An outstanding group of cardiologists and internists dedicated to research and treatment is the core of the Cardiovascular Clinical Trials Network (CCTN). This therapeutic unit, drawn from accomplished physicians in the northeast region, recruits and follows a diversity of patients in their community and hospital practices. Under the direction of J. Thomas Bigger, Jr. M.D., the CCTN represents significant expertise and academic leadership in clinical investigation and management of cardiac arrhythmias, myocardial ischemia, cardiac surgical procedures, hypertension, heart failure and thromboembolic disorders. This gathering of successful professionals provides quality research and data that is timely as well as accurate.
The majority of doctors participating in our research network have practices with a substantial number of patients. This pool of subjects from our various sites encompasses an enormous range of communities. Our patient base is a unique resource and can support even the most demanding clinical trial. Additionally, each cooperating physician has a skilled nursing staff with research experience and training.
In pre-trial preparation, Dr. Bigger and the Advisory Council set medical policy for the clinical trials, identify appropriate projects, select center sites, direct the training of investigators, and oversee recruitment. Throughout each investigative study, they monitor compliance with trial protocol and safety, and consult with investigators to meet the challenges that each trial presents. Dr. Bigger will also work closely with the Director of the Office of Clinical Trials to coordinate administrative and scientific activities.
If an adverse event occurs during the trial process, it is recorded and managed locally. Serious adverse events will, of course, result in the immediate withdrawal of the patient from treatment. If any such circumstance is reported anywhere among the network sites, the sponsor notifies all participants and the Institutional Review Board amends the consent form. The welfare of our patients remains our chief concern.
CCTN has been designed to respond quickly to sponsors with investigative studies. We support and encourage all thoughtful explorations that are of concern to practicing cardiologists and internists. Our medical team is at the forefront of clinical trial research and we are determined to pursue new discoveries in the treatment of cardiovascular disease.
AREAS OF THERAPEUTIC FOCUS CCTN
Angina pectoris/myocardial infarction
J. Thomas Bigger, M.D.Director of CCTN, Professor of Medicine and of Pharmacology, Columbia University College of Physicians and Surgeons, and the Director of the Columbia Presbyterian Center Arrhythmia Service. His internationally recognized research has ranged from basic pharmacologic studies to clinical trials on the effects of antiarrhythmic drugs and devices, especially the use of implantable defibrillators to prevent sudden cardiac death. Other research efforts have dealt with heart rate variability, syncope, and atrial fibrillation. Dr. Bigger has been a member of the sub-board on Cardiovascular Diseases of the American Board of Internal Medicine and is an active member of the Task Force of the Working Group on Arrhythmias of the European Society of Cardiology. Additionally, he has been an editorial board member of Circulation, Journal of Pharmacology & Experimental Therapeutics, Stroke, American Journal of Medicine, and the American Journal of Cardiology, as well as a contributing author to many books, and has written more than 400 articles. He is active in national organizations such as the American Heart Association, the American College of Cardiology, and the North American Society of Pacing and Electrophysiology. Dr. Bigger has also held numerous senior consulting and advisory positions with the pharmaceutical industry, the NIH, and the FDA.
Henry N. Ginsberg, M.D. Irving Professor of Medicine, Columbia University College of Physicians and Surgeons, and Director of the Irving Center for Clinical Research, Columbia Presbyterian Center of New York Presbyterian Hospital. Dr. Ginsberg is also Chief of the Division of Preventive Medicine and Nutrition in the Department of Medicine.
John Laragh, M.D. Professor of Medicine, Weill Medical College of Cornell University. His work has revolutionized the manner in which hypertension and cardiovascular disorders are perceived, analyzed and treated. Dr. Laragh was formerly the Master Professor of Medicine, the Director of the Cardiovascular Center and Chief of Cardiology at the New York Weill Cornell Center of New York Presbyterian Hospital.
Milton Packer, M.D. Dickinson Richards Professor of Medicine and Professor of Pharmacology, Columbia University College of Physicians and Surgeons. Dr. Packer is the principal investigator of numerous multi-center trials, including two NIH-sponsored studies that focus on the pathophysiology and treatment of heart failure. He is also Chief of the Division of Circulatory Physiology and Director of the Heart Failure Center at the Columbia Presbyterian Center of New York Presbyterian Hospital.
Henry M. Spotnitz, M.D. The George H. Humphreys, II, Professor of Surgery, Columbia University College of Physicians and Surgeons, is recognized nationally as a leader in cardiothoracic surgery research. Dr. Spotnitz has participated in research with implanted cardiac defibrillators and pacemaker leads, including the CABG Patch trial, the MUSTT trial, the AVID trial, CPI-sponsored trials of the Ventak P and P2 defibrillators, and a Medtronic steroid-eluting lead trial.