Postconditioning and Functional Recovery After Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Infarct size as measured by cardiac enzymes and MRI at day 5 to 7
研究概览
简要总结
We previously demonstrated that postconditioning by coronary angioplasty can decrease infarct size (as measured by cardiac enzyme release) in patients with ongoing acute myocardial infarction. It is currently unknown whether postconditioning actually decreases or simply delays myocardial cell death during reperfusion. In addition, the long term effects of postconditioning on recovery of myocardial contraction remains elusive. The objective of the present study is to determine whether infarct size reduction by angioplasty postconditioning is maintained at 6 months and whether functional recovery is improved at one year post-infarction.
详细描述
Randomized, controlled, single-blinded trial comparing postconditioning to control (no intervention). Postconditioning consists of four episodes of one minute inflation followed by one minute deflation of the angioplasty balloon, starting within one minute of reflow after direct stenting of the occluded coronary artery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients, aged more than 18, with suspected first acute myocardial infarction, within 6 hours of the onset of chest pain, with a need for emergency revascularization by angioplasty. Patients must display a fully occluded (TIMI zero flow) culprit coronary artery, absence of visible collaterals and exhibit TIMI flow >2 after direct stenting by angioplasty.
排除标准
- •Cardiac arrest or cardiogenic shock
- •occlusion of the circumflex coronary artery
研究组 & 干预措施
1
Post-conditioning during angioplasty
干预措施: Postconditioning (Procedure)
2
standard angioplasty
干预措施: standard angioplasty (Procedure)
结局指标
主要结局
Infarct size as measured by cardiac enzymes and MRI at day 5 to 7
时间窗: during 72 hours after angioplasty, and at day 5 to 7
次要结局
- Myocardial contraction (LV ejection fraction, wall motion score index, strain rate) measured by echocardiography at 6 month.(at 6 month)