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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Randomized trial to compare clinical outcomes between revascularization versus medical treatment alone in patients with ischemic cardiomyopathy and left ventricular dysfunction.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form prior to any study related procedure. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Criteria: * 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.

Treatments Being Tested

PROCEDURE

Percutaneous coronary intervention

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)

Samsune Medical Center
Seoul, South Korea