MEND-CABG (MC-1 to Eliminate Necrosis and Damage in Coronary Artery Bypass Graft Surgery) (NCT00157716) | Clinical Trial Compass
CompletedPhase 2
MEND-CABG (MC-1 to Eliminate Necrosis and Damage in Coronary Artery Bypass Graft Surgery)
United States, Canada900 participantsStarted 2004-04
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Combined incidence of cardiovascular death, nonfatal myocardial infarction and nonfatal cerebral infarction on days up to and including post-operative day 30.