Clinical trial NCT06930092: RestoratIon of Myocardial Function by PeRcutaneous cOronary interVEntion in Patients With Ischemic CardioMyoPathy
Official title: RestoratIon of Myocardial Function by PeRcutaneous cOronary interVEntion in Patients With Ischemic CardioMyoPathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ischemic Cardiomyopathy
Keywords: percutaneous coronary intervention
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: Seoul National University Boramae Hospital
First posted: 2025-04-16
Enrollment: 158
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: LV ejection fraction from GE-MRI
timeFrame: At 6 months after randomization
Secondary outcomes:
measure: Changes in the transmural extent of myocardial infarction from GE-MRI
timeFrame: At 6 months after randomization
measure: Number of improved dysfunctional myocardial segments from GE-MRI
timeFrame: At 6 months after randomization
measure: Changes in the LV chamber size from GE MRI
timeFrame: At 6 months after randomization
measure: LV ejection fraction from echocardiography
timeFrame: At 6 months and 12 months after randomization
measure: Number of improved dysfunctional myocardial segments from echocardiography
timeFrame: At 6 months and 12 months after randomization
measure: Changes in the LV chamber size change from echocardiography
timeFrame: At 6 months and 12 months after randomization
measure: All-cause death
timeFrame: At 6 months, 12 months, and 36 months after randomization
measure: Cardiovascular death
timeFrame: At 6 months, 12 months, and 36 months after randomization
measure: Non-fatal myocardial infarction
timeFrame: At 6 months, 12 months, and 36 months after randomization
measure: Unplanned revascularization
timeFrame: At 6 months, 12 months, and 36 months after randomization
measure: Hospitalization for heart failure
timeFrame: At 6 months, 12 months, and 36 months after randomization
measure: EuroQol 5-Dimension 5-Level Questionnaire
timeFrame: At 6 months, 12 months, and 36 months after randomization
measure: Brain natriuretic peptide (BNP or NT-Pro BNP) level
timeFrame: At 6 months, 12 months, and 36 months after randomization
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Chongno-gu
Study officials:
References: