Aspiration Device Myocardial Infarction Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Limitation of infarct size
研究概览
简要总结
Early promising data are published focusing on the role of manual thrombus aspiration devices in patients with ST segment elevation (STEMI).
The aim of our single center randomized study is to evaluate the early and late effect of thrombus aspiration device (AD) after every stage during Primary PCI in the set-up of STEMI population.
Our hypothysis is that preforming thrombus aspiration after every stage of primary PCI may give early and late advantages compared to the standard primary PCI technique.
详细描述
ADMIT-Randomized Single Center Study with two arms:
Standard PCI versus Primary PCI, using thrombus aspiration device after ever step of the procedure.
Issues to be examined are:
- Immediate angiographic differences between the study arms. By evaluation of: TIMI FLOW GRADE,TIMI FRAME COUNT,MYOCARDIAL BLUSH GRADE. No reflow phenomenae,
- Infarc size evaluated by serum markers and non invasive parameters
- In hospital major adverse cardiac events
- Major adverse cardiac events during 30& 180 days of follow up
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with STEMI<12 from synptoms onset
- •eligble for primary PCI regardless of initial TIMI flow grade.
- •patients for rescue PCI after failed thrombolysis will also be included
排除标准
- •womwn with known pregnancy or who are lactating
- •pts with allergy to aspirin, clopidogrel or heparin
- •inability to obtain informed consent
- •known existence of life threatening diseases with a life expectency less than 6 months
结局指标
主要结局
Limitation of infarct size
Early and follow up related (MACE)-major adverse cardiac events
次要结局
- Efficacy of using aspiration device after every stage of Primary angiplasty