NCT06930092

RestoratIon of Myocardial Function by PeRcutaneous cOronary interVEntion in Patients With Ischemic CardioMyoPathy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

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 medical therapy (OMT) versus OMT alone on the recovery of left ventricle ejection fraction (LVEF) in patients with ischemic cardiomyopathy and multivessel coronary artery disease. The primary hypothesis is that physiology- and imaging-guided complete revascularization with PCI combined with OMT will show greater improvements in LV systolic function at 6 months after randomization compared with OMT alone. Patients with left ventricular ejection fraction (LVEF) less than 40% on echocardiography will undergo gadolinium-enhanced cardiac MRI to determine the underlying cause of cardiac dysfunction and assess the presence of viable myocardium. Among patients suspected of having ischemic cardiomyopathy, those who provide informed consent will be considered for enrollment. Eligible patients undergoing invasive coronary angiography and meeting inclusion and exclusion criteria will be randomly assigned to either: a group receiving physiology- and imaging-guided PCI in combination with optimal medical therapy, or a group receiving optimal medical therapy alone. Improvement in LVEF will be evaluated using follow-up gadolinium-enhanced cardiac MRI at 6 months. Clinical outcomes will be assessed at 6 and 12 months, and long-term outcomes will be analyzed through 36-month follow-up.

Conditions

• Ischemic Cardiomyopathy

Interventions

Type	Name	Description
PROCEDURE	Physiology-and imaging-guided PCI	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.
DRUG	Optimal medical treatment	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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-04-30
• Completion: 2029-04-30
• First posted: 2025-04-16
• Last updated: 2025-06-26

Locations

1 site across 1 country: South Korea