MedPath

International Study of Comparative Health Effectiveness with Medical and Invasive Approaches

Not Applicable
Recruiting
Conditions
Stable Ischemic Heart Disease (SIHD)
Registration Number
JPRN-UMIN000026116
Lead Sponsor
ew York University, School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
5000
Inclusion Criteria

Not provided

Exclusion Criteria

Continued 19. Pregnancy (known to be pregnant; to be confirmed before CCTA and/or randomization, if applicable). 20.Patient who, in the judgment of the patient's physician, is likely to have significant unprotected left main stenosis (Those who are able to undergo CCTA will have visual assessment of the left main coronary artery by the CCTA core lab). 21. Enrolled in a competing trial that involves a non-approved cardiac drug or device. 22. Inability to comply with the protocol. 23.Exceeds the weight or size limit for CCTA or cardiac catheterization at the site. 24. Canadian Cardiovascular Society Class III angina of recent onset, OR angina of any class with a rapidly progressive or accelerating pattern. 25. Canadian Cardiovascular Society Class IV angina, including unprovoked rest angina. 26. High risk of bleeding which would contraindicate the use of dual anti platelet therapy. 27. Cardiac transplant recipient. 28. Prior CABG, unless CABG was performed more than 12 months ago, and coronary anatomy has been demonstrated to be suitable for PCI or repeat CABG to accomplish complete revascularization of ischemic areas (CCC approval required).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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