NCT05812963 IVUS Versus FFR for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute MI
| NCT ID | NCT05812963 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samsung Medical Center |
| Condition | ST Elevation Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,400 participants |
| Start Date | 2023-09-18 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,400 participants in total. It began in 2023-09-18 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of the study is to compare clinical outcomes between intravascular ultrasound (IVUS)-guided treatment decision versus fractional flow reserve (FFR)-guided treatment decision for non-infarct related artery stenosis in patients with acute myocardial infarction (AMI) and multivessel disease.
Eligibility 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.
Contact & Investigator
Joo-Yong Hahn, MD, PhD
PRINCIPAL INVESTIGATOR
Samsung Medical Center
Frequently Asked Questions
Who can join the NCT05812963 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying ST Elevation Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05812963 currently recruiting?
Yes, NCT05812963 is actively recruiting participants. Contact the research team at drone80@hanmail.net for enrollment information.
Where is the NCT05812963 trial being conducted?
This trial is being conducted at Gwangju, South Korea, Seoul, South Korea.
Who is sponsoring the NCT05812963 clinical trial?
NCT05812963 is sponsored by Samsung Medical Center. The principal investigator is Joo-Yong Hahn, MD, PhD at Samsung Medical Center. The trial plans to enroll 1,400 participants.