Phase III Study, Multivessel Percutaneous Treatment During Myocardial Infarction
试验速览
- 阶段
- 3 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- death at 30 days
研究概览
简要总结
Few reports described outcomes of complete compared with infarct related artery (IRA) only revascularization in patients with ST elevation myocardial infarction (STEMI) and multivessel coronary disease (CAD).
The purpose of this study is to determine outcome (death, myocardial infarction, target vessel failure) of 180 consecutive patients with STEMI and multivessel CAD undergoing primary angioplasty.
Before the first angioplasty patients are randomized to 2 different strategies: 1) culprit vessel angioplasty only, 2) staged revascularization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •myocardial acute infarction
- •prolonged chest pain (>20 minute) started less <12 hours before arrive in hospital
- •ST segment elevation of >1mm in >2 contiguous leads
- •new left bundle branch block
- •diameter of the coronary suitable of angioplasty >2mm
- •the patients agrees to the study protocol and provides a written consensus
- •two or more coronary suitable for angioplasty
排除标准
- •refused written consensus
- •hypersensitivity or contraindication to any of the following medications: heparin bivalirudin aspirin prasugrel stainless steel
- •history of bleeding
- •cardiogenic shock (PA < 90mmHg)
- •chronic total occlusion in the second lesion
- •TIMI Flow < II in the culprit lesion
- •recent pregnancy
- •history of intra-cerebral major hemorrhagic stroke
- •an elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first six months post enrollment life expectancy <1 year
研究组 & 干预措施
multivessel revascularization
Complete Revascularization : the Infarcted related artery was opened followed by dilatation of other significantly narrowed arteries during the same procedure
干预措施: Coronary angioplasty all lesions (Procedure)
结局指标
主要结局
death at 30 days
时间窗: 1 month
stent thrombosis
时间窗: 1 year
target vessel failure
时间窗: 1 year
re-acute myocardial infarction
时间窗: 1 month
次要结局
- bleeding(1 month)
- timi frame count(1 day)
- vascular site access complications(1 month)