Randomized Controlled Trial of Intravascular Ultrasound Versus Fractional Flow Reserve for Non-infarct Related Artery Lesions in Patients with Multivessel Disease and Acute STEMI

Not Applicable

Conditions: Diseases of the circulatory system

Registration Number: KCT0008264

Lead Sponsor: Samsung Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 1400

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.

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient-Oriented Composite Outcome (a composite of death, MI, or repeat revascularization) after PCI

Secondary Outcome Measures

Name	Time	Method
all-cause and cardiac death, any myocardial infarction with or without periprocedural myocardial infarction, any revascularization, IRA repeat revascularization, non-IRA repeat revascularization, definite stent thrombosis and stroke