MEND-CABG (MC-1 to Eliminate Necrosis and Damage in Coronary Artery Bypass Graft Surgery)

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medicure
• Treatments: Pyridoxal; Pyridoxal Phosphate

Criteria

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:

• 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 Criteria:

• 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