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Sponsored by: |
Medicure |
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Information provided by: | Medicure |
ClinicalTrials.gov Identifier: | NCT00157716 |
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
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Bypass Graft Surgery Myocardial Ischemia Reperfusion Injury Myocardial Revascularization |
Drug: (MC-1) Pyridoxal-5’-phosphate |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 900 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must be scheduled to undergo CABG surgery (during routine scheduling times) planned to use cardiopulmonary bypass
Patients must be considered at high risk for subsequent neurological or myocardial complications defined as meeting 2 or more of the following:
Exclusion Criteria:
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710-7510 | |
Canada, Quebec | |
Montreal Heart Institute | |
Montreal, Quebec, Canada, H1T 1C8 |
Principal Investigator: | Jean-Claude Tardif, MD, FRCPC, FACC | Montreal Heart Institute Research Centre |
Study ID Numbers: | MC6021-CR-03-02 |
Study First Received: | September 8, 2005 |
Last Updated: | October 30, 2006 |
ClinicalTrials.gov Identifier: | NCT00157716 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Coronary surgery ischemia reperfusion injury cardiac |
heart neurological cardiopulmonary bypass cardioprotection |
Pyridoxal Phosphate Heart Diseases Vitamin B Complex Myocardial Ischemia Vascular Diseases Trace Elements Ischemia |
Necrosis Postoperative Complications Pyridoxal Vitamins Pyridoxine Micronutrients Reperfusion Injury |
Pyridoxal Phosphate Heart Diseases Vitamin B Complex Myocardial Ischemia Growth Substances Physiological Effects of Drugs Vascular Diseases Ischemia |
Pharmacologic Actions Pathologic Processes Postoperative Complications Vitamins Cardiovascular Diseases Micronutrients Reperfusion Injury |