Thrombus Aspiration During Percutaneous Coronary Intervention in Acute Non-ST-elevation Myocardial Infarction Study (TAPAS II)
试验速览
- 阶段
- 4 期
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Incidence of myocardial blush grade 3 after PCI
研究概览
简要总结
In this trial, the investigators will evaluate the effect of thrombus aspiration followed by stent implantation in improving myocardial blush grade in patients with acute non-ST-elevation myocardial infarction compared to conventional percutaneous coronary intervention (PCI).
详细描述
The Thrombus Aspiration during Percutaneous coronary intervention in Acute myocardial infarction Study (TAPAS) has shown that thrombus aspiration improves myocardial perfusion and clinical outcome compared to conventional primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction. Impaired myocardial perfusion due to spontaneous or angioplasty-induced embolization of atherothrombotic material also occurs in patients with Non-ST-elevation myocardial infarction (NSTEMI). The aim of this study is to determine whether thrombus aspiration before stent implantation will result in improved myocardial perfusion in patients with NSTEMI compared to conventional PCI.
The study is a single-centre, prospective, randomised trial with blinded evaluation of endpoints. The planned inclusion is 540 patients with acute NSTEMI who are candidates for urgent PCI.
If thrombus aspiration leads to significant improvement of myocardial perfusion in patients with acute NSTEMI it may become part of the standard interventional approach.
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, Investigator)
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
- •Diagnosis of acute NSTEMI defined by
- •Chest pain suggestive for myocardial ischemia for at least 30 minutes,
- •Time from onset of symptoms of less than 72 hours
- •ECG with ST-segment shifts (depression of >0.1 mV in at least two contiguous leads or transient ST-segment elevation >0.1 mV in at least two contiguous leads for less than 30 minutes) and/or T-wave changes (inversion of >0.15 mV in at least two contiguous leads)
- •Positive cardiac troponin T >0,01 μg/L.
- •Clinical indication for urgent PCI of the ischemia-related target lesion as identified at coronary angiography
排除标准
- •Persistent ST-elevation of more than 0.1 mV in 2 or more leads
- •Presence of cardiogenic shock
- •Inability to obtain informed consent
- •Known existence of a life-threatening disease with a life expectancy of less than 6 months
结局指标
主要结局
Incidence of myocardial blush grade 3 after PCI
时间窗: During PCI procedure
次要结局
- Histopathological outcomes of atherothrombotic material(After inclusion is stopped: mean 1 year (storage at -80 degrees Celcius))
- Enzymatic infarct size(During hospital stay)
- Clinical outcomes at 30 days and 1 year(30 days till 1 year)
- Coronary angiographic outcomes(During PCI procedure)
- Electrocardiographic outcomes(30 to 60 minutes after PCI)