Effects of Glucagon Like Peptide-1 on No-reflow 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
- a change in the prevalence of no-reflow
研究概览
简要总结
The investigators planned to evaluate the effects of liraglutide on no-reflow in patients with acute ST-segment elevation myocardial infarction (STEMI).
详细描述
Acute myocardial infarction (AMI) is a major cause of mortality and morbidity. Primary percutaneous coronary intervention (PCI) is currently the most effective treatment strategy for AMI. Brisk thrombolysis in myocardial infarction (TIMI) grade 3 flow immediately after PCI in patients with AMI is associated with improved clinical outcomes compared with lower flow grades. However, myocardial reperfusion is suboptimal in many patients, mostly because of the 'no-reflow' phenomenon. No-reflow is defined as suboptimal myocardial reperfusion in part of the coronary circulation without angiographic evidence of mechanical vessel obstruction. To date, however, very few drugs have been shown to reverse established no-reflow.
Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and GLP-1 analogues were recently introduced for the treatment of acute myocardial infarction. GLP-1 has antioxidant and anti-inflammatory properties, and may protect endothelial function. Experimental studies have also revealed that GLP-1 or its analogues protect against reperfusion injury in pigs. Exenatide, a GLP-1 analogue, was reported to reduce reperfusion injury in patients with ST-segment elevation myocardial infarction. Similarly, liraglutide was reported to reduce cardiac rupture and infarct size and improve cardiac output in normal and diabetic mice. To date, however, there is no clinical evidence for the effects of liraglutide on no-reflow in patients with AMI. Therefore, the aim of this study was to evaluate the effects of liraglutide pretreatment on myocardial no-reflow of prime PCI in patients with AMI.
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
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 ST-segment elevation myocardial infarction were eligible for the study.
排除标准
- •Patients were excluded for the following reasons: unconscious at presentation; had cardiogenic shock, hypoglycaemia, or diabetic ketoacidosis; had a history of myocardial infarction, stent thrombosis, or renal insufficiency; or had previously undergone coronary artery bypass surgery.
研究组 & 干预措施
GLP-1 group
The treatment started 30 min before PCI with a dose of 1.8 mg liraglutide (the treatment was administered in the ambulance).
干预措施: liraglutide (Drug)
Control group
the treatment started 30 min before PCI with a dose of 1.8 mg placebo (the treatment was administered in the ambulance).
干预措施: placebo (Drug)
结局指标
主要结局
a change in the prevalence of no-reflow
时间窗: immediately after PCI
The primary efficacy variable was the prevalence of no-reflow assessed immediately post procedure.
次要结局
- a change in troponin T(immediately after PCI, at 1,3,5 days after PCI)
- a change in high-sensitivity C-reactive protein (hsCRP)(immediately after PCI, at 1,3,5 days after PCI)
- a change in superoxide dismutase (SOD)(immediately after PCI, at 1,3,5 days after PCI)
研究者
Chen Wei Ren, MD
Dr.
Chinese PLA General Hospital
