C5Research Physician Leadership
A. Michael Lincoff, MD
Director,
C5Research;
Director, Center for Clinical Research and Vice Chairman for Clinical Research of the Lerner Research Institute;
Vice Chairman for Research, Department of Cardiovascular Medicine
lincofa @ ccf.org
C5Research Associate Directors
C5Research Core Laboratory Directors
Wael A. Jaber, MD
Medical Director, Imaging Core and Nuclear (Cardiac) Core
Labs
jaberw @ ccf.org
Jean Cross, MSN, RN, CCRP
Manager, C5Research
crossj @ ccf.org
Tim Crowe, BS
Manager, Angiography, Intravascular Ultrasound and Carotid IMT Core Laboratories
crowet @ ccf.org
A. Michael Lincoff, MD, is the Director of the Cleveland Clinic Coordinating Center for Clinical Research (C5Research). He also oversees clinical research activities throughout the Cleveland Clinic as Director of the Center for Clinical Research and Vice Chairman for Clinical Research of the Lerner Research Institute. He is a Vice Chairman of the Department of Cardiovascular Medicine and an interventional cardiologist in the Heart and Vascular Institute. Dr. Lincoff’s clinical research activities focus on development of therapies to reduce acute and long-term complications of percutaneous coronary revascularization procedures, to optimize therapy for acute coronary ischemic syndromes, or reduce progression or complications of atherosclerosis. He has served as principal investigator or steering committee member of over 15 pivotal trials in ischemic heart disease, enrolling in aggregate over 50,000 patients, studying new antiplatelet or antithrombotic agents in the settings of coronary intervention, heart attack, or unstable angina. Dr. Lincoff is a Professor of Medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. He holds the Charles and Charlotte Fowler Endowed Chair for Cardiovascular Research at the Cleveland Clinic. Dr. Lincoff has authored or coauthored over 200 peer-reviewed articles. He has also written over 80 book chapters and reviews and presented more than 300 lectures at various medical meetings and courses throughout the world. Dr. Lincoff is currently a member of the Cardiovascular and Renal Drugs Advisory Committee of the United States Food and Drug Administration.
Steven Nissen, MD, is Chairman of the Department of Cardiovascular Medicine at Cleveland Clinic. He was Vice Chairman of the Department for nine years and Medical Director of C5Research, Cleveland Clinic Coordinating Center for Clinical Research, for five years. He was a pioneer in the development of intravascular ultrasound (IVUS), and his research continues to focus on this imaging technique. Specifically, he developed the methods used to employ IVUS in the assessment of the progression and regression of coronary atherosclerosis. Dr. Nissen has served as principal investigator for 6 major trials using IVUS to assess coronary disease and is currently conducting several additional atherosclerosis studies. Dr. Nissen has authored more than 300 journal articles, book chapters, and CD-ROMS and is Editor of Current Cardiology Report and Senior Consulting Editor to the Journal of the American College of Cardiology, in addition to several editorial board memberships. From March 2006 thru March 2007, Dr. Nissen served as President of the American College of Cardiology, was a member of the CardioRenal Advisory Panel of the FDA for 5 years, and Chairman in the final year of his membership. He continues to serve as an advisor to several FDA committees. Dr. Nissen was named by Time magazine as one of the 100 most influential people in the world in 2007 and named one of the Country’s 30 “most powerful forces in business and finance” by Smart Money Magazine. Dr. Nissen joined Cleveland Clinic in 1992 after receiving his medical degree from the University of Michigan School of Medicine, completing his Internal Medicine internship and residency at the University of California, Davis, and his Cardiology Fellowship at the University of Kentucky Medical Center.
