INTERNATIONAL STUDY OF COMPARATIVE HEALTH EFFECTIVENESS WITH MEDICAL AND INVASIVE APPROACHES. ISCHEMIA.

Not Applicable

• Conditions: -I25; I25

• Registration Number: PER-012-14
• Lead Sponsor: ational Heart, Lung, and Blood Institute,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-22
• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

At least moderate ischemia on a stress imaging test with nuclear myocardial perfusion (≥10% myocardium), echo or cardiac magnetic resonance wall motion (≥3/16 segments with stress-induced severe hypokinesis or akinesis), or cardiac magnetic resonance perfusion (≥12% myocardium). Participant is willing to comply with all aspects of the protocol, including adherence to medical therapy and follow-up visits. Participant is willing to give written informed consent. Age ≥ 21 years

Exclusion Criteria

LVEF < 35% History of unprotected left main stenosis >50% on prior coronary computed tomography angiography (CCTA) or prior cardiac catheterization (if available). Finding of no obstructive CAD” (<50% stenosis in all major epicardial vessels) on prior CCTA or prior catheterization, performed within 12 months Prior known coronary anatomy unsuitable for either PCI or CABG Unacceptable level of angina despite maximal medical therapy Very dissatisfied with medical management of angina History of noncompliance with medical therapy Acute coronary syndrome within the previous 2 months PCI or CABG within the previous 12 months Stroke within the previous 6 months or intracranial hemorrhage at any time History of ventricular tachycardia requiring therapy for termination, or symptomatic sustained ventricular tachycardia NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months Non-ischemic dilated or hypertrophic cardiomyopathy End stage renal disease on dialysis or estimated glomerular filtration rate (eGFR) <30mL/min. (Please, check the 5.3 Protocol section).

Study & Design

• Study Type: Interventional
• Study Design: Not specified