Thrombus Aspiration in ST- Elevation Myocardial Infarction in Scandinavia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7,243
- 试验地点
- 29
- 主要终点
- All-cause death
研究概览
简要总结
Treatment of myocardial infarction (blood clot in the arteries of the heart) has improved after introduction of 24/7 balloon angioplasty to open the blocked artery. However, the clot itself is not routinely removed but recent data in smaller trials indicate that this might improve recovery and prognosis. In this multicenter study of 5000 patients referred to Scandinavian hospitals for myocardial infarction the investigators test the hypothesis that patients randomized to treatment with thrombus aspiration (removing the blood clot by manual suction) before conventional angioplasty will have a reduced risk of death, fewer rehospitalisations, fewer new myocardial infarctions, reduced risk of heart failure, better coronary artery flow after angioplasty and greater reduction of infarct size compared to patients randomized to conventional angioplasty alone.
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
- Single (Outcomes Assessor)
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 a diagnosis of ST-segment elevation myocardial infarction
- •Correspondence between ECG findings and culprit artery pathoanatomy
- •A minimum of 50% stenosis in culprit artery by visual estimate
- •Possibility to perform thrombus aspiration
排除标准
- •Need for emergency coronary artery bypass grafting
- •Inability to provide informed consent
- •Age below 18 years
- •Previous randomization in the TASTE trial
结局指标
主要结局
All-cause death
时间窗: 30 days
Death from any cause will be registered via national registries during the first 30 days after study inclusion.
次要结局
- Time to re-hospitalization with nonfatal reinfarction, heart failure and target vessel revascularization(30 days to 10 years)
- Time to all-cause death or new myocardial infarction (first occurring) or in hospital treatment for heart failure(30 days to 10 years)
- Time to acute coronary occlusion, stent thrombosis and restenosis in treated lesions(1 year)
- Length of hospital stay(1 month)
- TIMI-flow grade(3 hours)
- All-cause death(1 year to 10 years)
研究者
Ole Frobert, MD, PhD
MD, PhD
Region Örebro County