KCT0003091已完成未知
Comparison of Clinical Outcomes between Fractional Flow Reserve-guided Strategy and Angiography-guided Strategy in Treatment of Non-Infarction related Artery Stenosis in Patients with Acute Myocardial Infarction
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 562
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •?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.
排除标准
- •?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.
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