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

The Metformin in CABG (MetCAB) Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01438723
Acronym
MetCAB
Enrollment
100
Registered
2011-09-22
Start date
2011-11-30
Completion date
2014-07-31
Last updated
2014-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease, Ischemic Heart Disease

Keywords

ischemia reperfusion injury, CABG, metformin, Hs-troponin-I

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

Interventions

DRUGMetformin

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

DRUGPlacebo

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

Sponsors

Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Hs-Troponin-Iwithin 24 hours after CABGhigh sensitive cardiac troponin-I

Secondary

MeasureTime frame
Post operative occurrence of arrhythmiaswithin 24 hours after CABG
Duration of inotropic supportwithin two days after CABG
Time to detubationwithin two days after CABG
Post-ischemic recovery of contractile function of atrial trabeculaeuntil 4 hours after harvesting

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026