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

Cardiovascular Disease Clinical Trial

— MetCAB  

Official title:

The Metformin in CABG (MetCAB) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01438723
• Other study ID #: MetCAB
• Secondary ID: 2011-000099-33
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2011
• Last updated: July 28, 2014
• Start date: November 2011
• Est. completion date: July 2014

Study information

• Verified date: November 2011
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• Metformin
prior to CAGB surgery 3 day treatment with metformin 500 mg three times a day
• Placebo
prior to CABG surgery 3 day treatment with placebo capsules three times a day

Locations

Country	Name	City	State
Netherlands	RUNMC	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hs-Troponin-I	high sensitive cardiac troponin-I	within 24 hours after CABG	No
Secondary	Post operative occurrence of arrhythmias		within 24 hours after CABG	No
Secondary	Duration of inotropic support		within two days after CABG	No
Secondary	Time to detubation		within two days after CABG	No
Secondary	Post-ischemic recovery of contractile function of atrial trabeculae		until 4 hours after harvesting	No