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
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.
• 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.