Comparing IVUS and FFR for treating artery lesions in heart attack patients
Randomized Controlled Trial of Intravascular Ultrasound Versus Fractional Flow Reserve for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute Myocardial Infarction
This study is testing whether using ultrasound or a different method to guide treatment for blocked arteries helps heart attack patients with multiple affected vessels get better results after their initial procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1400 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 2 sites (Gwangju and 1 other locations) |
| Trial ID | NCT05812963 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the clinical outcomes of two different treatment approaches for non-infarct related artery stenosis in patients experiencing acute myocardial infarction (AMI) with multivessel disease. It will evaluate the effectiveness of intravascular ultrasound (IVUS)-guided treatment versus fractional flow reserve (FFR)-guided treatment. The study will involve patients who have undergone successful primary percutaneous coronary intervention (PCI) within 12 hours of symptom onset. By analyzing the outcomes, the study seeks to determine which method provides better results for patients with significant non-infarct related artery lesions.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older who have experienced acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI).
Not a fit: Patients who do not have multivessel disease or those who are not experiencing an acute myocardial infarction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with multivessel disease and acute myocardial infarction, potentially enhancing recovery and reducing complications.
How similar studies have performed: Previous studies have indicated the potential benefits of complete revascularization in similar patient populations, suggesting that this approach may yield positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject must be at least 19 years of age * Acute ST-segment elevation myocardial infarction (STEMI) \*STEMI: ST-segment elevation ≥0.1 mV in ≥2 contiguous leads or documented newly developed left bundle-branch block * Acute non-ST-segment elevation myocardial infarction (NSTEMI) \*NSTEMI: NSTEMI is defined as a combination of criteria with mandated elevation of a cardiac biomarker, preferably high-sensitive cardiac troponin with at least one value above 99th percentile of the upper reference limit and at least one of the following: 1. Symptoms of ischemia. 2. New or presumed new significant ST-T wave changes 3. Development of pathological Q waves on electrocardiography. 4. Imaging evidence of new or presumed new loss of viable myocardium or regional wall motion abnormality. 5. Intracoronary thrombus detected on angiography. * Successful primary percutaneous coronary intervention (PCI) in \< 12 h after the onset of symptoms for STEMI patients (In case of NSTEMI, PCI should be performed within 72 hours of symptom onset) * Multivessel disease (at least one stenosis of \>50% in a non-IRA ≥2.25 mm by visual estimation) * Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. Exclusion Criteria: * Non-IRA stenosis not amenable for PCI treatment by operators' decision * Cardiogenic shock (Killip class IV) already at presentation or the completion of IRA PCI * Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, or Everolimus * Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock) * Pregnancy or breast feeding * Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment) * Other primary valvular disease with severe degree: severe mitral regurgitation, mitral stenosis, severe aortic regurgitation, or aortic stenosis * Unwillingness or inability to comply with the procedures described in this protocol.
Where this trial is running
Gwangju and 1 other locations
- Chonnam National University — Gwangju, South Korea (Not_yet_recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Joo-Yong Hahn, MD, PhD — Samsung Medical Center
- Study coordinator: Joo Myung Lee, MD, MPH, PhD
- Email: drone80@hanmail.net
- Phone: 82-2-3410-2575
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.