Effect of Conditioning on Myocardial Damage in ST-elevation Myocardial Infarction - Comparison of Combined Intrahospital Preconditioning Plus Postconditioning Versus Postconditioning Versus Control.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Myocardial salvage assessed by MRI
研究概览
简要总结
The LIPSIA-Conditioning trial is an investigater initiated, randomized, single-center study that will assess the effect of different intrahospital conditioning protocols on myocardial damage assessed by MRI in patients with acute ST-elevation myocardial infarction.
The following groups will be compared:
- Combined intrahospital pre- plus postconditioning versus
- Postconditioning versus
- Control
详细描述
Rapid reperfusion of the infarct-related coronary artery is essential to salvage ischemic myocardium in patients with acute ST-elevation myocardial infarction (STEMI). Paradoxically, restoration of the blood flow to the ischemic area may result in further injury to the myocardium.
This phenomenon is described as 'ischemia/reperfusion injury' and the pathophysiological mechanisms are not fully elucidated. A cardioprotective effect of ischemic preconditioning as well for postconditioning (short repetitive cycles of reperfusion and re-occlusion) has been demonstrated in experimental studies and in pilot studies on patients with acute STEMI treated with primary percutaneous coronary intervention.
Aim of this study is to compare for the first time the combination of intrahospital pre- and postconditioning versus exclusive postconditioning versus control. The primary endpoint of this study will be the salvaged area at risk assessed by cardiac magnetic resonance imaging.
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
- None
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
- •ST-elevation myocardial infarction <12 hours
排除标准
- •Age ≤ 18 years
- •Patients presenting with pregnancy
- •Thrombolysis <12 hours
- •Patients without informed consent
- •Participation in another trial.
研究组 & 干预措施
Combined intrahospital pre- and postconditioning
After admission to hospital 3 cycles of preconditioning with 5-min inflation and 5-min deflation of a blood-pressure cuff. After primary PCI/stenting 4 cycles of postconditioning (30s ischemia and 30s reperfusion).
干预措施: Combined intrahospital pre- and postconditioning (Device)
Postconditioning
4 cycles of postconditioning (30s ischemia, 30s reperfusion) after primary PCI/stenting
干预措施: Postconditioning (Device)
Control group
Standard infarction treatment without conditioning intervention
结局指标
主要结局
Myocardial salvage assessed by MRI
时间窗: 1 week after infarction
次要结局
- Composite of death, reinfarction and readmission for congestive heart failure(6 months)