NCT05828719Recruiting
Revascularization Versus Medical Treatment in Patients With Ischemic Left Ventricular Dysfunction
Randomized Controlled Trial of Revascularization Versus Medical Treatment on Clinical Outcomes in Patients With Reduced Left Ventricular Function
Source: ClinicalTrials.gov · Last updated 14 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Randomized trial to compare clinical outcomes between revascularization versus medical treatment alone in patients with ischemic cardiomyopathy and left ventricular dysfunction.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 900 (estimated)
- First submitted
- 12 Apr 2023
- Start date
- 16 Jun 2023
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- Samsung Medical Center
- Diseases
- Heart failure
- NCT number
- NCT05828719
What you commit to
- Study type: Interventional
- Planned participants: 900
- From 16 Jun 2023 to the primary completion date, 1 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
- Patients who need left ventricular assisted device (LVAD) or heart transplantation at the time of randomization
- Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
- 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)
Other
- Target lesions not amenable for PCI by operators' decision
- Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, or Everolimus
- Pregnancy or breast feeding
- Unwillingness or inability to comply with the procedures described in this protocol.
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsune Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.