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

Completed · Phase 2

Conditions studied: Coronary Artery Bypass Graft Surgery, Myocardial Ischemia, Reperfusion Injury, Myocardial Revascularization

In brief

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

Key facts

Study ID

NCT00157716

Run by

Medicure

People needed

900

Starts

2004-04-01

Expected to finish

2005-10-01

Last updated by the study team

2006-10-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States
• Montreal Heart Institute — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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