NIH Awards $84 Million Grant to Compare Coronary Artery Disease Management Strategies

 

August 2, 2011

Aug. 2, 2011 — New York University (NYU) Langone Medical Center received an $84 million grant from the National Heart, Lung and Blood Institute (NHLBI) to study the comparative effectiveness of two management strategies for patients with coronary artery disease (CAD). NHLBI is part of the National Institutes of Health (NIH).

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. It will enlist the collaboration of more than 150 medical centers around the United States and hundreds of sites in 33 countries worldwide.

The grant is the largest ever awarded to NYU Langone Medical Center and one of the largest ever awarded by NIH for a comparative effectiveness trial.

"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, M.D., 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 study will determine the comparative effectiveness of a routine early invasive strategy (INV) with cardiac catheterization plus revascularization and optimal medical therapy (OMT) and lifestyle changes to a conservative strategy of OMT. The latter would reserve invasive procedures for failure of the first strategy in patients with moderate to severe ischemia. The Cardiovascular Clinical Research Center at NYU will handle clinical coordination.

The trial 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., MA, clinical chief of the division of cardiology, co-director of the Clinical Translational Science Institute. "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.

In addition to Hochman serving as study chair, the ISCHEMIA leadership committee includes faculty from Vanderbilt University, Columbia University, The University of New York at Buffalo, East Carolina University, Duke University, Brigham and Women's Hospital, and staff from the NHLBI.

NIH funded more than seventy percent of the $259 million in research grants awarded to NYU Langone Medical Center in the fiscal year of 2010. The same year, baseline NIH funding grew from $126.4 million to $138.1 million – a 9 percent increase from the previous year and a five-fold rate increase compared to other medical schools around the country.

For more information: www.med.nyu.edu