Heather L. Gornik, MD, MHS, MMSc, is Associate Director for Vascular Trials of C5Research and Medical Director of the Non-Invasive Vascular Laboratory in the Cleveland Clinic Department of Cardiovascular Medicine. She also serves as an Assistant Professor of Medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. In addition to general cardiology, Dr. Gornik’s specialty interests include peripheral arterial disease, vascular ultrasonography, venous thromboembolism, Raynaud's phenomenon, and fibromuscular dysplasia. Dr. Gornik’s research interests include new technologies for non-invasive diagnosis of vascular disorders, as well as the optimal management of patients with peripheral arterial disease and deep vein thrombosis, and she is the principal investigator of several clinical trials. Dr. Gornik received research training in biostatistics at the Johns Hopkins University School of Hygiene and Public Health and clinical investigation at Harvard Medical School, Massachusetts Institute of Technology. She has co-authored articles in leading medical journals and is on the editorial board of Vascular Medicine. Dr. Gornik currently serves on the Board of Directors of the Intersocietal Commission for the Accreditation of Vascular Laboratories and the Vascular Disease Foundation. After receiving her medical degree from the University of Chicago Pritzker School of Medicine, Dr. Gornik completed residency, internship and fellowship training at Brigham & Women’s Hospital, Boston, before joining the Cleveland Clinic in 2005.
Roy K. Greenberg, MD, is Associate Director for Peripheral Vascular Trials and Medical Director of the Peripheral Vascular Core Lab of C5Research, Director of Endovascular Research, and a vascular surgeon with appointments in the Cleveland Clinic Departments of Vascular Surgery, Biomedical Engineering and Thoracic and Cardiovascular Surgery. He is also Associate Professor of Surgery at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. Dr. Greenberg’s specialty interests include aortic repair for aneurysms and dissections using open and endovascular techniques. His research interests focus on vascular imaging and endovascular device design. Dr. Greenberg holds over 20 patents and runs an engineering lab, clinical research program, and post-doctoral research fellowship. He is principal or co-investigator for several national trials, and has authored or co-authored over 100 articles in leading medical journals and 25 book chapters. In addition, he is an editor for the Journal of Endovascular Therapy, Annals of Vascular Surgery, Cardiovascular Surgery, Endovascular Today and ISMICS/Innovations. After receiving his undergraduate degree from Cornell University, and medical degree from the University of Cincinnati College of Medicine, Dr. Greenberg completed residency, internship and fellowship training at the University of Rochester-Strong Memorial Hospital, Rochester, NY, and a fellowship at University Hospital, Malmo, Sweden, before joining the Cleveland Clinic in 1999.
Wael A. Jaber, MD, is Associate Director of Cardiovascular Imaging and Medical Director of the Imaging Core and Nuclear (Cardiac) Core Labs of C5Research. Dr. Jaber received his medical degree from American University of Beirut, completed his Internal Medicine Residency, Cardiovascular Medicine Fellowship and Sub-Fellowship in Nuclear Cardiology at St. Luke’s-Roosevelt Hospital, Columbia University College of Physicians and Surgeons. Dr. Jaber completed a Fellowship in Advanced Cardiac Imaging at Cleveland Clinic and joined the staff of Cleveland Clinic in 2000. Dr. Jaber’s specialty interests include clinical cardiology, echocardiography, nuclear cardiology, and valvular heart disease. Since 2001, Dr. Jaber has taught monthly Nuclear Cardiology Conferences for cardiology fellows and teaches Nuclear Cardiology/Echocardiography reading daily to cardiology fellows and medical residents. Dr. Jaber has been the Imaging Core Lab Director on 3 clinical trials, site primary investigator on four trials, and a sub-investigator on over 20 national and international clinical trials. Dr. Jaber has co-authored over 20 articles and 100 abstracts in leading medical journals and has lectured nationally and internationally on Nuclear Cardiology and Echocardiography.
