跳至主要内容
临床试验/NCT03303378
NCT03303378Unknown不适用

Effects of Melatonin on Reperfusion Injury in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2017年11月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Placebo Comparator

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

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen Wei Ren, MD

doctor

Chinese PLA General Hospital

研究点 (1)

Loading locations...

相似试验