The Metformin in Coronary Artery Bypass Graft (CABG) (MetCAB) Trial
Overview[ - collapse ][ - ]
Purpose | 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 |
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Condition | Cardiovascular Disease Ischemic Heart Disease |
Intervention | Drug: Metformin Drug: Placebo |
Phase | Phase 4 |
Sponsor | Radboud University |
Responsible Party | Radboud University |
ClinicalTrials.gov Identifier | NCT01438723 |
First Received | September 21, 2011 |
Last Updated | April 26, 2013 |
Last verified | November 2011 |
Tracking Information[ + expand ][ + ]
First Received Date | September 21, 2011 |
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Last Updated Date | April 26, 2013 |
Start Date | November 2011 |
Estimated Primary Completion Date | December 2013 |
Current Primary Outcome Measures | Hs-Troponin-I [Time Frame: within 72 hours after CABG] [Designated as safety issue: No]high sensitive cardiac troponin-I |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | The Metformin in Coronary Artery Bypass Graft (CABG) (MetCAB) Trial |
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Official Title | The Metformin in CABG (MetCAB) Trial |
Brief 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 |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention |
Condition |
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Intervention | Drug: Metformin prior to CAGB surgery 3 day treatment with metformin 500 mg three times a day Other Names: GlucophageDrug: Placebo prior to CABG surgery 3 day treatment with placebo capsules three times a day |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 110 |
Estimated Completion Date | December 2013 |
Estimated Primary Completion Date | July 2013 |
Eligibility Criteria | Inclusion Criteria: - Acceptation for CABG with or without concomitant valve surgery - Informed consent - Age ≥ 18 years Exclusion Criteria: - 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: S El Messaoudi, MD MSc +31 24 3616723 S.ElMessaoudi@cardio.umcn.nl |
Location Countries | Netherlands |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01438723 |
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Other Study ID Numbers | MetCAB |
Has Data Monitoring Committee | Yes |
Information Provided By | Radboud University |
Study Sponsor | Radboud University |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | November 2011 |
Locations[ + expand ][ + ]
RUNMC | Nijmegen, Gelderland, Netherlands Contact: S El Messaoudi, MD MSc | +31 24 3616723 | S.ElMessaoudi@cardio.umcn.nlPrincipal Investigator: G Rongen, MD PhD Recruiting |
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