A Study to Investigate the Protective Effects of Glucagon-like Peptide-1 (GLP-1) in Patients Undergoing Elective Angioplasty and Stenting (GOLD-PCI)
试验速览
- 阶段
- 2 期
- 入组人数
- 193
- 试验地点
- 1
- 主要终点
- Plasma Troponin I level
研究概览
简要总结
Angina is caused by narrowings or blockages within coronary arteries. Coronary angioplasty and stenting is performed for people with angina to improve the blood supply to the heart by placing metal tubes within the artery using balloon inflation. The procedure risks small but significant damage to the heart muscle downstream of the balloon.
Glucagon like peptide 1 (GLP 1) is a naturally occurring hormone secreted by cells in the gut in response to food. It acts by stimulating the release of insulin. In the heart it acts to increase glucose uptake into cardiac muscle. GLP-1 can protect the heart and improve heart muscle performance in people with coronary artery disease in physiological studies. This study which assesses whether GLP-1 protects the heart during coronary angioplasty and stenting.
The hypothesis is that GLP-1 given during elective coronary angioplasty and stenting will reduce cardiac troponin rise (a measure of heart muscle damage) compared to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Normal Saline
Infusion of Normal Saline during Percutaneous Coronary Intervention
干预措施: placebo (Drug)
GLP-1
Infusion of GLP-1 (7-36) amide during elective percutaneous coronary intervention
干预措施: GLP-1 (Drug)
结局指标
主要结局
Plasma Troponin I level
时间窗: 6 Hours following angioplasty or stenting
Incidence of Troponin I elevation of \> 5 x 99th percentile upper reference limit on blood test at approximately 6 hours post procedure.
次要结局
- Electrocardiographic (ECG) Changes during procedure(Assessed during procedure)
- Ischaemic symptoms during balloon occlusion(Assessed during procedure)
- Major Adverse Cardiovascular or Cerebrovascular Event (MACCE) Rates(From date of randomisation until the date of first event assessed up to 6 months)
- Plasma Creatine Kinase - Myocardial Bound (CKMB) level(6 hours)
- Myocardial Flow Grade after Angioplasty or Stenting(Measured during procedure)
- MACCE Rates(From date of randomisation until the date of first event assessed up to 60 months)
- Myocardial Blush Grade following angioplasty or stenting(Measured during procedure)