Investigation Into Cardioprotective Effect of Glucagon-like Peptide-1 and it's Mechanism of Action During Myocardial Ischaemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in Isovlumetric Relaxation Constant - Tau (ms)
研究概览
简要总结
Ischaemic heart disease is the most common cause of death in the UK. Glucagon-like peptide-1 (GLP-1) has been demonstrated to protect the heart when it is deprived of blood supply (ischaemia). The mechanism for this protection is not clear. Similar protection occurs with ischaemic conditioning of the heart, which is dependent on potassium channel opening.
The investigators intend to establish whether GLP-1 mediated protection shares a similar mechanistic pathway. In order to do this the investigators will measures pressure--volume loops generated in the main pumping chamber of the heart at the time of a percutaneous coronary intervention (stenting). Patients will be allocated to GLP-1 alone, GLP-1 with glibenclamide (a potassium channel blocking medication approved for human use), saline control or glibenclamide alone.
The investigators hypothesis is that the effect of GLP-1 will be abrogated by use of glibenclamide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- None
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
- •Age over 18
- •Able to give informed consent
- •Elective percutaneous intervention for a single vessel coronary stenosis
- •Normal left ventricular function
排除标准
- •Severe Co-morbidity
- •Type 2 Diabetes Mellitus
- •Nicorandil, Sulphonylureas, DPP4 inhibitors, GLP-1 agonists or Insulin use
- •Women of child bearing age
- •Myocardial infarction in previous three months
- •Previous coronary artery bypass grafts
研究组 & 干预措施
GLP-1 (7-36) amide and Glibenclamide
Patients will receive 5mg Glibenclamide orally prior to PCI and infusion of GLP-1 (7-36) amide 1.2 pmol/Kg/min during PCI
干预措施: GLP-1 (7-36) amide (Drug)
GLP-1 (7-36) amide and Glibenclamide
Patients will receive 5mg Glibenclamide orally prior to PCI and infusion of GLP-1 (7-36) amide 1.2 pmol/Kg/min during PCI
干预措施: Glibenclamide (Drug)
Glibenclamide alone
Glibenclamide 5 mg orally prior to PCI
干预措施: Glibenclamide (Drug)
GLP-1 (7-36) amide
GLP-1 (7-36) amide
干预措施: GLP-1 (7-36) amide (Drug)
结局指标
主要结局
Change in Isovlumetric Relaxation Constant - Tau (ms)
时间窗: Measured at the time of procedure
The isovolumetric relaxation constant, Tau, a measure of left ventricular diastolic function, will be measured during the second balloon occlusion of the coronary artery. This will be measured on pressure-volume loop using a conductance catheter.
次要结局
- Left Ventricular Ejection Fraction (%)(Measured at the time of the procedure)
- Maximal rate of change with time of left ventricular pressure - dP/dt max (mmHg/s)(Measured at the time of the procedure)
- Minimum rate of change with time of left ventricular pressure - dP/dt min (mmHg/s)(Measured at the time of procedure)