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

Not Applicable

Not yet recruiting

• Conditions: Ischemic Cardiomyopathy
• Interventions: Procedure: Physiology-and imaging-guided PCI; Drug: Optimal medical treatment

• Registration Number: NCT06930092
• Lead Sponsor: Seoul National University Hospital

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 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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-04-08
• Study First Submitted QC: 2025-04-08
• Last Update Submitted: 2025-04-08
• Study First Posted: 2025-04-16
• Last Update Posted: 2025-04-16
• Study Start: 2025-05-01
• Primary Completion: 2028-04-30
• Study Completion: 2029-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 158

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

• Subject with more than 50% of the transmural extent of infarction from GE-MRI
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physiology-and imaging-guided PCI	Physiology-and imaging-guided PCI	The goal is to achieve functional complete revascularization of major coronary arteries and their branches with diameters ≥2.5 mm. For lesions with ≥50% diameter stenosis, fractional flow reserve (FFR) measurement is mandatory. However, for severely stenotic lesions (\>90%), revascularization may proceed at the operator's discretion without FFR assessment. In addition, intravascular ultrasound (IVUS) should be utilized during revascularization procedures and serve as an additional criterion for decision-making. All patients in the intervention group will receive optimal medical therapy identical to that provided to the optimal medical therapy group following PCI.
Optimal medical treatment	Optimal medical treatment	All study participants will receive guideline-directed medical therapy, including an angiotensin receptor-neprilysin inhibitor (ARNi) or an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), a beta-blocker (carvedilol or bisoprolol), an aldosterone antagonist, and an SGLT2 inhibitor (empagliflozin or dapagliflozin). Medications will be administered even at low doses, as tolerated based on the patient's clinical status. Antiplatelet agents and statins will be maintained throughout the study period, and ezetimibe or PCSK9 inhibitors may be added as needed. In addition, appropriate treatment will be provided for major cardiovascular risk factors such as hypertension, diabetes, and hyperlipidemia. Coexisting arrhythmias will be managed according to their respective guidelines. In the case of atrial fibrillation, active rate and rhythm control strategies will be implemented.

Primary Outcome Measures

Name	Time	Method
LV ejection fraction from GE-MRI	At 6 months after randomization	LV ejection fraction from gadolinium-enhanced MRI

Secondary Outcome Measures

Name	Time	Method
Changes in the transmural extent of myocardial infarction from GE-MRI	At 6 months after randomization	Changes in the transmural extent of myocardial infarction from GE-MRI
Number of improved dysfunctional myocardial segments from GE-MRI	At 6 months after randomization	Number of improved dysfunctional myocardial segments from GE-MRI
Changes in the LV chamber size from GE MRI	At 6 months after randomization	Changes in the LV chamber size from GE MRI
LV ejection fraction from echocardiography	At 6 months and 12 months after randomization	LV ejection fraction from echocardiography
Number of improved dysfunctional myocardial segments from echocardiography	At 6 months and 12 months after randomization	Number of improved dysfunctional myocardial segments from echocardiography
Changes in the LV chamber size change from echocardiography	At 6 months and 12 months after randomization	Changes in the LV chamber size change from echocardiography
All-cause death	At 6 months, 12 months, and 36 months after randomization	death from any cause
Cardiovascular death	At 6 months, 12 months, and 36 months after randomization	death from cardiovascular cause
Non-fatal myocardial infarction	At 6 months, 12 months, and 36 months after randomization	Non-fatal myocardial infarction
Unplanned revascularization	At 6 months, 12 months, and 36 months after randomization	Unplanned revascularization
Hospitalization for heart failure	At 6 months, 12 months, and 36 months after randomization	Hospitalization for heart failure
EuroQol 5-Dimension 5-Level Questionnaire	At 6 months, 12 months, and 36 months after randomization	EuroQol 5-Dimension 5-Level Questionnaire
Brain natriuretic peptide (BNP or NT-Pro BNP) level	At 6 months, 12 months, and 36 months after randomization	Brain natriuretic peptide (BNP or NT-Pro BNP) level

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Chongno-gu, Korea, Republic of