Recruiting
Not applicable
IVUS Versus FFR for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute MI
Condition(s) studied
ST Elevation Myocardial InfarctionNon-ST Elevation Myocardial Infarction
Investigational drug(s) / intervention(s)
IVUS-guided PCI groupFFR-guided PCI group
IVUS-guided PCI group: In IVUS-guided PCI group, the current trial evaluates clinical outcome following IVUS-guided treatment decision for revascularization of non-IRA stenosis.
FFR-guided PCI group: In FFR-guided PCI group, FFR measurement for non-IRA stenosis (\>50% visual estimation) will be performed by continuous infusion of adenosine (140\~180 ug/kg/min) or intracoronary nicorandil (2 mg bolus) injection. The FFR ≤0.80 will be targeted for PCI. In case of non-IRA stenosis \>90%, we will judge FFR value of ≤0.80.
Study 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
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.
Primary outcome measure(s)
- Patient-Oriented Composite Outcome — 2 years after last patient enrollment
a composite of death, myocardial infarction, or repeat revascularization
Trial sites (2)
| Facility | City | Region | Status |
| Chonnam National University |
Gwangju |
South Korea |
Not Yet Recruiting |
| Samsung Medical Center |
Seoul |
South Korea |
Recruiting |
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