Status:
COMPLETED
MEND-CABG (MC-1 to Eliminate Necrosis and Damage in Coronary Artery Bypass Graft Surgery)
Lead Sponsor:
Medicure
Conditions:
Coronary Artery Bypass Graft Surgery
Myocardial Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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....
Eligibility Criteria
Inclusion
- 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:
- Age \>65
- Current smoker
- History of diabetes mellitus requiring treatment other than diet
- Evidence of left ventricular dysfunction or congestive heart failure assessed by: ejection fraction (EF) \<45%, left ventricular end diastolic pressure (LVEDP) or pulmonary wedge pressure greater than or equal to 20 mm Hg, pulmonary edema by chest X-ray, cardiothoracic ratio \>50% on chest X-ray
- History of a previous non-disabling stroke, transient ischemic attack, or carotid endarterectomy
- Urgent CABG intervention defined as the need to stay in the hospital (although patient may be operated on within a normal scheduling routine
- History of a myocardial infarction that occurred more than 48 hours but less than 6 weeks prior to CABG surgery
- Prior peripheral artery surgery or angioplasty
- Moderate renal dysfunction defined by creatinine ≥ 133 micromol/L (1.5 mg/dL), but \< 250 micromol/L (2.8 mg/dL)
- Presence of at least one asymptomatic carotid artery stenosis (≥50%) either in one or two carotid arteries
Exclusion
- Planned associated valve surgery or concurrent carotid endarterectomy
- Planned aortic dissection repair or aortic root reconstruction
- Screening visit occurring less than 4 hours before scheduled CABG surgery
- MMSE score less than 24 at the screening visit
- Current cardiogenic shock, acute left ventricular rupture, ventricular septal rupture, or papillary muscle rupture
- Uncontrolled diabetes defined as fasting serum blood glucose value equal to or greater than 24 mmol/L (432 mg/dL) at the time of screening (if fasting serum blood glucose not obtained at screening, values obtained within 30 days prior to screening visit may be used)
- Myocardial infarction occurring \<48 hours prior to planned CABG surgery
- Severe renal dysfunction defined as a serum creatinine value ≥ 250 micromol/L (2.8 mg/dL) or nephritic syndrome at screening (or obtained within 30 days prior to screening visit)
- History of liver cirrhosis, chronic active hepatitis, or severe liver dysfunction , or liver transaminase ≥3 times ULN at screening (or obtained within 30 days prior to screening visit)
- History of malignancy during last 5 years except for basal cell carcinoma
- Planned surgery for atrial fibrillation
- Pregnancy or potential for pregnancy
- Any medical or psychiatric condition which in the opinion of the investigator makes the patient an unsuitable candidate for the study
- History of alcohol or drug abuse within the past year
- Participation in any other investigation drug or device study within 30 days of randomization
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT00157716
Start Date
April 1 2004
End Date
October 1 2005
Last Update
October 31 2006
Active Locations (2)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710-7510
2
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8