Guided PCI to restore heart pumping in ischemic cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.