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International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)
NCT01471522 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease (SIHD). This is a multicenter randomized controlled trial with 5179 randomized participants with moderate or severe ischemia on stress testing. A blinded coronary computed tomography angiogram (CCTA) was performed in most participants with eGFR ≥60 mL/min/1.73m2 to identify and exclude participants with either significant unprotected left main disease (≥50% stenosis) or those without obstructive CAD (\<50% stenosis in all major coronary arteries). Of 8518 participants enrolled, those that had insufficient ischemia, ineligible anatomy demonstrated on CCTA or another exclusion criterion, did not go on to randomization. Eligible participants were then assigned at random to a routine invasive strategy (INV) with cardiac catheterization followed by revascularization, if feasible, plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cardiac catheterization and revascularization reserved for those who fail OMT. SPECIFIC AIMS A. Primary Aim The primary aim of the ISCHEMIA trial is to determine whether an initial invasive strategy of cardiac catheterization followed by optimal revascularization, if feasible, in addition to OMT, will reduce the primary composite endpoint of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure in participants with SIHD and moderate or severe ischemia over an average follow-up of approximately 3.5 years compared with an initial conservative strategy of OMT alone with catheterization reserved for failure of OMT. B. Secondary Aims Secondary aims are to determine whether an initial invasive strategy compared to a conservative strategy will improve: 1) the composite of CV death or MI; 2) angina symptoms and quality of life, as assessed by the Seattle Angina Questionnaire; 3) all-cause mortality
Conditions Studied
Interventions
- BEHAVIORAL Lifestyle
- PROCEDURE cardiac catheterization
- PROCEDURE coronary artery bypass graft surgery
- PROCEDURE percutaneous coronary intervention
- DRUG Medication
Study Locations (20)
California
- Cedars Sinai Medical Center — Beverly Hills
- UCSF - Fresno Community Regional Medical Center — Fresno
- Ronald Reagan UCLA Medical Center — Los Angeles
- University of California Irvine Medical Center — Orange
- Palo Alto Medical Foundation Research Institute — Palo Alto
- VA Palo Alto HealthCare System — Palo Alto
- Kaiser Permanente San Jose — San Jose
- Coastal Heart Medical Group — Santa Ana
- Stanford University School of Medicine — Stanford
- Torrance Memorial Medical Center — Torrance
Florida
- Daytona Heart Group — Daytona Beach
- Malcom Randall VAMC — Gainesville
- Mayo Clinic Florida — Jacksonville
- Cardiovascular Center of Sarasota — Sarasota
- Sarasota Memorial Hospital — Sarasota
Colorado
- South Denver Cardiology Associates, P.C. — Littleton
- Medical Center of the Rockies — Loveland
Alabama
- UAB Vascular Biology and Hypertension Program — Birmingham
Arizona
- Yuma Regional Medical Center — Yuma
Connecticut
- VA Connecticut Healthcare System — West Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,179 participants |
| Start Date | 2012-07 |
| Est. Completion | 2023-05-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01471522
The ClinicalTrials.gov registry entry for NCT01471522 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5,179 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,204 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 5 interventions — of which Lifestyle is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01471522 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01471522 about?
NCT01471522 is a clinical study titled "International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA)". The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease (SIHD). This is a multicenter randomized controlled trial with 5179 randomized participants with moderate or severe ischemia on stress testing. A blinded coronar...
What is the current status of trial NCT01471522?
This trial is currently completed. It is a NA study. The enrollment target is 5,179 participants. The study started on 2012-07. Estimated completion is 2023-05-30.
What conditions does trial NCT01471522 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Coronary Artery Disease, Heart Diseases, Coronary Disease, Myocardial Ischemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01471522?
The interventions under investigation include: Lifestyle (BEHAVIORAL), cardiac catheterization (PROCEDURE), coronary artery bypass graft surgery (PROCEDURE), percutaneous coronary intervention (PROCEDURE), Medication (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01471522?
This trial is sponsored by NYU Langone Health, which has 1,204 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01471522 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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