ISCHEMIA

International Study of Comparative Health Effectiveness with Medical and Invasive Approaches

ClinicalTrials.gov: NCT01471522

Patient Population:

  • target enrollment is ~5000 patients with at least moderate ischemia on stress testing
  • 21 yrs or older

Trial Design: Randomized, parallel assignment, open label

Intervention: routine invasive strategy with cardiac catheterization followed by revascularization plus optimal medical therapy or conservative strategy of optimal medical therapy with cath and revasc reserved for those who fail optimal medical therapy

Primary Endpoint: Time to first occurrence of cardiovascular death or nonfatal myocardial infarction

Sponsors: NIH, NHLBI

Economic Substudy

Principal Investigator:

Daniel B. Mark, MD

ISCHEMIA: ECONOMIC STUDY

Overview

The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease. This is a multicenter randomized controlled trial with a target enrollment of ~5000 patients with at least moderate ischemia on stress imaging. Patients will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those who fail OMT.

The economic substudy will compare total medical costs for the two treatment groups by intention-to-treat and will estimate the incremental cost effectiveness of the invasive strategy relative to the conservative management strategy assessed as cost per life year added and cost per quality-adjusted life year added.

Trial is still enrolling.

See study website for more information.

ISCHEMIA Publications

Awaiting trial completion.

Fellows @ AHA 2013

November 19, 2013

American Heart Association Annual Scientific Sessions

Dr. Judy Hochman discusses the ISCHEMIA trial.

VIDEO