None listed
Conditions
Interventions
Procedure/Surgery : After work up including coronary angiography with invasive physiologic assessment and myocardial viability test is finished, the patients who are eligible for enrollment without an
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Inclusion criteria ? Patients with stage C heart failure and left ventricular ejection fraction50% 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first event of MACE (a composite of death, MI, admission for heart failure, advanced heart failure requiring LVAD or transplantation) | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause death;Cardiac death;Any MI, defined by Forth Universal definition of MI;Spontaneous MI, defined by Forth Universal definition of MI;Procedure-related MI, defined by ARC II definition;Admission for heart failure (acute decompensated heart failure);Advanced heart failure requiring LVAD or transplantation;Incidence of Implantable cardioverter-defibrillator (ICD) or Cardiac resynchronization therapy (CRT-D) for documented ventricular tachycardia or ventricular fibrillation (secondary prevention).;Clinically-indicated unplanned revascularization;Stroke (ischemic or hemorrhagic);EQ-5D-5L (quality of life) at 6 month;SAQ (angina severity) at 6 month;Total medical cost;Left ventricular ejection fraction at 6 month – 1 year follow-up;NT-proBNP, pg/mL at 6 month – 1 year follow-up | — |
Countries
Korea, Republic of
Contacts
Public ContactJoo Myung Lee
Samsung Medical Center
Outcome results
None listed