Myocardial Ischemia Clinical Trial
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
The purpose of this study is to determine the effect of MC-1 on the combined incidence of cardiovascular death and nonfatal myocardial infarction (MI) up to and including 30 days following coronary artery bypass graft (CABG) surgery compared with placebo.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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