Thrombus Aspiration in Heavy Thrombus Burden Acute ST-elevation Myocardial Infarction: TSUNAMI Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 124
- 试验地点
- 6
- 主要终点
- In-hospital Major adverse cerebrovascular and cardiovascular events (MACCE)
研究概览
简要总结
Recent guidelines for the management of ST-elevation myocardial infarction (STEMI) recommend against the routine use of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI) (Class III indication). Yet, so far, there is limited data regarding its role STEMI patients with heavy thrombus burden (TB).
The aim of this trial is to evaluate the effects of manual TA and PCI in comparison to conventional PCI alone in a real-life clinical trial among heavy TB STEMI patients undergoing PPCI.
详细描述
Recent guidelines for the management of ST-elevation myocardial infarction (STEMI) recommend against the routine use of thrombus aspiration (TA) during primary percutaneous coronary intervention (PPCI) (Class III indication). Yet, so far, there is limited data regarding its role in STEMI patients with heavy thrombus burden (TB).
The aim of this trial is to evaluate the effects of manual TA and PCI in comparison to conventional PCI alone in a real-life clinical trial among heavy TB STEMI patients undergoing PPCI.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STEMI patients with heavy thrombus burden as assessed by TIMI score of 0-1 or thrombus burden classification 4-5
排除标准
- •STEMI patients with low thrombus burden (TIMI 2-3 or TB 0-3)
- •History of hypersensitivity or allergy to any of the study drugs, as well as known or suspected contraindications to the study drugs.
- •Symptomatic hypotension and/or an SBP < 100 mmHg at the time of randomization.
结局指标
主要结局
In-hospital Major adverse cerebrovascular and cardiovascular events (MACCE)
时间窗: 10 days
Incidence of any major adverse cerebrovascular and cardiovascular events which includes: death (either all-cause or cardiac), nonfatal myocardial infarction, stroke and revascularization (with optional additional specification of target vessel or lesion, i.e., if the revascularization occurred at the site of a previously identified diseased coronary vessel or atherosclerotic lesion, respectively)
Short term Major adverse cerebrovascular and cardiovascular events (MACCE)
时间窗: 6 months
Incidence of any major adverse cerebrovascular and cardiovascular events which includes: death (either all-cause or cardiac), nonfatal myocardial infarction, stroke and revascularization (with optional additional specification of target vessel or lesion, i.e., if the revascularization occurred at the site of a previously identified diseased coronary vessel or atherosclerotic lesion, respectively) in the period of 6 months after randomization.
Angiographic results
时间窗: immediately after procedure
Successful revascularization assessed by TIMI flow
次要结局
- Short term Hospitalization due to heart failure(6 months)
- Incidence of any bleeding event (Safety outcomes)(10 days)
- In-Hospital Heart failure status(10 days)