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Coronary Artery Bypass Graft SurgeryPhase 2NCT00157716

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

A Phase 2 study testing (MC-1) Pyridoxal-5'-phosphate in people with Coronary Artery Bypass Graft Surgery and Myocardial Ischemia, run by Medicure at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
(MC-1) Pyridoxal-5'-phosphate
How many people
900 participants
Where
2 sitesin 2 countries
Study dates
Apr 2004to Oct 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Duke University Medical Center

    Durham, North Carolina, 27710-7510

Other trials in United States

Canada1 site

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Cardiovascular and Cerebrovascular Effects of MC-1 in Patients Undergoing High-Risk Coronary Artery Bypass Graft (CABG) Surgery

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

Read the 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. Due to the high incidence of coronary artery disease worldwide, as well as the effectiveness of the surgical procedure, CABG surgery makes up one of the top ten most frequently performed procedures in North America and Europe. In the United States it is estimated that over 700,000 CABG procedures are performed per year.

Despite the benefits of CABG surgery, patients undergoing these procedures may also suffer serious adverse outcomes including operative mortality, myocardial infarction, unstable angina, ventricular failure, life-threatening arrhythmia, renal insufficiency, and stroke.

Some of the proposed causes of cardiovascular morbidity and mortality after CABG include perioperative ischemia, inadequate myocardial protection and reperfusion injury. The impact of these serious complications is significant. Incidence rates of death and MI following CABG surgery range from 5% to 12% depending on risk status. Results from large clinical trials have recently demonstrated the importance of neurologic deficits as a problematic outcome of CABG. These deficits include memory impairment, psychomotor, visuospatial, attention and language abilities as measured by neuropsychological testing as well as sensori-motor abnormalities associated with stroke.

MC-1 is a naturally occurring small molecule. Evidence from pre-clinical and clinical studies suggests that MC-1 protects the heart from ischemic damage and ischemia-reperfusion injury. This trial will assess the effects of MC-1 compared to placebo on cardiovascular and neurological events following CABG surgery.

Being tested
(MC-1) Pyridoxal-5'-phosphate
Keywords
Coronary, surgery, ischemia, reperfusion injury, cardiac, heart, neurological, cardiopulmonary bypass, cardioprotection
Medical subject headings
Myocardial Ischemia, Reperfusion Injury, Ischemia, Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • (MC-1) Pyridoxal-5'-phosphateDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined incidence of cardiovascular death, nonfatal myocardial infarction and nonfatal cerebral infarction on days up to and including post-operative day 30.

Secondary outcomes (9)

  1. Combined incidence of cardiovascular death, nonfatal myocardial infarction and nonfatal cerebral infarction up to and including post-operative day (POD) 90

  2. Incidence of cardiovascular death up to and including POD 4, POD 30, POD 90

  3. Incidence of nonfatal myocardial infarction up to and including POD 4, POD 30, POD 90

  4. Incidence of all cause morality up to and including POD 4, POD 30, POD 90

  5. Global disability as measured by the Modified Rankin scale at POD 30 and POD 90

  6. MMSE score at POD 30 and POD 90

  7. Among patients with a confirmed cerebral infarction, severity of stroke as measured by the National Institutes of Health Stroke Scale (NIHSS) at the time of stroke diagnosis and at subsequent study visits up to and including POD 90

  8. Psychometric testing results as measured by a short battery of tests at POD 4, POD 30 and POD 90 on a subset of approximately 150 volunteers per treatment arm

  9. CK-MB AUC (0-24 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startApr 2004
  3. Study completionOct 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
900 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00157716
Sponsor's protocol ID
MC6021-CR-03-02
Status last verified
Oct 2006
First submitted
8 Sep 2005
Last updated
31 Oct 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing (MC-1) Pyridoxal-5'-phosphate in people with Coronary Artery Bypass Graft Surgery and Myocardial Ischemia, run by Medicure at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined incidence of cardiovascular death, nonfatal myocardial infarction and nonfatal cerebral infarction on days up to and including post-operative day 30.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00157716.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2006; AzTrials last refreshed its copy on 7 Nov 2026.

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