Cardioprotective Effects of Exenatide in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention ; Results of Exenatide Myocardial Protection In REvascularization (EMPIRE) Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Infarct size
研究概览
简要总结
Experimental evidence suggests exenatide, a glucagon-like peptide 1 receptor analogue, has significant cardiovascular protective effects in various conditions. The investigators examined whether conventional use of exenatide at the time of primary percutaneous coronary intervention would reduce the infarct size in patients with ST-segment elevation myocardial infarction (STEMI).
详细描述
In this proof-of-concept trial, we assessed the effects of acute-phase adjunctive exenatide therapy in patients with STEMI.
Infarct size after STEMI was evaluated by both cardiac magnetic resonance image and cardiac biomarkers compared with standard treatment.
LV function was assessed by conventional and speckle tracking echocardiography. During 6-month follow up, the safety/tolerability of exenatide and clinical outcomes were also assessed.
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 (Participant)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 20 and 79 years
- •patients presenting with first ST-segment elevation myocardial infarction
- •Thrombolysis in Myocardial Infarction [TIMI] flow grade 0)
排除标准
- •cardiac arrest
- •ventricular fibrillation
- •cardiogenic shock
- •hemodynamic instability
- •suspicious stent thrombosis
- •left bundle branch block
- •previous acute myocardial infarction
- •previous coronary artery bypass operation
- •significant valvular heart disease
- •primary myocardial disease
- •atrial fibrillation
- •significant hepatic or renal dysfunction, hypoglycaemia,
- •diabetic ketoacidosis
- •active infection or chronic inflammatory disease
- •malignancy
- •women who were pregnant or who were of childbearing age
研究组 & 干预措施
Exenatide
Drug: Exenatide
10 μg subcutaneous and 10 μg intravenously injection of exenatide BYETTA® (Amylin-Lilly) 5 min before the onset of reperfusion. And twice daily 10 μg subcutaneous injection was continued on the following 2 days.
干预措施: exenatide BYETTA® (Amylin-Lilly) (Drug)
Saline
Drug: Saline
10 μg subcutaneous and 10 μg intravenously injection of equivalent volume of normal saline 5 min before the onset of reperfusion. And twice daily 10 μg subcutaneous injection was continued on the following 2 days.
干预措施: Saline (Drug)
结局指标
主要结局
Infarct size
时间窗: 1 month
Infarct size was assessed by measuring the release of creatine kinase-MB and troponin I during 72 hours and by performing cardiac magnetic resonance imaging on 1 month after infarction.
次要结局
- Number of Participants with Adverse Events(6 month after primary PCI)
- LV function(at admission and 6 month after primary PCI)
- Clinical outcomes(6 months after primary PCI)
研究者
Weon Kim
associate professor
Kyunghee University Medical Center