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

NCT00157716 | Completed Phase 2

• 1 other identifier: MC6021-CR-03-02
• Study Type: interventional
• Target: 900
• Locations: 2 countries
• Sites: 2

Brief 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

Conditions

Coronary Artery Bypass Graft Surgery; Myocardial Ischemia; Reperfusion Injury; Myocardial Revascularization

Keywords

Coronary; surgery; ischemia; reperfusion injury; cardiac; heart; neurological; cardiopulmonary bypass; cardioprotection

Outcome Measures

Primary Outcomes (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)

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

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

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

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

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

Interventions

(MC-1) Pyridoxal-5'-phosphate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Medicure: lead

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27710-7510, United States

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

MeSH Terms

Conditions

Myocardial Ischemia; Reperfusion Injury; Ischemia; Neurologic Manifestations

Interventions

Pyridoxal Phosphate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridoxal; Vitamin B 6; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes

Study Officials

• Jean-Claude Tardif, MD, FRCPC, FACC

  Montreal Heart Institute Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: April 1, 2004
• Study Completion: October 1, 2005
• Last Updated: October 31, 2006

Record last verified: 2006-10

Locations

US (1); CA (1)