KCT0008380RecruitingUnknown
Revascularization versus Medical Treatment in Patients with Ischemic Left Ventricular dysfunctionRandomized Controlled Trial of Revascularization Versus Medical Treatment on Clinical Outcomes in Patients with Reduced Left Ventricular Function(RESTORE-PCI)
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- Samsung Medical Center
- Enrollment
- 900
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 19(Year) to o Limit (—)
- Sex
- All
Inclusion Criteria
- •1) Inclusion criteria
- •?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
- •2) 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.
Investigators
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