Revascularization Versus Medical Treatment in Patients With Ischemic Left Ventricular Dysfunction
Recruiting · NCT05828719 · Interventional (participants receive a specific treatment) · Lead sponsor: Samsung Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Percutaneous coronary intervention
What this trial is about
Randomized trial to compare clinical outcomes between revascularization versus medical treatment alone in patients with ischemic cardiomyopathy and left ventricular dysfunction.
Who can take part
Age range
19 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Samsune Medical Center - Seoul, South Korea