Effects of Melatonin on Reperfusion Injury
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状态
赞助商
Chinese PLA General Hospital
临床试验: NCT03303378
BioSeek: NCT03303378
关键词
抽象
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.
日期
| 最后验证: | 09/30/2017 |
| 首次提交: | 10/01/2017 |
| 提交的预估入学人数: | 10/03/2017 |
| 首次发布: | 10/05/2017 |
| 上次提交的更新: | 10/03/2017 |
| 最近更新发布: | 10/05/2017 |
| 实际学习开始日期: | 10/31/2017 |
| 预计主要完成日期: | 10/31/2019 |
| 预计完成日期: | 10/31/2019 |
状况或疾病
Reperfusion Injury, Myocardial
干预/治疗
Drug: Melatonin group
Drug: Control group
相
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手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Melatonin group Patients will receive a total intravenous melatonin dose of 11.61 mg (aproximately 166 μg/kg). | Drug: Melatonin group Patients will receive a total intravenous melatonin (Helsinn Chemical Co, Biasca, Switzerland) dose of 11.61 mg (aproximately 166 μg/kg). The dose will be distributed in a volume of 500 ml of an isotonic and sterile solution of 100 μM melatonin during 150 min with a drip rate of 4.2 ml/min.
The temporal distribution of perfusion will be: 30 min previous to percutaneous revascularization and remainder doses in a subsequent 120 min (1 h during the angioplasty +60 min post-intervention). |
| Placebo Comparator: Control group Patients will receive the same dose of placebo. | Drug: Control group The temporal distribution of perfusion will be: 30 min previous to percutaneous revascularization and remainder doses in a subsequent 120 min (1 h during the angioplasty +60 min post-intervention). |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: ST segment elevation myocardial infarction undergoing primary percutaneous poronary intervention Exclusion Criteria: - unconscious at presentation - had cardiogenic shock - had a history of myocardial infarction - stent thrombosis - renal insufficiency - had previously undergone coronary artery bypass surgery |
结果
主要结果指标
1. The salvage index [3 months after primary percutaneous coronary intervention]
The salvage index measured by cardiac magnetic resonance
次要成果指标
1. The final infarct size [3 months after primary percutaneous coronary intervention]
The final infarct size measured by cardiac magnetic resonance
2. major adverse cardiovascular events (MACE) [3 months after primary percutaneous coronary intervention]
recurrent myocardial infarction, recurrent angina, revascularization, heart failure, cardiac death.
3. treatment-emergent adverse events (TEAEs) [3 months after primary percutaneous coronary intervention]
hypoglycemia, nausea
