MEND-CABG (MC-1 to Eliminate Necrosis and Damage in Coronary Artery Bypass Graft Surgery)
The purpose of this study is to determine whether MC-1 is effective and safe in reducing cardiovascular and neurological events in patients undergoing high-risk coronary artery bypass surgery
Coronary Artery Bypass Graft Surgery
Drug: (MC-1) Pyridoxal-5’-phosphate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Cardiovascular and Cerebrovascular Effects of MC-1 in Patients Undergoing High-Risk Coronary Artery Bypass Graft (CABG) Surgery|
- Combined incidence of cardiovascular death, nonfatal myocardial infarction and nonfatal cerebral infarction on days up to and including post-operative day 30.
- Combined incidence of cardiovascular death, nonfatal myocardial infarction and nonfatal cerebral infarction up to and including post-operative day (POD) 90
- Incidence of cardiovascular death up to and including POD 4, POD 30, POD 90
- Incidence of nonfatal myocardial infarction up to and including POD 4, POD 30, POD 90
- Incidence of all cause morality up to and including POD 4, POD 30, POD 90
- Global disability as measured by the Modified Rankin scale at POD 30 and POD 90
- MMSE score at POD 30 and POD 90
- Among patients with a confirmed cerebral infarction, severity of stroke as measured by the National Institutes of Health Stroke Scale (NIHSS) at the time of stroke diagnosis and at subsequent study visits up to and including POD 90
- Psychometric testing results as measured by a short battery of tests at POD 4, POD 30 and POD 90 on a subset of approximately 150 volunteers per treatment arm
- CK-MB AUC (0-24 hours)
|Study Start Date:||April 2004|
|Estimated Study Completion Date:||October 2005|
Coronary artery bypass grafting (CABG) effectively relieves angina, results in longer survival, and a better quality of life in specific subgroups of patients with obstructive coronary artery disease. Due to the high incidence of coronary artery disease worldwide, as well as the effectiveness of the surgical procedure, CABG surgery makes up one of the top ten most frequently performed procedures in North America and Europe. In the United States it is estimated that over 700,000 CABG procedures are performed per year.
Despite the benefits of CABG surgery, patients undergoing these procedures may also suffer serious adverse outcomes including operative mortality, myocardial infarction, unstable angina, ventricular failure, life-threatening arrhythmia, renal insufficiency, and stroke.
Some of the proposed causes of cardiovascular morbidity and mortality after CABG include perioperative ischemia, inadequate myocardial protection and reperfusion injury. The impact of these serious complications is significant. Incidence rates of death and MI following CABG surgery range from 5% to 12% depending on risk status. Results from large clinical trials have recently demonstrated the importance of neurologic deficits as a problematic outcome of CABG. These deficits include memory impairment, psychomotor, visuospatial, attention and language abilities as measured by neuropsychological testing as well as sensori-motor abnormalities associated with stroke.
MC-1 is a naturally occurring small molecule. Evidence from pre-clinical and clinical studies suggests that MC-1 protects the heart from ischemic damage and ischemia-reperfusion injury. This trial will assess the effects of MC-1 compared to placebo on cardiovascular and neurological events following CABG surgery.
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710-7510|
|Montreal Heart Institute|
|Montreal, Quebec, Canada, H1T 1C8|
|Principal Investigator:||Jean-Claude Tardif, MD, FRCPC, FACC||Montreal Heart Institute Research Centre|