David O. Martin, MD, MPH, is Associate Director for Electrophysiology Trials of C5Research and a staff cardiologist in the Electrophysiology Section of the Cleveland Clinic Department of Cardiovascular Medicine. Dr. Martin’s specialty interests include arrhythmias, epidemiology, statistics, database management and clinical trials. Dr. Martin’s research interests include Implantation, programming, and interrogation of pacemakers and defibrillators; radiofrequency ablation of simple and complex arrhythmias (including those that require trans-septal puncture); and lead extraction using the an excimer laser system. Dr. Martin serves on the Data Safety Monitoring Board for the INTRINSIC-RV clinical trial, is the principal investigator of four national clinical trials and co-investigator of 30 clinical trials. He has authored or co-authored more than 60 articles in leading medical journals. Dr. Martin received his medical degree and a master degree in public health from the University of Alabama, Birmingham, completed residency and fellowship training at Beth Israel Hospital, Boston, and fellowships in Cardiology and Electrophysiology at Duke University Medical Center. Dr. Martin joined Cleveland Clinic in 2001.
Stephen J. Nicholls, MD, PhD, is Associate Director for Atherosclerosis Trials of C5Research. He is the Medical Director of the Intravascular Ultrasound and Angiography Core Laboratories and the Clinical Director of the Center for Cardiovascular Diagnostics and Prevention at the Cleveland Clinic. He is also Assistant Professor of Molecular Medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. Dr. Nicholls received his medical and cardiology training in Australia. His doctoral studies focused on the anti-inflammatory properties of HDL at the Heart Research Institute in Sydney, prior to moving to the Cleveland Clinic in 2004. Dr. Nicholls is a fellow of the Royal Australasian College of Physicians and American College of Cardiology and a member of the American Heart Association. He has authored more than 150 original manuscripts, meeting abstracts and book chapters. His current research interests include the functional properties of HDL, the role of inflammation and oxidative stress in atherogenesis and the development of new imaging modalities to assess factors that influence the natural history of atherosclerosis. Dr. Nicholls plays a lead role in clinical trials that employ intravascular ultrasound to investigate the impact of novel anti-atherosclerotic therapies and is the principal investigator of the SATURN study.
W. H. Wilson Tang, MD, is Associate Director for Heart Failure Trials of C5Research and a heart failure and cardiac transplantation cardiologist in the Cleveland Clinic Department of Cardiovascular Medicine. Dr. Tang is also staff in the Departments of Cell Biology, the Genomic Medicine Institute and the Transplantation Center. He serves as an Assistant Professor of Medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. Dr. Tang’s specialty interests include cardiomyopathy and heart failure, mechanical assist devices and cardiac transplantation, diabetes-related and cancer treatment-related cardiac complications. His research interests also include biomarkers, metabolic adaptations, cardio-renal interactions, and device-based monitoring in heart failure. He is a member of the steering committee for several national and international drug and device clinical trials. He has active leadership roles in the Heart Failure Society of America. Dr. Tang has co-authored more than 130 scientific publications in various aspects of heart failure and is on the editorial board of the Journal of Cardiac Failure and Heart. After receiving his medical degree from Harvard Medical School, Dr. Tang completed residency, internship and fellowship training at Stanford University Medical Center, and fellowships at Cleveland Clinic before joining the Cleveland Clinic in 2004.
Oussama M. Wazni, MD, is Associate Director for Electrophysiology Trials of C5Research, Director of Atrial Fibrillation Clinical Research and a staff cardiologist in the Electrophysiology Section of the Cleveland Clinic Department of Cardiovascular Medicine. Dr. Wazni’s research interests include cardiovascular imaging in the management of atrial fibrillation. He is the principal investigator for three national clinical trials and has authored or co-authored more than 30 articles in leading medical journals. He is Co-Editor of the Handbook of Cardiac Electrophysiology and a reviewer for the Journal of American College of Cardiology, Journal of Cardiovascular Electrophysiology and PACE Journal. Dr. Wazni received his medical degree from American University of Beirut, completed residency training at Cleveland Clinic, fellowships in Cardiology at the University of Texas, Houston, and Cleveland Clinic, and a fellowship in Electrophysiology at Cleveland Clinic. Dr. Wazni joined Cleveland Clinic in 2006.
