KCT0008380
Recruiting
未知
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)
ConditionsDiseases of the circulatory system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the circulatory system
- Sponsor
- Samsung Medical Center
- Enrollment
- 900
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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