A Safety and Efficacy Study to Confirm the Cardioprotective Effects of MC-1 in Patients Undergoing High-Risk CABG
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|ClinicalTrials.gov Identifier: NCT00402506|
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : November 16, 2007
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Bypass Graft Surgery Myocardial Ischemia Reperfusion Injury||Drug: (MC-1) Pyridoxal 5'-phosphate||Phase 3|
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 approximately 467,000 CABG procedures were performed in 2003.
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 sensorimotor abnormalities associated with stroke.
MC-1 is a naturally occurring metabolite of vitamin B6. 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 cardioprotective effects of MC-1 compared to placebo in patients undergoing high-risk CABG surgery.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||MEND-CABG II: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Cardioprotective Effects of MC-1 in Patients Undergoing High-Risk CABG Surgery|
|Study Start Date :||November 2006|
|Actual Study Completion Date :||September 2007|
- combined incidence of cardiovascular death or nonfatal myocardial infarction on days up to and including post-operative day (POD) 30
- length of hospital stay for index hospitalization
- length of stay in intensive care unit (ICU) or coronary care unit (CCU) for index hospitalization
- incidence of cardiovascular death up to and including POD 90
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402506
|United States, North Carolina|
|Duke Clinical Research Institute|
|Durham, North Carolina, United States, 27705|
|Montreal Heart Institute|
|Montreal, Quebec, Canada, H1T 1C8|
|Principal Investigator:||Michel Carrier, MD||Montreal Heart Institute|
|Principal Investigator:||Robert A Harrington, MD||Duke Clinical Research Institute|