NCT01438723

The Metformin in Coronary Artery Bypass Graft (CABG) (MetCAB) Trial

The Metformin in CABG (MetCAB) Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Cardiovascular Disease
• Ischemic Heart Disease

Interventions

Type	Name	Description
DRUG	Metformin	prior to CAGB surgery 3 day treatment with metformin 500 mg three times a day
DRUG	Placebo	prior to CABG surgery 3 day treatment with placebo capsules three times a day

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2011-09-22
• Last updated: 2014-07-29

Locations

1 site across 1 country: Netherlands