Whom to Contact
If you are a site that was participating in the ISCHEMIA study, are currently participating in ISCHEMIA-EXTEND or would like to learn more about future studies (ISCHEMIA-HF or CABG-SHOCK) please contact ISCHEMIA@nyulangone.org for more information.
Rationale of the ISCHEMIA Study
The results of Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) and the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trials demonstrated that in patients with stable ischemic heart disease (SIHD), an initial management strategy of revascularization plus optimal medical therapy (OMT) did not reduce the risk of death or MI as compared with OMT alone. Both trials randomized patients after cardiac catheterization.
Following the evidence provided by COURAGE and BARI 2D, a clinical trial that randomizes SIHD patients at a uniformly higher risk prior to cardiac catheterization was needed to determine optimal management for patients with SIHD.
For more information, see the NIH RePORT for the ISCHEMIA trial. Also posted are the ISCHEMIA protocol versions:
- ISCHEMIA Protocol v1.0 (Jan-18-2012)
- ISCHEMIA Protocol v2.0 (Jan-6-2014)
- Protocol Addendum (Sept-22-2016)
- Updated plan for the primary analysis of patients' health status as a key secondary endpoint (Sep 2019)
ISCHEMIA Study Design
A total of 320 research centers worldwide participated in ISCHEMIA and enrolled 5,179 participants.
Eligible participants were recruited following a clinically indicated stress testing, but before catheterization, and randomized in a 1:1 fashion to one of two groups:
- Invasive (INV) Management: Study participants in this group underwent a cardiac catheterization within 30 days of randomization; if significant coronary artery disease was present, coronary revascularization was performed. In addition, study participants in this group received optimal medical therapy (OMT).
- Conservative (CON) Management: Study participants in this group received optimal medical therapy (OMT) alone with catheterization and possibly revascularization if the participant did not respond to optimal medical therapy.
For more information, please visit clinicaltrials.gov.