Protective Effect of Glucagonlike Peptide-1 on Reperfusion Injury in Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- the salvage index measured by cardiac magnetic resonance
研究概览
简要总结
The investigators planned to research the cardioprotective effects of intravenous liraglutide on reperfusion injury.
详细描述
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. Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and recently GLP-1 analogues have been introduced for the treatment of type-2 diabetes. In experimental studies, GLP-1 or its analogues protect against reperfusion injury-induced cell death. Exenatide reduces reperfusion injury in patients with ST-segment elevation myocardial infarction. Liraglutide(GLP-1) is safe and effective to reduce weight,serum lipid levels and blood pressure. Liraglutide can reduce cardiac rupture (12 of 60 versus 46 of 60; P=0.0001) and infarct size (21±2% versus 29±3%, P=0.02) and improved cardiac output (12.4±0.6 versus 9.7±0.6 ml/min; P=0.002) in normal and diabetic mice. The investigators planned to research the cardioprotective effects of intravenous liraglutide administered prior to reperfusion and continued after restoration of coronary blood flow in patients with STEMI 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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were eligible if they were 18 years or older and presented within 12 h from the onset of symptoms and signs of ST-segment elevation myocardial infarction to the catheterization laboratory.
排除标准
- •The patients were not considered for enrolment if they presented with unconsciousness, cardiogenic shock, hypoglycaemia, diabetic ketoacidosis, previous myocardial infarction, stent thrombosis, known renal insufficiency, or previous coronary artery bypass operation.
研究组 & 干预措施
liraglutide
drug: liraglutide (Novo Nordisk, Bagsværd, Denmark) duration:7 days(from admission (primary percutaneous coronary intervention) to discharge) the intervention:once-daily subcutaneous liraglutide 0.6 mg for 2 days, then gradually increase the dosage, once-daily subcutaneous liraglutide 1.2 mg for 2 days ,once-daily subcutaneous liraglutide 1.8 mg for 3 days
干预措施: liraglutide (Novo Nordisk, Bagsværd, Denmark) (Drug)
liraglutide placebo
drug:liraglutide placebo (Novo Nordisk) duration:7 days(from admission (primary percutaneous coronary intervention) to discharge) the intervention:once-daily subcutaneous liraglutide placebo 0.6 mg for 2 days, then gradually increase the dosage, once-daily subcutaneous liraglutide placebo 1.2 mg for 2 days ,once-daily subcutaneous liraglutide placebo 1.8 mg for 3 days
干预措施: liraglutide placebo (Novo Nordisk) (Drug)
结局指标
主要结局
the salvage index measured by cardiac magnetic resonance
时间窗: 3 months after primary percutaneous coronary intervention
The primary endpoint was the salvage index measured by cardiac magnetic resonance after 3 months.
次要结局
- final infarct size after 3 months(3 months after Primary percutaneous coronary intervention)
- major adverse cardiovascular events (MACE) after 3 months(3 months after Primary percutaneous coronary intervention)
- the levels of high-sensitivity C-reactive protein (hsCRP)(3 months after Primary percutaneous coronary intervention)
- nitric oxide (NO) levels(3 months after Primary percutaneous coronary intervention)
研究者
Chen Wei Ren, MD
Dr.
Chinese PLA General Hospital