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

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Apr 8, 2025

Keywords

ClinConnect Summary

This clinical trial, called the RestoratIon of Myocardial Function by PeRcutaneous cOronary interVEntion, aims to find out whether a specific heart procedure, known as percutaneous coronary intervention (PCI), can help improve heart function in patients with ischemic cardiomyopathy—a condition where the heart muscle is weakened due to reduced blood flow. The study will compare the effects of this procedure, along with standard medical treatment, to medical treatment alone. Researchers hope to see if the PCI can help patients' hearts pump better.

To be eligible for this trial, participants need to be at least 19 years old and have a specific type of heart problem, indicated by a heart scan showing their heart is not pumping well (ejection fraction less than 40%). They should also have multiple narrowed arteries in the heart. However, those with certain serious conditions, like recent heart attacks or complex heart issues that make surgery difficult, won't be able to participate. If eligible, participants will receive detailed information about the study and will need to provide consent before any procedures. This study is currently not recruiting participants, so more information will be provided when it starts.

Gender

ALL

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:
• • 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