The Randomized Physiologic Assessment of Thrombus Aspiration in Patients With Acute ST-segment Elevation Myocardial Infarction Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 128
- 试验地点
- 3
- 主要终点
- IMR (mmHg seconds) in thrombus aspiration compared to conventional PCI group
研究概览
简要总结
The Physiologic Assessment of Thrombus Aspiration in ST-segment Elevation Myocardial Infarction (PATA-STEMI) trial is a single center, prospective, randomized trial with a planned inclusion of 128 patients with the first ST-segment elevation myocardial infarction (STEMI). Patients are, before coronary angiography, randomly assigned to thrombus aspiration using 6 or 7 French Eliminate aspiration catheter (Terumo Medical Supply, Japan) or to conventional primary percutaneous coronary intervention (PCI). The primary endpoint is index of microcirculatory resistance (IMR), measured in infarct-related artery, in thrombus aspiration compared to conventional PCI group.
详细描述
Background and Objective Routine thrombus aspiration is superior to conventional primary PCI in terms of improved myocardial perfusion in STEMI patients. However, myocardial perfusion after thrombus aspiration has not been evaluated by a quantitative, invasive method. Investigators intend to determine whether thrombus aspiration of the infarct-related artery increases myocardial perfusion, as measured by IMR, compared to conventional primary PCI.
Study design PATA-STEMI is a single center, prospective, randomized trial with a planned inclusion of 128 patients with the first STEMI. Patients are randomly assigned, before coronary angiography, to thrombus aspiration using the 6 or 7 French Eliminate aspiration catheter (Terumo Medical Supply, Japan) or to conventional primary PCI. The IMR will be determined in infarct-related artery and non-infarct-related arteries without critical stenosis to measure microcirculatory resistance. The primary endpoint is defined as IMR in infarct-related artery in thrombus aspiration compared to conventional PCI group. Secondary end points are myocardial perfusion grade and resolution of ST-segment elevation, infarct size and left ventricle remodeling, as assessed by echocardiographic indices. Transthoracic echocardiography will be conducted within 24 hours and at 4 months after the primary PCI.
Implications: If manual thrombus aspiration reduces microcirculatory resistance, indicating improved myocardial perfusion, as compared to conventional PCI, it might become the preferred strategy in patients with STEMI.
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
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive patients with STEMI
- •chest pain onset ≤12h, or >12 h with persistent ST-segment elevation
- •hemodynamically stable patients
排除标准
- •patients without diagnosis of STEMI (pericarditis, for example)
- •no written informed consent obtained
- •prior Q or non-Q MI
- •prior resuscitation
- •prior thrombolysis
- •prior surgical myocardial revascularisation
- •life expectancy <6 months
- •periprocedural death
结局指标
主要结局
IMR (mmHg seconds) in thrombus aspiration compared to conventional PCI group
时间窗: At the end of the primary PCI , an expected average of 45 minutes after sheath insertion
IMR will be measured after final balloon inflation or stent implantation, an expected average of 45 minutes after sheath insertion
次要结局
- Resolution of ST-segment elevation(at 60 minutes after guiding catheter removal)
- myocardial blush grade (0-3)(at final angiogram, an expected average of 55 minutes after sheath insertion)
- infarct size assessed by peak enzyme release (Troponin, creatine kinase MB (CK-MB))(in hospital course after primary PCI, an expected average of 5 days)
- indices of left ventricle remodeling on Echocardiography(within 24 hours and at 4 months after primary PCI)
- infarct size determined by SPECT(within 7-14 days and at 4 months after primary PCI)
研究者
Dejan Orlic
MD
Clinical Centre of Serbia