Stable Ischemic Heart Disease (SIHD)
Conditions
Interventions
Active Comparator: Invasive Strategy (INV) Routine invasive strategy with cardiac catheterization followed by revascularization plus optimal medical therapy. Procedure: cardiac catheterization Narr
cabbage"
). The surgery creates new routes around narrowed and blocked heart arteries. This allows more blood flow to the heart. Other Name: CABG Procedure: percutaneous coronary intervention Percutaneous c
Sponsors
New York University, School of Medicine
New York University School of Medicine New York University Stanford University National Heart, Lung, and Blood Institute (NHLBI) Albany Stratton VA Medical Center Cedars-Sinai Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. At least moderate ischemia on an ischemia test 2. Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits 3. Participant is willing to give written informed consent 4. Age > 21 years
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first occurrence of cardiovascular death or nonfatal myocardial infarction. [Time Frame:four year follow-up] | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite of cardiovascular death, nonfatal myocardial infarction, resuscitated cardiac arrest, or hospitalization for unstable angina or heart failure [Time Frame: mean three year follow-up] | — |
Countries
Japan,Asia(except Japan),North America,South America,Australia,Europe,Africa
Contacts
Public ContactShun Kohsaka
Keio University School of Medicine Department of Cardiology
Outcome results
None listed