The Cardiovascular Clinical Research Center was established in 2003 under the direction of Dr. Judith S. Hochman, Harold Snyder Family Professor of Cardiology. The Cardiovascular Clinical Research Center is designed to facilitate all aspects of patient-based clinical research and education. This includes coordination of multicenter trials; support of the infrastructure for clinical research trials; as well as education of faculty, fellows and junior trainees in clinical research methodology. Since its inception, the Cardiovascular Clinical Research Center has coordinated dozens of investigator initiated and multicenter cardiovascular clinical research trials at NYU Langone Medical Center and throughout the world.
The Cardiovascular Clinical Research Center Associate Director is Dr. Harmony Reynolds and Dr. Stuart Katz serves as the Director of Clinical Research Training. The Cardiovascular Clinical Research Center is also comprised of cardiology investigators, grants manager, project managers, research coordinators, and project support staff.
The Cardiovascular Clinical Research Center at NYU School of Medicine encompasses a Clinical Coordinating Center which is leading a large international randomized trial, ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches), funded by The National Heart, Lung and Blood Institute. The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease. This is a multicenter randomized controlled trial with a target enrollment of ~8000 patients with at least moderate ischemia on stress imaging, from approximately 400 sites. Patients will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those who fail OMT.
A multicenter, randomized, international study enrolling patients with stable ischemic heart disease and advanced chronic kidney disease (ISCHEMIA-CKD trial) has also been funded by NHLBI and is directed by Dr. Sripal Bangalore, director of Cath Lab Research. The Cardiovascular Clinical Research Center’s Clinical Coordinating Center will lead this trial, the largest treatment strategy trial in patients with stable ischemic heart disease and chronic kidney disease.
The Cardiovascular Clinical Research Center is involved in the conduct of other randomized clinical trials, observational cohort studies and registries of patients with ischemic heart disease, hypertension, heart failure, unstable angina, acute myocardial infarction and cardiogenic shock, as well as percutaneous treatment of valvular heart disease.
The NYU Cardiovascular Clinical Research Center has previously led two international multi-center, randomized clinical trials of a novel pharmacologic agent in cardiogenic shock. In addition, this Center served as the Clinical Coordinating Center for another large international multicenter trial, the Occluded Artery Trial (OAT), funded by The National Heart, Lung and Blood Institute under Dr. Hochman’s direction as Study Chair. This was a landmark study which involved 2201 patients and 217 centers worldwide, completed in June 2011. This study specifically looked at whether opening an occluded infarct related artery (IRA) with percutaneous coronary intervention 3 to 28 days after an acute myocardial infarction in high-risk asymptomatic patients would reduce the rate death, MI or hospitalization for class IV heart failure. This trial and the prior NHLBI Dr Hochman led, SHOCK, led to new recommendations in the ACC/AHA and ESC practice guidelines.
The CCRC maintains special expertise in heart disease in women, particularly ischemic heart disease without obstructive CAD, a longstanding interest of Drs. Reynolds and Hochman. They previously published a study showing plaque rupture or ulceration in nearly 40% of women with MI without angiographically obstructive CAD. This study was funded by a Doris Duke Charitable Foundation award to Dr. Reynolds. A multi-center follow up study including a larger sample of men and women will launch soon. In addition, patients with moderate-severe ischemia and without obstructive CAD will be evaluated using serial symptom assessment and stress imaging in the multi-center, international CIAO-ISCHEMIA study.
Drs. Reynolds and Stuart Katz are collaborating with the NYU Dysautonomia Center to investigate the role of autonomic nervous system function in tako-tsubo cardiomyopathy. This condition predominantly affects women. In addition, the CCRC offers special expertise in assessment of platelet function and the relationship between platelet function and outcomes via a laboratory directed by Dr. Jeffrey Berger and funded by NHLBI, AHA and the Doris Duke Foundation.
Recent and ongoing studies for which NYU Langone is an enrolling center include NHLBI funded trials such as CABANA, Pyridostigmine in heart failure, FREEDOM, VIRGO, BARI 2D, Reveal, TACT, TOPCAT industry trials such as CoreValve, ABSORB, RENALGUARD, COAPT, FOURIER, REDUCE-IT, MICRA, proMRI, TRILOGY, PROTECT, Tecos, STABILITY, EXCEL, EXSCEL, and EVEREST II, among others.
The CCRC also houses the cardiovascular outcomes group led by Dr. Bangalore. The cardiovascular outcomes group is involved in outcomes based clinical research in the areas of hypertension, acute coronary syndromes, stable CAD, lipid disorders, thrombosis and platelet function and heart failure with the use of local, regional, national and international registries and databases. The outcomes group provides study design and statistical analysis support to fellows and faculty.