Guided PCI to restore heart pumping in ischemic cardiomyopathy
RestoratIon of Myocardial Function by PeRcutaneous cOronary interVEntion in Patients With Ischemic CardioMyoPathy
This trial will test whether physiology- and imaging-guided PCI plus optimal medical therapy helps people with ischemic cardiomyopathy and multivessel disease improve left ventricular pumping better than medicines alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 158 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul, Chongno-gu) |
| Trial ID | NCT06930092 on ClinicalTrials.gov |
What this trial studies
This is a prospective, open-label, randomized multicenter trial comparing physiology- and imaging-guided complete revascularization with PCI plus optimal medical therapy (OMT) versus OMT alone in patients with ischemic cardiomyopathy and multivessel coronary disease. Eligible adults with left ventricular ejection fraction below 40% undergo gadolinium-enhanced cardiac MRI to confirm ischemic cause and myocardial viability before randomization. The PCI arm uses physiologic and imaging guidance to target complete revascularization, and LVEF change is measured by follow-up gadolinium-enhanced cardiac MRI at 6 months. Clinical outcomes are tracked at 6 and 12 months with extended follow-up through 36 months.
Who should consider this trial
Good fit: Adults aged 19 or older with ischemic cardiomyopathy, LVEF <40%, multivessel coronary disease and evidence of viable myocardium who can safely undergo PCI and MRI are ideal candidates.
Not a fit: Patients with large transmural scarring (>50% infarct extent in >25% of dysfunctional segments), non-ischemic cardiomyopathies, very recent myocardial infarction or recent life-threatening arrhythmias, or those unsuitable for PCI are unlikely to benefit.
Why it matters
Potential benefit: If successful, the approach could improve left ventricular ejection fraction and symptoms and reduce heart-failure–related complications for selected patients.
How similar studies have performed: Previous large revascularization trials in ischemic cardiomyopathy (for example STICH and the PCI-focused REVIVED study) have had mixed results, and physiology- and imaging‑guided complete PCI for this indication remains a relatively novel approach with limited direct evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject must be ≥ 19 years * Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. * Subject with LV ejection fraction \<40% from cardiac MRI * Subject with multivessel disease in major epicardial coronary artery disease or their major branches (vessel size of 2.5 mm or more than 2.5mm) considering coronary revascularization Exclusion Criteria: * Subjects with more than 50% transmural extent of infarction on GE-MRI in more than 25% of the dysfunctional myocardial segments * Subject with suspicious of other cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyopathy etc.) * Subject with recent myocardial infarction within 4 weeks * Subject with recent fatal arrhythmia (VT or VF) within 4 weeks * Subject with hemodynamically unstable state * Subject with complex coronary artery lesions, such as chronic total occlusions, in which complete revascularization is considered unfeasible * Subject for whom coronary artery bypass surgery is prioritized over coronary artery intervention * Subject with severe valvular heart disease requiring open heart surgery * Subject with history of coronary artery bypass surgery or valve surgery * Subject with expected life expectancy of less than 1 year * Subject considered ineligible for this study based on the investigator's discretion
Where this trial is running
Seoul, Chongno-gu
- Seoul National University Hospital — Seoul, Chongno-gu, South Korea (Recruiting)
Study contacts
- Study coordinator: Doyeon Hwang, MD
- Email: cardiol.intv@gmail.com
- Phone: 82-10-7446-2779
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.