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: Composite of cardiovascular death, myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure.
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.
Enrollment is completed. Estimated study completion date: December 2019.
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.