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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01438723
First received: September 21, 2011
Last updated: July 28, 2014
Last verified: November 2011
  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


Condition Intervention Phase
Cardiovascular Disease
Ischemic Heart Disease
Drug: Metformin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Metformin in CABG (MetCAB) Trial

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Hs-Troponin-I [ Time Frame: within 24 hours after CABG ] [ Designated as safety issue: No ]
    high sensitive cardiac troponin-I


Secondary Outcome Measures:
  • Post operative occurrence of arrhythmias [ Time Frame: within 24 hours after CABG ] [ Designated as safety issue: No ]
  • Duration of inotropic support [ Time Frame: within two days after CABG ] [ Designated as safety issue: No ]
  • Time to detubation [ Time Frame: within two 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 ]

Enrollment: 100
Study Start Date: November 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438723

Locations
Netherlands
RUNMC
Nijmegen, Gelderland, Netherlands
Sponsors and Collaborators
Radboud University
  More Information

No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01438723     History of Changes
Other Study ID Numbers: MetCAB, 2011-000099-33
Study First Received: September 21, 2011
Last Updated: July 28, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
ischemia reperfusion injury
CABG
metformin
Hs-troponin-I

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

ClinicalTrials.gov processed this record on September 18, 2014