For Physicians

Who to Contact

If you are a site that is interested in participating in the ISCHEMIA study, please e-mail ISCHEMIA@nyumc.org

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 is needed to determine optimal management for patients with SIHD.

For more information, see the Executive Summary and the ISCHEMIA Study Mini Slide set.

ISCHEMIA Study Design

Approximately 400 research centers worldwide will participate in ISCHEMIA enrolling 5,000-6,000 patients.

Eligible participants will be recruited following a clinically indicated stress imaging testing, but before catheterization, and randomized in a 1:1 fashion to one of two groups:

  • Invasive (INV) Management: Study participants in this group will undergo a cardiac catheterization within 30 days of randomization; if significant coronary artery disease is present, coronary revascularization will be performed. In addition, study participants in this group will receive optimal medical therapy (OMT).
  • Conservative (CON) Management: Study participants in this group will receive optimal medical therapy (OMT) alone with catheterization and possibly revascularization if the participant is not responding to therapy.

For more information, please visit clinicaltrials.gov.

Ancillary Studies

ISCHEMIA-CKD

Patients with CKD are at increased risk of death from cardiovascular causes-15 to 30 times higher than age matched patienst without CKD. However, most cardiovascular trials, including COURAGE and BARI-2D, have routinely excluded patients with CKD or included only a small proportion of these patients. There is thus paucity of data as how to best manage SIHD in patients with CKD.

The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches- Chronic Kidney Disease trial (ISCHEMIA-CKD) is an international comparative effectiveness study to determine the best way to manage stable ischemic heart disease in patients with advanced chronic kidney disease (eGFR <30 or on dialysis).

Patients with advanced CKD and ischemia on stress test are eligible for participation. The trial is designed to run seamlessly in parallel to the main ISCHEMIA trial.

For more information, please visit clinicaltrials.gov.

CIAO-ISCHEMIA

CIAO-ISCHEMIA stands for "Changes in Ischemia and Angina over One year among ISCHEMIA trial screen failures with no obstructive corornary artery disease on coronary CT angiography. 

Patients who have been enrolled in the main trial but CCTA shows no obstructive corornary disease are eligible.

ISCHEMIA Biorepository 

The ISCHEMIA Biorepository study will serve as a resource for further analysis. It is anticipated that this repository will provide a wealth of opportunities for ancillary studies and sharing of resources with other investigators.

All participants in the main ISCHEMIA trial will be given the opportunity to participate in ISCHEMIA Biorepository, local/national regulations and site availability/facilities permitting.

 

A Message from Dr. Gregg Stone