Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00157716
Status:
COMPLETED
Last Update Posted:
2006-10-31
First Post:
2005-09-08
Brief Title:
MEND-CABG MC-1 to Eliminate Necrosis and Damage in Coronary Artery Bypass Graft Surgery
Sponsor:
Medicure
Organization:
Medicure
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 700000 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None