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临床试验/NCT01438723
NCT01438723已完成4 期

The Metformin in CABG (MetCAB) Trial

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年11月最近更新:
适应症
干预措施

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
Hs-Troponin-I

研究概览

简要总结

Rationale:

In patients with a myocardial infarction, occlusion of a coronary artery induces myocardial ischemia and cell death. If untreated, the area of myocardium exposed to this interruption in blood supply, will largely become necrotic. The only way to limit final infarct size, is timely reperfusion of the occluded artery. Paradoxically, however, reperfusion itself can also damage myocardial tissue and contribute to the final infarct size ("reperfusion injury"). Also during coronary artery bypass grafting (CABG), the myocardium is exposed to ischemia and reperfusion, which will induce cell death. Indeed, postoperatively, the plasma concentration of troponin I, a marker of cardiac necrosis, is increased, and associated with adverse outcome. The anti-hyperglycaemic drug metformin has been shown in preclinical studies to be able to reduce ischemia-reperfusion injury and to limit myocardial infarct size. Moreover, metformin therapy improves cardiovascular prognosis in patients with diabetes mellitus. Paradoxically, in patients with diabetes, current practice is to temporarily stop metformin before major surgery for the presumed risk of lactic acidosis, which is a rare complication of metformin. However, here is no evidence that this practice benefits the patient. The investigators hypothesize that pretreatment with metformin can reduce myocardial injury in patients undergoing elective CABG surgery

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Acceptation for CABG with or without concomitant valve surgery
  • Informed consent
  • Age ≥ 18 years

排除标准

  • Diabetes mellitus
  • Renal dysfunction (MDRD < 60 ml/min)
  • Elevated liver enzymes (ALAT > 3 times upper limit of reference range)
  • Treatment with dipyridamole or xanthine derivatives
  • Recent myocardial infarction (<2 weeks before inclusion)
  • Off-pump surgery

研究组 & 干预措施

metformin

Experimental

干预措施: Metformin (Drug)

placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Hs-Troponin-I

时间窗: within 24 hours after CABG

high sensitive cardiac troponin-I

次要结局

  • Post operative occurrence of arrhythmias(within 24 hours after CABG)
  • Duration of inotropic support(within two days after CABG)
  • Time to detubation(within two days after CABG)
  • Post-ischemic recovery of contractile function of atrial trabeculae(until 4 hours after harvesting)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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