Effects of Melatonin on Reperfusion Injury in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- The salvage index
研究概览
简要总结
Acute myocardial infarction is a major cause of mortality and morbidity. Primary percutaneous coronary intervention (pPCI) is currently the most effective treatment strategy in acute myocardial infarction. However, a sizable number of patients fail to restore optimal myocardial reperfusion, mostly because of the 'no-reflow' phenomenon. Melatonin is the chief indoleamine produced by the pineal gland, and a well-known antioxidant and free radical scavenger. Several studies have shown that melatonin protects against ischemia/reperfusion injury (IRI). In our previous study, melatonin markedly reduced infarcted area, improved cardiac function and reduced lactate dehydrogenase release in rats. The investigators planned to research the cardioprotective effects of intravenous melatonin administered prior to reperfusion and continued after restoration of coronary blood flow in patients with ST segment elevation myocardial infarction undergoing pPCI.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ST segment elevation myocardial infarction undergoing primary percutaneous poronary intervention
排除标准
- •unconscious at presentation
- •had cardiogenic shock
- •had a history of myocardial infarction
- •stent thrombosis
- •renal insufficiency
- •had previously undergone coronary artery bypass surgery
研究组 & 干预措施
Melatonin group
Patients will receive a total intravenous melatonin dose of 11.61 mg (aproximately 166 μg/kg).
干预措施: melatonin (Helsinn Chemical Co, Biasca, Switzerland) (Drug)
Control group
Patients will receive the same dose of placebo.
干预措施: Placebos (Drug)
结局指标
主要结局
The salvage index
时间窗: 3 months after primary percutaneous coronary intervention
The salvage index measured by cardiac magnetic resonance
次要结局
- major adverse cardiovascular events (MACE)(3 months after primary percutaneous coronary intervention)
- The final infarct size(3 months after primary percutaneous coronary intervention)
- treatment-emergent adverse events (TEAEs)(3 months after primary percutaneous coronary intervention)
研究者
Chen Wei Ren, MD
doctor
Chinese PLA General Hospital
