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Completed

NCT Number: NCT01438723

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

RUNMC

Nijmegen, Gelderland, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

prior to CAGB surgery 3 day treatment with metformin 500 mg three times a day

Other names: Glucophage

Placebo

Drug

prior to CABG surgery 3 day treatment with placebo capsules three times a day

Primary outcomes

  1. Hs-Troponin-I

    Time frame: within 24 hours after CABG

    high sensitive cardiac troponin-I

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

The Metformin in CABG (MetCAB) Trial

Acronym: MetCAB

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 22, 2011
Registry last updated
Jul 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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