Cardioprotective Effects of Remote Ischemic Perconditioning in Patients With ST-segment Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Infarct size measured by contrast-enhanced cardiac magnetic resonance
研究概览
简要总结
To evaluate whether remote ischemic per-conditioning (RIPC) can reduce infarct size in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention (PPCI) within 12 hours of symptoms onset.
- Control group: PPCI only
- Study group: PPCI + RIPC
Primary endpoint: Infarct size measured by contrast-enhanced cardiac magnetic resonance (CMR) at 6 months after the index procedure
详细描述
ST-elevation myocardial infarction (STEMI) is a leading cause of mortality and morbidity. Early myocardial reperfusion with either of thrombolytic therapy or primary percutaneous coronary intervention (PPCI) is the most effective strategy for reducing the size of a myocardial infarct and improving the clinical outcome. Although this process can restore blood flow to the ischemic myocardium, it can induce injury. This phenomenon termed myocardial reperfusion injury can paradoxically reduce the beneficial effects of myocardial reperfusion. The pre-clinical study in animal models of acute myocardial infarction suggests that lethal reperfusion injury accounts for up to 50% of the final size of a myocardial infarct.
Remote ischemic conditioning uses brief ischemia and reperfusion of a distant organ to protect the myocardium. In animal study, remote ischemic postconditioning seems to be more effective than local postconditioning in experimental myocardial infarction.Bøtker et al. has reported remote ischemic preconditioning before hospital admission increase myocardial salvage in patients with acute myocardial infarction.
The objective of this study is to evaluate whether remote ischemic per-conditioning (RIPC) can reduce late infarct size in patients with STEMI treated with PPCI within 12 hours of symptoms onset. To test this hypothesis, we will randomize patients into PPCI + RIPC or PPCI alone. We will evaluate marker of reperfusion injury using contrast cardiac magnetic resonance image.
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)
盲法说明
CMR results will be interpreted by observers blinded to randomization
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >19 years
- •Presenting within 12 hours of symptom onset
- •>20 min of chest pain
- •ST-elevation myocardial infarction defined as ST-segment elevation (>0.1 mV) in at least 2 contiguous precordial leads
排除标准
- •Previous myocardial infarction
- •Presence of chronic total occlusion
- •Evidence of retrograde filling by collaterals at coronary angiography (Rentrop 2 or 3 collateral flow)
- •Severe multi-vessel coronary artery disease to require further interventions before follow-up CMR
- •Cardiac arrest before randomization
- •Arrhythmias requiring external electric shock before randomization
- •Unwillingness to participate
- •External electric shock for cardioversion within first 3 days
- •Cardiac surgery within first 3 days
结局指标
主要结局
Infarct size measured by contrast-enhanced cardiac magnetic resonance
时间窗: 6 months after index procedure
Infarct size will be assessed on late-contrast images (≈10 min after gadolinium administration) by manually tracing the hyperintense area in each short-axis slice.
次要结局
- Enzymatic Infarct Size(1 to 5 days after index procedure)
- Resolution of ST-segment deviation(1 to 5 days after index procedure)
- Acute kidney injury(1 to 3 days after index procedure)
研究者
Young Jin Youn, MD, PhD
Professor, Division of Cardiology, Department of Internal Medicine, Yonsei Univeristy Wonju College of Medicine
Yonsei University