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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01438723
Recruitment Status : Completed
First Posted : September 22, 2011
Last Update Posted : July 29, 2014
Information provided by (Responsible Party):
Radboud University

Brief Summary:


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

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Ischemic Heart Disease Drug: Metformin Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Metformin in CABG (MetCAB) Trial
Study Start Date : November 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: metformin Drug: Metformin
prior to CAGB surgery 3 day treatment with metformin 500 mg three times a day
Other Name: Glucophage

Placebo Comparator: placebo Drug: Placebo
prior to CABG surgery 3 day treatment with placebo capsules three times a day

Primary Outcome Measures :
  1. Hs-Troponin-I [ Time Frame: within 24 hours after CABG ]
    high sensitive cardiac troponin-I

Secondary Outcome Measures :
  1. Post operative occurrence of arrhythmias [ Time Frame: within 24 hours after CABG ]
  2. Duration of inotropic support [ Time Frame: within two days after CABG ]
  3. Time to detubation [ Time Frame: within two days after CABG ]
  4. Post-ischemic recovery of contractile function of atrial trabeculae [ Time Frame: until 4 hours after harvesting ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01438723

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Nijmegen, Gelderland, Netherlands
Sponsors and Collaborators
Radboud University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Radboud University Identifier: NCT01438723     History of Changes
Other Study ID Numbers: MetCAB
2011-000099-33 ( EudraCT Number )
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: November 2011

Keywords provided by Radboud University:
ischemia reperfusion injury

Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Hypoglycemic Agents
Physiological Effects of Drugs