Status:
RECRUITING
RestoratIon of Myocardial Function by PeRcutaneous cOronary interVEntion in Patients With Ischemic CardioMyoPathy
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Seoul National University Bundang Hospital
Seoul National University Boramae Hospital
Conditions:
Ischemic Cardiomyopathy
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
To compare the effects of physiology- and imaging-guided PCI combined with optimal medical therapy (OMT) versus OMT alone on the recovery of left ventricular systolic function in patients with ischemi...
Detailed Description
This study is a prospective, open-label, randomized, multicenter trial to test the safety and efficacy of physiology- and imaging-guided complete revascularization with PCI combined with optimal medic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2029
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT06930092
Start Date
July 1 2025
End Date
April 30 2029
Last Update
June 26 2025
Active Locations (1)
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1
Seoul National University Hospital
Seoul, Chongno-gu, South Korea, 03080