NYU Langone Medical Center announced it has received an $84 million grant from the National Heart, Lung, and Blood Institute (NHLBI), of the National Institutes of Health (NIH), to study the comparative effectiveness of two initial management strategies for patients with coronary artery disease. The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) is a randomized controlled trial that will study 8,000 patients with stable ischemic heart disease (SIHD) and moderate to severe ischemia. The study, funded by one of the largest grants ever awarded by the NIH for a comparative effectiveness trial, will enlist the collaboration of more than 150 medical centers around the U.S. and hundreds of sites in 33 countries worldwide. The grant is the largest ever awarded to NYU Langone Medical Center.
"NYU Langone is committed to conducting leading-edge research, such as the ISCHEMIA Trial, to contribute to the body of comparative effectiveness research to equip physicians with clinical evidence to inform medical decisions," said Robert I. Grossman, MD, dean and CEO of NYU Langone Medical Center. "Leading a trial of this size and scope is an exciting opportunity to demonstrate our commitment to excellence - not only to patients, but to the medical, scientific, and health policy communities."
The trial, which will be clinically coordinated from the Cardiovascular Clinical Research Center at NYU Langone Medical Center, will determine whether a routine early invasive strategy (INV) with cardiac catheterization followed by revascularization plus optimal medical therapy (OMT) and lifestyle changes is superior to a conservative strategy of OMT, reserving invasive procedures for failure of this strategy in patients with moderate to severe ischemia. The study will also assess whether INV improves angina-related quality of life. The other clinical trial core functions of ISCHEMIA will take place at different U.S. sites. Duke Clinical Research Institute will be the statistical and data coordinating center, and it will also serve as the coordinating center for the cost economics and quality of life. Emory School of Medicine will be the ischemia imaging coordinating center.
"The medical community agrees further study is necessary to better determine the need for an invasive strategy and the value of revascularization when treating this patient population," said study chair Judith Hochman, M.D., M.A., clinical chief of the Division of Cardiology, co-director of the Clinical Translational Science Institute, and the Harold Snyder Family Professor of Cardiology of Medicine at NYU Langone Medical Center. "With the NIH grant, we have the opportunity to collaborate with other cardiology thought leaders from around the country and world who share our urgency in learning more about what therapies offer optimal outcomes for patients in the most cost effective manner."
"This multicenter, international study provides a unique research opportunity that could yield vital information to guide clinical practice and improve quality of life and overall medical care for large, diverse populations," said Susan B. Shurin, M.D., acting director of the NHLBI.
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