Aspiration Thrombectomy as an Adjunctive Therapy to Primary Angioplasty in Patients With ST Segment Elevation Myocardial Infarction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Myocardial salvage index assessed with SPECT MIBI.
研究概览
简要总结
The purpose of the study is to determine whether thrombus removal with aspiration thrombectomy for acute myocardial infarction reduces the infarct size.
详细描述
Acute myocardial infarction is caused by an abrupt occlusion of coronary vessel or severe reduction of coronary flow. It has been shown that the reperfusion therapy significantly improves the clinical outcome. Currently the optimal strategy is the primary angioplasty with stent implantation. The treatment is recommended by AHA/ACC and ESC if can be performed within 90 minutes from the first medical contact. However there is still a certain percentage of procedure failure. To further improve the outcome new techniques and devices are tested . Aspiration thrombectomy may facilitate the reperfusion by reducing thrombus burden. The aim of the study is to assess if adjunctive thrombectomy may improve clinical outcome in patients with an acute ST segment elevation myocardial infarction.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First acute myocardial infarction with ST segment elevation within 12 hours from pain onset
- •Culprit lesion in left anterior descending or right coronary artery.
- •Coronary flow assessed in TIMI scale ≤ 2
- •Presence of total coronary occlusion or angiographically visible thrombus in the culprit vessel
- •Patient signed informed consent
排除标准
- •Cardiogenic shock.
- •Culprit lesion in left circumflex coronary artery.
- •Status post coronary artery by-pass grafting
- •Previous myocardial infarction
- •Status post percutaneous coronary intervention.
结局指标
主要结局
Myocardial salvage index assessed with SPECT MIBI.
时间窗: 5-8 days
次要结局
- In hospital mortality(in hospital, before discharge)
- ST segment resolution after PCI;(90 minutes)
- CK-MB AUC(72 hours)
- Corrected TIMI frame count(immediately post PCI)