Health Condition 1: null- Cardiovascular Diseases, Coronary Disease, Coronary Artery Disease, Heart Diseases, Myocardial Ischemia
Conditions
Interventions
Intervention1: Invasive Strategy (INV)
Routine invasive strategy with cardiac catheterization followed by revascularization plus optimal medical therapy.: Procedure: cardiac catheterization
Narrowed b
Sponsors
New York University School of Medicine
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first occurrence of cardiovascular death or nonfatal myocardial infarctionTimepoint: Four year follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular deathTimepoint: Four year follow up;Composite of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failureTimepoint: Four year follow up;Composite of cardiovascular death, nonfatal myocardial infarction, stroke, resuscitated cardiac arrest, hospitalization for unstable angina or heart failureTimepoint: Four year follow up;Disease specific quality of life per Seattle Angina Questionnaire (SAQ) Quality of Life ScaleTimepoint: Four year follow up;Health resource utilization, costs, and cost effectivenessTimepoint: Four year follow up;Hospitalization for heart failureTimepoint: Four year follow up;Hospitalization for unstable anginaTimepoint: Four year follow up;ngina control per Seattle Angina Questionnaire (SAQ) Angina Frequency ScaleTimepoint: Four year follow up;Nonfatal myocardial infarctionTimepoint: Four year follow up;Resuscitated cardiac arrestTimepoint: Four year follow up;StrokeTimepoint: Four year follow upv | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, France, Germany, Hungary, India, Israel, Italy, Japan, Mexico, New Zealand, Peru, Poland, Portugal, Republic of Korea, Russian Federation, Serbia, Singapore, Spain, Sweden, Thailand, United Kingdom, United States of America
Contacts
Public ContactDr Balram Bhargava
All India Institute of Medical Sciences
Outcome results
None listed