Patrick L. Whitlow, MD, is Associate Director for Device Trials of C5Research and is Director of Interventional Cardiology in the Department of Cardiovascular Medicine. Dr. Whitlow’s specialty interests include cardiac catheterization, peripheral vascular and coronary angiography, coronary and peripheral vascular stenting, new interventional devices, percutaneous mitral valve repair and aortic valve replacement. Dr. Whitlow’s research interests are focused on new cardiovascular device trials. He has been the national principal investigator in many trials and is experienced presenting new device applications to the FDA. Current research includes studies with drug eluting stents, carotid revascularization, chronic total occlusions, percutaneous aortic valve replacement, percutaneous mitral valve repair, renal stenting, and percutaneous lower extremity revascularization. He has authored or coauthored over 30 book chapters and 170 articles in leading medical journals. After receiving his medical degree from Duke University School of Medicine, Dr. Whitlow completed residency and internship training in Internal Medicine at Dallas County Parkland Hospital and a fellowship in Cardiovascular Medicine at the University of Alabama Hospital, Birmingham. He was catheterization laboratory director at University of Alabama at Birmingham before joining the Cleveland Clinic in 1986.
Stanley Hazen, MD, PhD, is Biomarker Core Lab Director of C5Research, Section Head of Preventive Cardiology & Rehabilitation, Director for the Center for Cardiovascular Diagnostics and Prevention, and a staff physician in the Departments of Cell Biology and Cardiovascular Medicine at Cleveland Clinic. Dr. Hazen sees patients within the Preventive Cardiology Clinic, specializing in care of patients with hyperlipidemia, diabetes and hypertension, as well as within the Cardiovascular Rehabilitation program. His research interests include understanding the role of inflammation and oxidant stress in the pathogenesis of atherosclerosis and other inflammatory diseases, mechanisms of atherosclerosis, the biochemistry of leukocyte peroxidases, free radicals and reactive oxygen species and mechanisms of oxidative damage. Dr. Hazen is listed as a co-inventor on multiple patents for his work in identifying patients at increased risk for cardiovascular disease, diagnosing asthma, and treating inflammation and associated complications. He has been principal investigator on numerous NIH grants. Dr. Hazen has published over 180 peer-reviewed articles, invited reviews and book chapters in the fields of atherosclerosis, oxidation and inflammation chemistry, and cardiovascular disease. Dr. Hazen is on the editorial boards of Circulation, The Journal of Biological Chemistry and Free Radicals in Biology & Medicine.
Douglas E. Joseph, DO, RVT, is Carotid Intimal Medial Thickness Core Lab Director of C5Research and is staff in the Department of Cardiovascular Medicine Section of Vascular Medicine. He is the Outpatient Department Director and Continuing Quality Improvement Officer. Dr. Joseph's clinical duties include consultative services of hospitalized and outpatient clinic patients and interpretation of non-invasive vascular imaging. Educational activities include initiating a sclerotherapy training program in 2006; presenting lectures for grand rounds; conducting hospital teaching rounds and facilitating journal club. Some of Dr. Joseph’s interests include varicose and spider veins, venous insufficiency, and the swollen limb. Dr. Joseph's research interests include venous thrombosis, pseudoaneurysms and use of CIMT to assess pre-clinical atherosclerosis. He is principal or co-investigator on multiple clinical trials including STAMPEDE, WALK, and CRESCENDO. He has authored or coauthored several publications including a supplement on peripheral arterial disease, the diagnosis and treatment of heparin induced thrombocytopenia and a book chapter on venous thromboembolic disease. After receiving his medical degree from the Des Moines University, Dr. Joseph completed residency training in Internal Medicine at St. Vincent Mercy Medical Center, Toledo, Ohio, and a fellowship in Vascular Medicine at Cleveland Clinic before joining the faculty in 2004. He is board certified in Internal Medicine and Vascular Medicine and is a registered vascular technologist.
