The Safety and Efficacy of Etanercept in Treating Patient With Acute ST Segment Elevated Myocardial Infarction
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, fatal myocardial infarction and fatal stroke
研究概览
简要总结
Our aim is to observe whether anti-TNF-alpha regimen will effect serum adiponectin concentration after myocardial infarction/reperfusion and also beneficial for the patients undergoing percutaneous coronary intervention (PCI).
详细描述
Ischemic/reperfusion injury in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) is associated with increased inflammatory cytokines that including TNF-alpha that can exert deleterious effects and therefore contribute to cardiac dysfunction and cardiomyocytes apoptosis. Several studies on rodents have reported administration of sTNFR-Fc, a scavenger of the pro-inflammatory cytokine TNF-alpha at the time of reperfusion would protect against ischemic/reperfusion injury. Also reports had shown that serum TNF-alpha concentration is negatively correlated with a cardioprotective cytokine adiponectin. Adiponectin (Ad) is an abundant protein hormone regulatory of numerous metabolic processes. The major intracellular pathway activated by Ad includes phosphorylation of AMP-activated protein kinase, which is responsible for many of Ad's metabolic regulatory, anti-inflammatory, vascular protective, and anti-ischemic properties. The aim of the present study was to verify whether the administration of Etanercept, an FDA approved rheumatoid arthritis treating sTNFR-Fc, at the reperfusion time would protect against ischemic/reperfusion injury on patient, and effect serum adiponectin level.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with acute ST segment elevated myocardial infarction in 12h
排除标准
- •Cardiogenic shock
- •old myocardial infarction
- •other causes of cardiac insufficiency
- •Coronary anatomy unsuitable for PCI or Need of emergency coronary artery by-pass grafting
- •Pregnancy
研究组 & 干预措施
Etanercept
干预措施: Etanercept (Drug)
saline
干预措施: saline (Drug)
结局指标
主要结局
Composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, fatal myocardial infarction and fatal stroke
时间窗: 30 days
次要结局
- Composite endpoint of major cardiovascular events, non-elective coronary revascularization procedures and hospitalization for unstable angina Cardiovascular death Non-fatal myocardial infarction Non-fatal stroke of all classifications(30 days)
- Elevation of ALT, AST and CK(30 days)
- serum adiponectin concentration, activity and isoforms(30 days)
