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

NCT06930092 | Recruiting DMC

• 2 other identifiers: H-2411-106-1590Not yet assigned
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Cardiomyopathy

Keywords

percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• LV ejection fraction from GE-MRI

  LV ejection fraction from gadolinium-enhanced MRI

  At 6 months after randomization

Secondary Outcomes (13)

• Changes in the transmural extent of myocardial infarction from GE-MRI

  At 6 months after randomization

• Number of improved dysfunctional myocardial segments from GE-MRI

  At 6 months after randomization

• Changes in the LV chamber size from GE MRI

  At 6 months after randomization

• LV ejection fraction from echocardiography

  At 6 months and 12 months after randomization

• Number of improved dysfunctional myocardial segments from echocardiography

  At 6 months and 12 months after randomization

Study Arms (2)

Physiology-and imaging-guided PCI

EXPERIMENTAL

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.

Procedure: Physiology-and imaging-guided PCI

Optimal medical treatment

ACTIVE COMPARATOR

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.

Drug: Optimal medical treatment

Interventions

Physiology-and imaging-guided PCI PROCEDURE

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.

Physiology-and imaging-guided PCI

Optimal medical treatment DRUG

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.

Optimal medical treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator
• Seoul National University Boramae Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Chongno-gu, 03080, South Korea

RECRUITING

Central Study Contacts

Doyeon Hwang, MD

CONTACT

82-10-7446-2779; cardiol.intv@gmail.com

Junpil Yun, MD

CONTACT

82-10-8001-9969; junpilyun@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: August 3, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available within 12 months of study completion.
• Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement

Locations

KR (1)