The Metformin in Coronary Artery Bypass Graft (CABG) (MetCAB) Trial (MetCAB)
Primary Purpose
Cardiovascular Disease, Ischemic Heart Disease
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Metformin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Disease focused on measuring ischemia reperfusion injury, CABG, metformin, Hs-troponin-I
Eligibility 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
Sites / Locations
- RUNMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
metformin
placebo
Arm Description
Outcomes
Primary Outcome Measures
Hs-Troponin-I
high sensitive cardiac troponin-I
Secondary Outcome Measures
Post operative occurrence of arrhythmias
Duration of inotropic support
Time to detubation
Post-ischemic recovery of contractile function of atrial trabeculae
Full Information
NCT ID
NCT01438723
First Posted
September 21, 2011
Last Updated
July 28, 2014
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01438723
Brief Title
The Metformin in Coronary Artery Bypass Graft (CABG) (MetCAB) Trial
Acronym
MetCAB
Official Title
The Metformin in CABG (MetCAB) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Ischemic Heart Disease
Keywords
ischemia reperfusion injury, CABG, metformin, Hs-troponin-I
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
metformin
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Glucophage
Intervention Description
prior to CAGB surgery 3 day treatment with metformin 500 mg three times a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
prior to CABG surgery 3 day treatment with placebo capsules three times a day
Primary Outcome Measure Information:
Title
Hs-Troponin-I
Description
high sensitive cardiac troponin-I
Time Frame
within 24 hours after CABG
Secondary Outcome Measure Information:
Title
Post operative occurrence of arrhythmias
Time Frame
within 24 hours after CABG
Title
Duration of inotropic support
Time Frame
within two days after CABG
Title
Time to detubation
Time Frame
within two days after CABG
Title
Post-ischemic recovery of contractile function of atrial trabeculae
Time Frame
until 4 hours after harvesting
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
RUNMC
City
Nijmegen
State/Province
Gelderland
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
26179504
Citation
El Messaoudi S, Nederlof R, Zuurbier CJ, van Swieten HA, Pickkers P, Noyez L, Dieker HJ, Coenen MJ, Donders AR, Vos A, Rongen GA, Riksen NP. Effect of metformin pretreatment on myocardial injury during coronary artery bypass surgery in patients without diabetes (MetCAB): a double-blind, randomised controlled trial. Lancet Diabetes Endocrinol. 2015 Aug;3(8):615-23. doi: 10.1016/S2213-8587(15)00121-7. Epub 2015 Jul 12.
Results Reference
derived
PubMed Identifier
24622709
Citation
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. No abstract available.
Results Reference
derived
Learn more about this trial
The Metformin in Coronary Artery Bypass Graft (CABG) (MetCAB) Trial
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