RestoratIon of Myocardial Function by PeRcutaneous cOronary interVEntion in Patients With Ischemic CardioMyoPathy
Seoul National University Hospital
158 participants
Aug 3, 2025
INTERVENTIONAL
Conditions
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 ischemic cardiomyopathy and multivessel coronary artery disease.
Eligibility
Inclusion Criteria4
- 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 Criteria11
- 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
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Interventions
The criteria for performing revascularization are as follows 1. Lesions with ≥50% diameter stenosis and FFR ≤ 0.80, or lesions with severe stenosis (\>90%) 2. In vessels meeting the above criteria, IVUS findings consistent with either: * Minimum lumen area (MLA) ≤ 3 mm² * 3 mm² \< MLA ≤ 4 mm² and plaque burden \>70% For all target vessels and lesions identified for intervention, optimal revascularization should be pursued. The criteria for optimal revascularization are as follows, and operators are encouraged to achieve them: 1. Post-PCI FFR \> 0.86 in all treated vessels is recommended, with a minimum threshold of post-PCI FFR \> 0.80 to achieve functional complete revascularization. 2. Post-PCI ΔFFR (defined as \[FFR at stent distal edge\] - \[FFR at stent proximal edge\]) \< 0.05 is recommended. 3. On IVUS, achieving a minimum stent area (MSA) \> 5.5 mm² and MSA/average reference lumen \> 80% is recommended.
All study participants will receive guideline-directed medical therapy. Even for patients assigned to the optimal medical therapy group, revascularization may be performed during follow-up if clinically indicated. If such a decision is made prior to the primary endpoint assessment, a gadolinium-enhanced cardiac MRI will be performed at the time of consideration to reassess myocardial viability.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06930092