International Study of comparative health effectiveness with medical and invasive approaches

Recruiting

• Conditions: coronairy heartdisease; stable ischemic heart disease; 10082206

• Registration Number: NL-OMON41604
• Lead Sponsor: ew York University School of Medicine (Dr. Judith S. Hochman)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 85

Inclusion Criteria

Informed Consent
Ischemia
Eligible for CT

Exclusion Criteria

LVEF<35%
Not suitable for PCI or CABG
Angina complaints despite maximal medical therapy
Acute coronary syndrome in previous 2 months

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary aim of the ISCHEMIA trial is to determine whether an invasive<br /><br>strategy of routine early catheterization followed by optimal<br /><br>revascularization, in addition to OMT, will reduce the primary composite<br /><br>endpoint of cardiovascular death or nonfatal myocardial infarction in<br /><br>participants with SIHD and at least moderate ischemia over an average follow-up<br /><br>of approximately 4 years compared with an initial conservative strategy of OMT<br /><br>alone with catheterization reserved for refractory angina symptoms, acute<br /><br>coronary syndrome, acute ischemic heart failure, or resuscitated cardiac arrest</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary aims are to compare the following clinical and economic outcomes<br /><br>in participants randomized to INV or CON strategies: Angina control, Quality of<br /><br>Life, Hospitalization for unstable angina, Hospitalization for heart failure,<br /><br>stroke, costs, and cost-effectiveness</p><br>