FRactional Flow Reserve versus Angiography-Guided Strategy for Management of Non-Infarction RElated Artery Stenosis in Patients with Acute Myocardial infarctio
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0003091
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
In patients with acute MI and multivessel coronary artery disease, a strategy of selective PCI using FFR-guided decision making was superior to a strategy of routine PCI based on angiographic diameter stenosis for treatment of non-infarct related artery lesions regarding the risk of death, MI, or repeat revascularization.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 562
?Subject age 19 years or older
?At least one of the following
2-1. 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
2-2. 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 ischaemia.
2)New or presumed new significant ST-T wave changes
3)Development of pathological Q waves on ECG.
4)Imaging evidence of new or presumed new loss of viable myocardium or regional wall motion abnormality.
5)Intracoronary thrombus detected on angiography.
?Primary percutaneous coronary intervention (PCI) in < 12 h after the onset of symptoms
?Multivessel disease (at least one stenosis of >50% in a non-culprit vessel = 2.0 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.
?Severe stenosis with TIMI flow = II of the non-IRA artery
?Unprotected left main coronary artery disease (stenosis > 50% by visual estimation)
?Non-culprit stenosis not amenable for PCI treatment by operators decision)
?Chronic total occlusion in non-infarct related artery
? Cardiogenic shock (Killip class IV) already at presentation or the completion of culprit PCI
?Intolerance to Aspirin, Clopidogrel, Plasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus, Zotarolimus
?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 <1 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 or mitral stenosis, severe aortic regurgitation or aortic stenosis
?Patients with a history of Coronary Artery Bypass Graft(CABG) or Treated with Fibrinolytic Therapy
?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 a composite of any death and any myocardial infarction (MI)
- Secondary Outcome Measures
Name Time Method a composite of any death and any myocardial infarction (MI);All-cause mortality;Cardiac death;Any myocardial infarction without periprocedural myocardial infarction;Any myocardial infarction with periprocedural myocardial infarction;Culprit-vessel related repeat revascularization;Non-culprit vessel related repeat revascularization;Stent thrombosis;Stroke;Total amount of contrast use;Incidence of contrast-induced nephropathy;Seattle Angina Questionnaires;Seattle Angina Questionnaires