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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01438723
First received: September 21, 2011
Last updated: April 26, 2013
Last verified: November 2011

September 21, 2011
April 26, 2013
November 2011
July 2013   (final data collection date for primary outcome measure)
Hs-Troponin-I [ Time Frame: within 72 hours after CABG ] [ Designated as safety issue: No ]
high sensitive cardiac troponin-I
Same as current
Complete list of historical versions of study NCT01438723 on ClinicalTrials.gov Archive Site
  • Post operative occurrence of arrhythmias [ Time Frame: within 24 hours after CABG ] [ Designated as safety issue: No ]
  • Duration of inotropic support [ Time Frame: within three days after CABG ] [ Designated as safety issue: No ]
  • Time to detubation [ Time Frame: within three days after CABG ] [ Designated as safety issue: No ]
  • Post-ischemic recovery of contractile function of atrial trabeculae [ Time Frame: until 4 hours after harvesting ] [ Designated as safety issue: No ]
  • renal ischemia-reperfusion injury [ Time Frame: within three days after CABG ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Metformin in Coronary Artery Bypass Graft (CABG) (MetCAB) Trial
The Metformin in 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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Cardiovascular Disease
  • Ischemic Heart Disease
  • Drug: Metformin
    prior to CAGB surgery 3 day treatment with metformin 500 mg three times a day
    Other Name: Glucophage
  • Drug: Placebo
    prior to CABG surgery 3 day treatment with placebo capsules three times a day
  • Experimental: metformin
    Intervention: Drug: Metformin
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
Riksen NP, el Messaoudi S, Rongen GA. It takes more than one CAMERA to study cardiovascular protection by metformin. Lancet Diabetes Endocrinol. 2014 Feb;2(2):105-6. doi: 10.1016/S2213-8587(13)70207-9. Epub 2014 Feb 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
December 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: S El Messaoudi, MD MSc +31 24 3616723 S.ElMessaoudi@cardio.umcn.nl
Contact: N Riksen, MD PhD +31 24 3610614 N.Riksen@aig.umcn.nl
Netherlands
 
NCT01438723
MetCAB, 2011-000099-33
Yes
Radboud University
Radboud University
Not Provided
Not Provided
Radboud University
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP