Revascularization Versus Medical Treatment in Patients With Ischemic Left Ventricular Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center
About this trial
Randomized trial to compare clinical outcomes between revascularization versus medical treatment alone in patients with ischemic cardiomyopathy and left ventricular dysfunction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Percutaneous coronary intervention
Procedure/SurgeryRevascularization 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
Treatment groups
900 Participants
are divided into 2 treatment groupsGroup A: Guideline-directed medical treatment groupNo intervention 0 interventions
Group B: Revascularization groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
major adverse cardiac events [MACE]
a composite of death, myocardial infarction (MI), admission for heart failure, or advanced heart failure requiring LVAD or transplantation
Time frame
2 years after last patient enrollmentSecondary outcomes
1
All-cause death
All-cause death
Time frame
2 years after last patient enrollment2
Cardiac death
Cardiac death
Time frame
2 years after last patient enrollment3
Any myocardial infarction
Any myocardial infarction by Forth Universal definition of MI
Time frame
2 years after last patient enrollment4
Spontaneous myocardial infarction
Spontaneous myocardial infarction by Forth Universal definition of MI
Time frame
2 years after last patient enrollmentSponsors and contacts
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Source ClinicalTrials.gov