KCT0008264
Not yet recruiting
未知
Randomized Controlled Trial of Intravascular Ultrasound Versus Fractional Flow Reserve for Non-infarct Related Artery Lesions in Patients with Multivessel Disease and Acute STEMIIntravascular Ultrasound Versus Fractional Flow Reserve for Non-infarct Related Artery Lesions in Patients with MultivEssel Disease and Acute STEMI(FRAME-AMI 2 Trial)
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Samsung Medical Center
- Enrollment
- 1400
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
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 block1
- •?Successful primary percutaneous coronary intervention (PCI) for IRA in \<12 h after the onset of symptoms
- •?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.
Outcomes
Primary Outcomes
Not specified
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