.""Circulation. 2000;102:2945-2951.

Kelsey, SF, ""Patients with diabetes did better with coronary bypass graft surgery than with percutaneous transluminal coronary angioplasty: Was this BARI finding real?""Am Heart J 1999;138:S387-S393.

Bairey-Merz CN,Kelsey SF, Pepine CJ, Reichek N, Reis SE, Rogers WJ, Sharaf BL, Sopko G, for the WISE Study Group, ""The Women’s Ischemia Syndrome Evaluation (WISE) Study: Protocol Design, Methodology and Feasibility Report.""J Am Coll Cardiol. 1999;33:1453-61.

Jacobs AK,Kelsey SF, Brooks MM, Faxon DP, Chaitman BR, Bittner V, Mock MB, Weiner BH, Dean L, Winston C, Drew L, Sopko G. ""A Better Outcome for Women as Compared to Men Undergoing Coronary Revascularization: A Report from the Bypass Angioplasty Revascularization Investigation (BARI).""Circulation. 1998;98:1279-1285.

Marion DW, Penrod LE,Kelsey SF, Obrist WD, Kochanek PM, Palmer AM, Wisniewski SP, DeKosky ST. ""Improved Outcome After Traumatic Brain Injury With The Use of Moderate Hypothermia.""N Eng J Med. 1997;336:540-546.

Detre K, Yeh W,Kelsey S, Williams D, Desvigne-Nickens P, Holmes Jr. D, Bourassa M, King III S, Faxon D, Kent K for the Investigators of the National Heart, Lung, and Blood Institute’s Percutaneous Transluminal Coronary Angioplasty Registry. ""Has Improvement in PTCA Intervention Affected Long-Term Prognosis? The NHLBI PTCA Registry Experience.""Circulation, 1995;91:2868-2875.

Endophthalmitis Vitrectomy Study Group. ""Results of the Endophthalmitis Vitrectomy Study: A Randomized Trial of Immediate Vitrectomy and of Intravenous Antibiotics for the Treatment of Post-Operative Bacterial Endophthalmitis.""Arch Ophthalmol.1995;113:1479-1496.

Kelsey SF, James M, Holubkov AL, Holubkov R, Cowley MJ, Detre KM, and Investigators from the NHLBI PTCA Registry. ""Results of Percutaneous Transluminal Coronary Angioplasty in Women. (From the 1985-86 National Heart, Lung and Blood Institute's Coronary Angioplasty Registry).""Circulation. 1993;87:720-727.

Nixon PA, Orenstein DM,Kelsey SF, Doershuk CF. ""The Prognostic Value of Exercise Testing in Patients with Cystic Fibrosis.""N Engl J Med. 1992;327:1785-8.

Kelsey SF for the BRCT Study Group. ""A Randomized Clinical Trial of Calcium Entry Blocker Administration to Comatose Survivors of Cardiac Arrest: Design, Methods and Patient Characteristics.""Controlled Clin Trials. 1991;12:525-545.

BRCT II Study Group. ""Randomized clinical study of calcium entry blocker (Lidoflazine) therapy in comatose survivors of cardiac arrest.""N Engl J Med, 3 1991;24:1225-31.

Kelsey, SF. ""Strategies for Statistical Analysis of Angiographic Data: Individual Lesions Versus Individual Patients."" In Workshop on the Patholobiology of the Human Atherosclerotic Plaque, Glagov S, Newman WP, Schaffer SA (eds.). Springer-Verlag, New York, NY, 1990; pp525-533.

Kelsey SF, Miller DP, Holubkov R, Lu AS, Cowley MJ, Faxon DP, Detre KM and Investigators from the NHLBI PTCA Registry: ""Results of Percutaneous Transluminal Coronary Angioplasty in Patients >65 Years of Age (From the 1985-86 National Heart, Lung and Blood Institute Coronary Angioplasty Registry.""Am J Cardiol. 1990;1033-1038.

Matthews KA, Meilahn E, Kuller LH,Kelsey SF, Caggiula AW, and Wing R. ""Menopause and Cardiovascular Risk Factors in Women.""N Engl J Med. 1989; 321 (10):641-646.