Safety and Efficacy of Thrombus Aspiration in Patients With ST-segment Elevation Myocardial Infarction (STEMI)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Major adverse cardiac events
研究概览
简要总结
This is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI).
详细描述
This is a prospective, randomized study with blinded outcome assessment, comparing routine manual thrombus aspiration with no aspiration in patients with acute ST-segment elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI). Patients who are diagnosed as STEMI and referred for PCI will be enrolled. They will be randomized 1:1 to either manual thrombus aspiration with PCI group or PCI alone group.The primary outcome is the composite of cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, stroke, new or worsening NYHA class IV heart failure during 1 year follow-up. The secondary efficacy outcome are stent thrombosis, target vessel revascularization, left ventricular function and quality of life during 1 year follow-up.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-80;
- •Diagnosed as STEMI for presenting symptoms or definite ECG and myocardial markers changes;
- •Patients presenting with definite ECG changes indicating STEMI: ST elevation of 0.1 mV in 2 contiguous limb leads or ≥0.2 mV in 2 contiguous precordial leads;
- •Referred for PCI for presenting symptoms, and the coronary angiogram (CAG) shows that the initial TIMI thrombus grade ≥2;
- •Informed consent.
排除标准
- •Previous history of myocardiopathy, valvular heart disease or severe heart failure;
- •Severe hepatic or renal dysfunction;
- •Life expectancy less than 1 year;
- •Prior PCI or CABG;
- •Contraindications of using anticoagulation or antiplatelet drugs.
结局指标
主要结局
Major adverse cardiac events
时间窗: 1 year
number of participants with cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, stroke, new or worsening NYHA class IV heart failure
次要结局
- Number of participants with stent thrombosis(1 year)
- left ventricular function(1 year)
- Seattle Angina Questionnaire scores(1 year)
- 6-minute walk distance (6MWD)(1 year)
- Number of participants with target vessel revascularization(1 year)
研究者
sunddong
Principal Investigator
Xijing Hospital