Revascularization Versus Medical Treatment in Patients With Ischemic Left Ventricular Dysfunction
Randomized Controlled Trial of Revascularization Versus Medical Treatment on Clinical Outcomes in Patients With Reduced Left Ventricular Function
Samsung Medical Center
900 participants
Jun 16, 2023
INTERVENTIONAL
Conditions
Summary
Randomized trial to compare clinical outcomes between revascularization versus medical treatment alone in patients with ischemic cardiomyopathy and left ventricular dysfunction.
Eligibility
Inclusion Criteria5
- Subject must be at least 19 years of age
- Patients with stage C heart failure and left ventricular ejection fraction\<40%
- Patients with significant coronary artery stenosis (diameter stenosis\>50% with proven inducible myocardial ischemia by invasive physiologic assessment)
- Coronary artery disease is amenable for percutaneous coronary intervention (PCI)
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive approach and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
Exclusion Criteria9
- Myocardial infarction by universal definition within 4 weeks of randomization
- Non-viable myocardium in myocardial viability test (cardiac magnetic resonance, dobutamine-stress echocardiography, delayed single-photon emission computerized tomography, or aneurysmal change in echocardiography)
- Target lesions not amenable for PCI by operators' decision
- Patients who need left ventricular assisted device (LVAD) or heart transplantation at the time of randomization
- Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, or Everolimus
- Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
- Pregnancy or breast feeding
- Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment)
- Unwillingness or inability to comply with the procedures described in this protocol.
Interventions
Revascularization indication 1. Diameter stenosis \>90% by visual assessment 2. Functionally significant stenosis (FFR≤0.80 or non-hyperemic pressure ratios≤0.89) 3. Chronic total occlusion with substantial ischemic territory. The below locations will be judged as having substantial ischemic territory. * Left main artery * Proximal to mid left anterior descending artery * Proximal left circumflex artery in left dominant coronary arterial system * Proximal to distal right coronary artery in right dominant coronary arterial system
Locations(1)
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NCT05828719