๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Subject must be at least 19 years of age
* Acute ST-segment elevation myocardial infarction (STEMI)
\*STEMI: ST-segment elevation โฅ0.1 mV in โฅ2 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 โฅ2.25 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.