Revascularization Versus Medical Treatment in Patients With Ischemic Left Ventricular Dysfunction

Launched by SAMSUNG MEDICAL CENTER · Apr 12, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a procedure called revascularization, which helps improve blood flow to the heart, is more effective than just using medication alone for patients with a type of heart failure known as ischemic cardiomyopathy. This condition occurs when the heart’s left ventricle is not functioning well due to reduced blood flow caused by blocked arteries. The trial is currently looking for participants who are at least 19 years old, have heart failure with a left ventricular ejection fraction of less than 40%, and have significant blockages in their coronary arteries that can be treated with a specific procedure.

If you or a loved one are considering joining this trial, you will need to meet certain criteria, such as not having had a recent heart attack and being able to understand the potential risks and benefits of the treatment. Participants will receive either the revascularization procedure or medical treatment and will be monitored to see how well each approach works in improving heart function. This study aims to provide valuable information on the best ways to treat heart failure in patients with reduced blood flow to the heart.

Gender

ALL

Eligibility criteria

• 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.