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New treatment option for Ischemic Cardiomyopathy
Official title RestoratIon of Myocardial Function by PeRcutaneous cOronary interVEntion in Patients With Ischemic CardioMyoPathy
ClinicalTrials.gov ID: NCT06930092
What this study is testing
What is Optimal medical treatment?
Optimal medical treatment is an investigational medicine, being studied as a potential treatment for ischemic cardiomyopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join 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...
- 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)...
You likely can't join if
- people 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
See the full eligibility 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...
- 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
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Chongno-gu, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Chongno-gu, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.