Venu Menon, MD, is Director of the Clinical Events Committee Core Lab of C5Research. He is a staff physician in the Cleveland Clinic Departments of Cardiovascular Medicine and Diagnostic Radiology, Director of the Coronary Intensive Care Unit and Associate Director of the Cardiology Fellowship Program. Dr. Menon’s specialty interests include acute coronary syndromes, valvular heart disease, cardiac intensive care, and echocardiography. His research interests include the conduct of randomized clinical trials with specific interest in the area of acute coronary syndromes and cardiogenic shock. He is a member of the steering, operations, and publication committees for several clinical trials and serves on the Data Safety Monitoring Board for the STAMPEDE trial. Dr. Menon has co-authored more than 40 medical and scientific journal articles and six book chapters. After receiving his medical degree from Jawaharlal Institute of Post Graduate Medical Education, Madras University, India, Dr. Menon completed residency, internship and fellowship training at St. Luke’s-Roosevelt Hospital Center, Columbia University College of Physicians & Surgeons. Before joining the Cleveland Clinic in 2005, he was Director of the Coronary Care and Chest Pain Units at the University of North Carolina in Chapel Hill.
Paul D. Bishop, MSEE, RVT is Manager of the Peripheral Vascular Core Lab (PVCL) of C5Research. He received his Master of Science degree in Electrical Engineering from the University of Akron, and began working as an electrical engineer in 2001. Since joining the Cleveland Clinic in 2005, Mr. Bishop developed and implemented clinical research imaging protocols for use in the PVCL using CT, Angiography, MRI, IVUS and duplex ultrasound imaging modalities using various software packages for endovascular device trials. He manages administrative and technical aspects of the core lab, and provides training to staff physicians, fellows and residents on 3D/4D CT imaging analysis software. Mr. Bishop also serves as a Senior Research Engineer for Vascular Surgery and has developed IVUS tissue characterization software for peripheral vessels based on spectral analysis of IVUS RF backscattered data correlated with histological slides. He also developed and implemented pre-clinical protocols and designed and built experimentation systems for vascular devices using human arterial tissue under simulated physiologic conditions. He is a co-author on seven medical and scientific abstracts.
Kelly Brezina, BSN, CCRP, received her Bachelor of Science Degree in Nursing at The Ohio State University. Her clinical experience began in the Cardiac Surgical Intensive Care Unit at The Ohio State University as an RN; in 1986 she became nurse manager of the Cardiac Cath Lab at St. Joseph’s Hospital in Atlanta, GA, and as of 1991, a Clinical Research Nurse Coordinator in the Department of Cardiovascular Medicine at Cleveland Clinic Heart and Vascular Institute. In 2008, she joined C5Research to supervise quality assurance, auditing and monitoring of C5Research clinical trials. Kelly is currently Research Regulatory and Quality Assurance Manager.
Jean Cross, MSN, RN, CCRP, received her Masters of Science Degree in Nursing at Case Western Reserve University. Her clinical experience was in the Intensive Coronary Care Units of Cleveland Clinic (RN, Instructor, Nurse Manager) and University Hospitals of Cleveland (Clinical Nurse Specialist). Since 1993 she has held positions in the Department of Cardiovascular Medicine at Cleveland Clinic managing research in Cardiac Pacing and Electrophysiology, Preventive Cardiology, the Clinical Events and ECG Core Labs and, most recently, the Project and Site Management group in C5Research. Jean is currently Manager, C5Research.
