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 range
18 Years
Sex
ALL
See this in plain English?
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.