Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- coronary reserve after intracoronary adenosine injection
研究概览
简要总结
The purpose of this study is to determine whether brief periods of ischemia performed just at the time of reperfusion -postconditioning- can reduce coronary endothelial dysfunction and infarct size in humans
详细描述
Desobstruction of the culprit artery after acute myocardial infarction allows to reduce the consequences of prolonged ischemia. However, it is now clearly established that reperfusion induces by itself severe myocardial injuries. Postconditioning has been described as an adaptive response triggered by a brief ischemia applied after a prolonged coronary occlusion. Several teams have reported that ischemia/reperfusion cycles allow to reduce infarct size in experimental models.
Different pathophysiological processes have been proposed to explain the beneficial effect of postconditioning. It has been reported that postconditioning reduces the inflammatory response, and activates cardioprotective signaling pathways (Akt, eNOS, p70S6K). In addition, an improvement of the endothelial function has been reported.
This controlled trial aim to study the potential beneficial effect of postconditioning in patients with acute myocardial infarction. Forty six patients will be included in the study and the culprit artery will be reoccluded three times for 1 minutes after desobstruction in one of the both groups after randomization of the patients.
The evaluation will be focused on the comparison of the coronary reserve after intracoronary adenosine injection. In addition, additional parameters will be used to study the effect of postconditioning on post-ischemic endothelial dysfunction: frequencies of low reflow and slow reflow situation, myocardial blush and regression of ST elevation. The effect of postconditioning on the left ventricular systolic function will be studied by Doppler tissue imaging and RMN.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myocardial infarction (<6 hours)
- •Occlusion of a major coronary vessel
排除标准
- •History of previous myocardial infarction
- •History of Coronary Artery Bypass Grafting
- •Need for Coronary Artery Bypass Grafting
- •Stenosis not eligible for angioplasty
- •Limited ischemic area
- •Cardiogenic shock
- •Interventricular septum rupture
- •Mitral regurgitation>2
- •Ventricular tachycardia
- •Atrioventricular block class II and III
研究组 & 干预措施
-postconditioning group
干预措施: postconditioning (Procedure)
- Control
干预措施: Control group (Procedure)
结局指标
主要结局
coronary reserve after intracoronary adenosine injection
时间窗: Immediately after the postconditioning procedure
次要结局
- frequencies of low reflow and slow reflow situation(after postconditioning)
- regression of ST elevation(1h and 24h after postconditioning)
- left ventricular systolic function by Doppler tissue imaging (DAY 1 and 6)(day 1 and 6)
- left ventricular systolic function by RMN(day 8-12)
- myocardial blush(after postconditioning)