Comparative Health effectiveness between Optimal Medical Therapy and routine invasive strategy treatment

Not Applicable

Completed

• Conditions: Health Condition 1: null- Cardiovascular Diseases,Coronary Disease,Coronary Artery Disease,Heart Diseases,Myocardial Ischemia

• Registration Number: CTRI/2013/03/003511
• Lead Sponsor: ew York University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-06-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 941

Inclusion Criteria

Participant is willing to give written informed consent

Age >= 21 years

At least moderate ischemia on a stress imaging test with nuclear myocardial perfusion

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

Severe valvular disease or valvular disease likely to require surgery within 5 years

Allergy to radiographic contrast that cannot be adequately pre-medicated, or any prior anaphylaxis to radiographic contrast

Planned major surgery necessitating interruption of dual antiplatelet therapy

Life expectancy less than 5 years due to non-cardiovascular comorbidity

Pregnancy (known to be pregnant; to be confirmed before CCTA and/or randomization, if applicable)

Enrolled in a competing trial that involves a non-approved cardiac drug or device

Inability to comply with the protocol

Exceeds the weight or size limits for CCTA or cardiac catheterization at the enrolling site

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first occurrence of cardiovascular death or nonfatal myocardial infarctionTimepoint: Four year follow up