Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI in Patients With STEMI
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Infarct size by MRI
研究概览
简要总结
Both pre- and postconditioning seem to protect cardiomyocytes during reperfusion therapy. Investigations both ex vivo and in vivo suggest that a gut derived hormone, Glucagon-Like-Peptide-1 (GLP-1), is able to reduce reperfusioninjury after myocardial ischemia. Results from our own laboratory have shown a marked reduction in infarct size when rat hearts in a Langendorf preparation were exposed to the GLP-1 analogue, exendin-4. The investigators want to investigate to what extent this effect can be translated to humans in the setting of acute STEMI treated with primary PCI when evalutaed by cardiac magnetic resonance imaging.
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
- •More than 18 years of age.
- •STEMI less than 12 hours from onset of pain. STEMI defined as as ST-segment elevation in 2 contiguous electrocardiographic leads of >0.1 mV in V4 - V6 or limb leads II, III and aVF, or >0.2 mV in lead V1 - V
- •TIMI 0-1 in infarct related artery.
- •Oral and written informed consent.
排除标准
- •Multivessel disease defined by one or more stenoses >70% in diameter in the non infarct related artery.
- •Previous myocardial infarction.
- •Stent trombosis.
- •Previous CABG.
- •Less than TIMI 2 following wiring and predilatation of the infarct related artery but prior to postconditioning or placebo treatment.
- •Renal insufficiency (creatinin >200).
- •Pregnancy or lactation.
- •Diabetic ketoacidose eller hypoglycemia (plasma glukose < 2.5 mmol/l).
- •Pancreatitis.
研究组 & 干预措施
Exenatide
25 μg Byetta (Lilly, Exenatide) is added to 250 ml isotonic NaCl. Infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.
干预措施: Exenatide (Drug)
Saline
Isotonic saline infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.
干预措施: Saline (Drug)
结局指标
主要结局
Infarct size by MRI
时间窗: 3 months
次要结局
- Cardiel death after 1 and 15 months.(15 months)
研究者
Thomas Engstrom
Chief consultant
Rigshospitalet, Denmark