IVUS Versus FFR for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute MI

Recruiting now · Not applicable

Conditions studied: ST Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction

In brief

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.

Key facts

Study ID

NCT05812963

Run by

Samsung Medical Center

People needed

1400

Starts

2023-09-18

Expected to finish

2029-12-31

Last updated by the study team

2024-10-24

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Symptoms of ischemia.
• New or presumed new significant ST-T wave changes
• Development of pathological Q waves on electrocardiography.
• Imaging evidence of new or presumed new loss of viable myocardium or regional wall motion abnormality.
• 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.

You may not qualify if…

• 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 it is running

• Samsung Medical Center — Seoul, South Korea (enrolling)
• Chonnam National University — Gwangju, South Korea

Full record on ClinicalTrials.gov

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