Tim Crowe, BS, is Manager of the Angiography, Intravascular Ultrasound (IVUS) and Carotid IMT Core Laboratories of C5Research. He joined Cardiovascular Medicine at the Cleveland Clinic in 1991 as part of the Angiography Core Laboratory, performing angiographic assessments of more than 5000 films for numerous clinical trials including CAVEAT, TAMI-9, EPIC, IMPACT-II and EPILOG-Stent. Following training in IVUS assessment in 1994, he applied his skills to interventional, transplant vasculopathy and progression/regression atherosclerosis studies. In 1996, he became Manager of the IVUS Core Laboratory and has subsequently coordinated the major IVUS progression/regression studies including REVERSAL, Apo-AI Milano, ASTEROID, ACTIVATE, ILLUSTRATE, PERISCOPE and STRADIVARIUS. Tim has co-authored many publications and abstracts and produced graphic and video material for use in presentations, media releases, DVDs and website training seminars. He has also presented IVUS and angiographic imaging training and information sessions to physicians, research nurses, technicians and monitors to more than 400 centers worldwide.
Marlene Goormastic, MPH, received her Masters in Public Health from the University of Michigan. A statistician by training, she has spent over 25 years as a statistical consultant at the Cleveland Clinic and is a co-author on over 140 medical and scientific articles. Since 2000 she has worked in C5Research as a manager for various groups (Clinical Data Management, Statistics, and Information Systems). Her current focus is the development of clinical trials from both a design and operations perspective.
Annitta Morehead, BA, RDCS, CCRC, FASE, received a bachelor degree in Health Technology Management from Capital University, Columbus, Ohio. A cardiac sonographer by training, she has spent over 22 years working on Cardiovascular Imaging clinical trials and initiated the Cardiovascular Imaging Core Laboratory in 1996. She is an author and coauthor in over 125 articles and abstracts and four book chapters in the field of echocardiography. She is a national and international invited speaker and has given over 100 lectures in echocardiographic related topics and has served as adjunct faculty at local ultrasound community colleges. Annitta has served in various committees for the American Society of Echocardiography (ASE) and the Society for Diagnostic Medical Sonography (SDMS). In 2006, she received the ASE's Cardiac Sonographer Distinguished Teacher Award and recently served as a member of the Board of Directors. As manager of the non-invasive cardiac Imaging Core, her current focus is to further automate the Imaging Core Lab processes to better meet or beat goals and timelines.
Narcis Pasca, RN, MBA, joined C5Research in 1999. Since 2003 he has been responsible for managing the activities of the Clinical Events Committee (CEC). He is also responsible for overseeing the activities of the Clinical Data Management (CDM) group. In these roles, he participated in multiple clinical trials, with a focus on designing and executing the endpoints of adjudication plans. Prior to joining C5Research, he worked for several years as a Registered Nurse at the Cleveland Clinic. Mr. Pasca holds a nursing degree as well as a MBA, both from Cleveland State University.
Alan Pratt , MT (ASCP), is Manager of the Biomarker Core Lab of C5Research in the Cleveland Clinic Department of Cardiovascular Medicine. He received his Bachelor of Science degree in Medical Technology from the University of Akron and is a laboratory generalist by training with previous experience as a clinical laboratory director. Since coming to Cleveland Clinic in 2005, Mr. Pratt has supervised laboratory activities for FDA and NIH clinical trials in the areas of chemistry, mass spectroscopy and genomics.
Kathy Wolski, MPH, received her Masters in Public Health from Yale University with a concentration in Epidemiology. Kathy has been involved in the design and analysis of clinical trials since 1998. She has co-authored several publications in top-tiered journals (NEJM, JAMA, and JACC) and has publications from several clinical trials (CACHET, TARGET, ACTIVATE, REPLACE-2, REVERSAL and ASTEROID). In 2007 she co-authored two widely cited meta-analysis articles on PPARs. Kathy has led the C5Research statistical team since 2006.
Terri Zito, BS, CRCP, is the Manager of Contracts and Finance for C5Research. She received her Bachelor in Science degree from the University of Akron, where she continued her education in their graduate program. Terri joined C5Research in 1999 and has extensive experience in the financial management of research grants, projects, and awards. She supervises all aspects of the contracting, budgeting, and accounting for both FDA and NIH clinical trials including expertise in financial and contractual administration for both trial coordination and site based research.