The NHLBI has awarded an $84 million grant to fund the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA). The trial will randomize 8,000 patients with stable ischemic heart disease and moderate to severe ischemia. Two different treatment strategies for this patient population will be compared:
- An invasive strategy, consisting of early routine cardiac catheterization followed by revascularization plus optimal medical therapy (OMT) and lifestyle changes.
- A conservative strategy of OMT and lifestyle changes in which invasive procedures will be performed only after failure of OMT.
The primary endpoint is the combination of cardiovascular death, MI, and centrally adjudicated hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. In addition, ISCHEMIA will also assess whether the invasive strategy is better able to improve angina-related quality of life.
NYU’s Judith Hochman is the study chair. The other members of the leadership committee are William Boden, Gregg Stone, Bob Harrington, Bruce Ferguson, David Williams, and David Maron.
Here is the press release from NYU:
NIH Awards $84 Million Grant to NYU Langone Medical Center and Partnering Institutions for
First-of-its-Kind Comparative Effectiveness ISCHEMIA Clinical Trial
International study of 8,000 participants to evaluate treatment options for patients with
stable ischemic heart disease
NEW YORK, August 1, 2011 – 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.
In addition to Dr. 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 nine percent increase from the previous year and a five-fold rate increase compared to other medical schools around the country.
About NYU Langone Medical Center
NYU Langone Medical Center, a world-class, patient-centered, integrated, academic medical center, is one on the nation’s premier centers for excellence in clinical care, biomedical research and medical education. Located in the heart of Manhattan, NYU Langone is composed of three hospitals – Tisch Hospital, its flagship acute care facility; the Rusk Institute of Rehabilitation Medicine, the world’s first university-affiliated facility devoted entirely to rehabilitation medicine; and the Hospital for Joint Diseases, one of only five hospitals in the nation dedicated to orthopaedics and rheumatology – plus the NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history. The medical center’s tri-fold mission to serve, teach and discover is achieved 365 days a year through the seamless integration of a culture devoted to excellence in patient care, education and research. For more information, go to http://www.NYULMC.org.