Myocardial Ischemia Clinical Trial
Official title:
MEND-CABG II: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Cardioprotective Effects of MC-1 in Patients Undergoing High-Risk CABG Surgery
The purpose of this study is to determine the effect of MC-1 on the combined incidence of cardiovascular death and nonfatal myocardial infarction (MI) up to and including 30 days following coronary artery bypass graft (CABG) surgery compared with placebo.
Status | Completed |
Enrollment | 3000 |
Est. completion date | September 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients must be scheduled to undergo CABG surgery (during routine scheduling times) and had planned to use cardiopulmonary bypass. - Provide informed consent - Age = 18 - Male patients, or female patients not of childbearing potential or who have had a negative pregnancy test and are practicing adequate contraception - Patients must be considered at high risk for subsequent myocardial complications defined as meeting 2 or more of the following: - Age = 65 - Current or recent smoker (within last 6 months) - 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 (PWP) = 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 as creatinine clearance = 30 ml/min, but < 60 ml/min - 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 less than 4 hours before scheduled CABG surgery - Mini-Mental State Examination (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 an estimated creatinine clearance value of < 30 ml/min or nephrotic syndrome at screening (or measured creatinine clearance value obtained within 30 days prior to screening visit) - History of liver cirrhosis, chronic active hepatitis (known positive serum test within 6 months of enrolment), or severe liver dysfunction; or liver transaminase = 3 times upper limit of normal (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 - Planned associated transmyocardial revascularization - Planned associated ventricular remodeling - 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 - Significant, ongoing alcohol or drug abuse - Participation in any other investigational drug or device study within 30 days of randomization |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Montreal Heart Institute | Montreal | Quebec |
United States | Duke Clinical Research Institute | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Medicure |
United States, Canada,
Kandzari DE, Labinaz M, Cantor WJ, Madan M, Gallup DS, Hasselblad V, Joseph D, Allen A, Green C, Hidinger KG, Krucoff MW, Christenson RH, Harrington RA, Tcheng JE. Reduction of myocardial ischemic injury following coronary intervention (the MC-1 to Eliminate Necrosis and Damage trial). Am J Cardiol. 2003 Sep 15;92(6):660-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | combined incidence of cardiovascular death or nonfatal myocardial infarction on days up to and including post-operative day (POD) 30 | |||
Secondary | length of hospital stay for index hospitalization | |||
Secondary | length of stay in intensive care unit (ICU) or coronary care unit (CCU) for index hospitalization | |||
Secondary | incidence of cardiovascular death up to and including POD 90 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
Completed |
NCT04153006 -
Comparison of Fingerstick Versus Venous Sample for Troponin I.
|
||
Completed |
NCT01205776 -
EXCEL Clinical Trial
|
N/A | |
Active, not recruiting |
NCT04555174 -
BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry
|
||
Recruiting |
NCT04582877 -
Pressure Guidewire System Multi-center, Prospective, Self-Control, Clinical Trial
|
N/A | |
Recruiting |
NCT04390672 -
Multivessel TALENT
|
N/A | |
Recruiting |
NCT03265535 -
Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging
|
||
Not yet recruiting |
NCT04522583 -
Increased CRP Concentrations in Patients Admitted to the Emergency Department With Troponin Elevation Aids to Rule Out Coronary Ischemia
|
||
Completed |
NCT02554006 -
Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings
|
N/A | |
Terminated |
NCT02407626 -
Optimization of Cardioprotection in Diabetic Patients Undergoing Cardiac Surgery
|
N/A | |
Completed |
NCT02510547 -
Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial
|
Phase 4 | |
Active, not recruiting |
NCT02189499 -
Feasibility Study of the Amaranth Medical FORTITUDE Bioresorbable Drug-Eluting Coronary Stent
|
Phase 2 | |
Completed |
NCT02197065 -
Pilot Study of Atorvastatin for Orthopedic Surgery Patients
|
Phase 2 | |
Completed |
NCT02264717 -
Dan-NICAD - Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease
|
N/A | |
Recruiting |
NCT01681381 -
Evaluate Safety And Effectiveness Of The Tivoli® DES and The Firebird2® DES For Treatment Coronary Revascularization
|
N/A | |
Completed |
NCT01655043 -
Absolute Quantification of Coronary Flow Reserve by Stress Perfusion MRI
|
Phase 2 | |
Terminated |
NCT01892917 -
BIOFLOW-III Hungary Satellite Registry
|
N/A | |
Completed |
NCT01679886 -
Comparison of Rubidium PET and SPECT With CZT Crystals for Detection of Myocardial Ischemia in Overweighed Patients and Women
|
N/A | |
Completed |
NCT01434043 -
Diagnostic Accuracy of Cardiac CT Perfusion Compared to PET Imaging
|