Assessment of Efficacity of Coronary Thromboaspiration (Export System) Performed Before Angioplasty on Infarct Size in Patients Treated by Coronary Percutaneous Interventions During Acute Phase.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Infarct size and severity assessed by ce-MRI and rest Tc99m-mibi gated SPECT
研究概览
简要总结
Distal embolization can occur during coronary angioplasty performed in the acute phase of myocardial infarction and is associated with poor long-term outcome. We hypothesize that the use of a system allowing thrombus aspiration before angioplasty and stent implantation will limit infarct size and its severity.
详细描述
Patients scheduled for emergency angioplasty in the acute phase of a first ST-elevation myocardial infarction will be treated either by thromboaspiration followed by angioplasty or by angioplasty alone. The infarct size and severity will be assessed by ce-MRI and rest Tc99m-mibi gated SPECT performed during initial hospital stay (5th-8th day). A control MRI will be performed at 6-month follow-up to analyse the evolution of left ventricular volumes.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •acute phase of myocardial infarction (>48 hours from the onset of chest pain)
- •stable hemodynamic conditions
- •completely occluded infarct related artery
排除标准
- •heart failure signs in the acute phase
- •contra indication for MRI or SPECT IMAGING
结局指标
主要结局
Infarct size and severity assessed by ce-MRI and rest Tc99m-mibi gated SPECT
时间窗: by ce-MRI and rest Tc99m-mibi gated SPECT
次要结局
- Probability of evolution toward left ventricular remodelling (defined as an increase of end-diastolic volume of>20% between the acute phase and 6-montcontrol)(of end-diastolic volumeof>20% between the acute phase and 6-montcontrol))