Cost Effectiveness and Outcomes Measurement
Through primary and secondary data analysis, ECCRI investigators are able to answer important clinical and preventive medicine research questions, specifically to measure outcomes and determine the cost effectiveness of cardiovascular imaging strategies and preventive interventions.
Under the direction of Principal Investigator Leslee Shaw, PhD, the ISCHEMIA Imaging Coordinating Center (ICC) oversees the Nuclear, CMR and Echo imaging core labs (CLs) that are certifying sites and interpreting images for the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) clinical trial. ISCHEMIA is sponsored by a grant from the U.S. National Heart, Lung, and Blood Institute of the National Institutes of Health.
New York University (NYU) is the Clinical Coordinating Center. The Statistical and Data Coordinating Center is at the Duke Clinical Research Institute (DCRI). The Imaging Coordinating Center is at Emory University. In addition, there are a number of core labs (angiography, nuclear, echo, cardiac MR, CCTA, ECG) and an Economics and Quality of Life Coordinating Center at the DCRI and Mid America Heart Institute.
The ICC coordinates data collection and interpretation of stress imaging tests at enrolling sites. The ICC oversees site-core lab concordance tracking including comparative accuracy with coronary computed tomographic measurements of coronary artery disease (CAD). Additional measures to be tracked include insufficient ischemia cases, left main CAD cases, stress testing characteristics, and functional capacity.
In addition to CL oversight, the ICC coordinates and implements educational programs on achieving high quality imaging, identifing sites requiring corrective action for imaging quality, and communicating this information to the Clinical Coordinating Center (CCC) for creation and implementation of action plans. Anticipated site quality issues include repeated ischemia overestimation. The ICC works to promptly educate sites toward achieving trial standards. The ICC also collaborates with the Statistical and Data Coordinating Center (SDCC) on analyses using imaging data.
The Emory ICC initiates reports on quality including site imager certification and coordination of a detailed site survey on equipment, site imager certification status and training, site equipment, staff qualification, and status on data image transfer capabilities. Emory is also responsible for tracking site imager quality and concordance with the CL ischemia interpretation.
For more information visit the ISCHEMIA ICC website.
The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial seeks to determine the best management strategy for patients with stable ischemic heart disease (SIHD) and moderate-severe ischemia. ISCHEMIA is a prospective, multicenter, international, randomized, controlled trial that will enroll 8,000 SIHD patients with moderate-severe ischemia from approximately 400 sites.
Doctors routinely use an invasive approach in addition to medical therapy to treat SIHD; however, it is not known if this approach is better than medical therapy alone as the initial treatment of patients with SIHD.
Emory is enrolling patients for the ISCHEMIA trial at two Emory sites. ECCRI investigator, Arshed Quyyumi, MD, is the PI at Emory University Hospital, while Henry Liberman, MD, is the PI for Emory University Hospital Midtown.