Left Ventricular Dysfunction Clinical Trial
Official title:
A Prospective,Randomized, Placebo-Controlled Study of Intramyocardial Injection of Autologous Bone-Marrow Mononuclear Cells in Patients With Severe, Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery
This prospective, randomized, placebo-controlled study was designed to assess the safety, feasibility and efficacy of intramyocardial injection of autologous bone marrow mononuclear cells in patients with severe, chronic ischemic disease scheduled to coronary artery bypass surgery.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Age between 18 and 75 years. 2. Scheduled to undergo CABG. 3. At least 3 months since last episode of myocardial infarction. 4. Echocardiogram-assessed LVEF between 15 and 40% (Simpson's rule). 5. Abnormal wall motion of at least one segment due to prior myocardial infarction shown by echocardiography or left ventriculography. 6. Abnormal myocardial perfusion in infarcted area by SPECT. 7. Willingness to participate and ability to provide written informed consent. Exclusion Criteria: 1. Contraindications to magnetic resonance imaging. 2. Need for urgent or emergent revascularization. 3. Severe valvular heart disease. 4. Confirmed myocardial infarction within 14 days, and/or rising cardiac biomarker proteins (i.e. troponin), and/or worsening ECG changes. 5. Prior cardiac surgery. 6. Stroke within 3 months prior to CABG. 7. Immunosuppressive medication (e.g. prednisone, cyclophosphamide, etanercept, etc.) 8. Severe chronic renal insufficiency (serum creatinine = 200 mmol/dl or need for dialysis), liver disease, (diagnosis of cirrhosis, chronic hepatitis, or elevation of serum transaminases =3 times the upper limit of normal), cerebrovascular disease requiring concomitant carotid endarterectomy, peripheral arterial disease (claudication as the primary factor limiting activity), active non-dermatological malignancy requiring on-going treatment, or any other condition that would place the patient at increased risk for complications in the judgment of the attending cardiologist or cardiac surgeon 9. Hemoglobin less than 10g/dL, white blood cell count less than 4,000/mm3, absolute neutrophil count less than 1500/mm3 10. Active infection, with a temperature greater than 37.5°C within 48 hrs prior to surgery and an unexplained white blood cell count in excess of 10,000/mm3 11. Significant cognitive impairment. 12. Any condition associated with a life expectancy of less than 6 months. 13. Participation in other studies. 14. Positive laboratory test results for HIV, HBC, and HCV. 15. Pregnant woman. 16. Inability or unwillingness to provide written informed consent. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Chinese PLA General Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese PLA General Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | major adverse cardiac events | Freedom from Major Adverse Cardiac Event: cardiac death, myocardial infarction, repeat coronary bypass grafting or percutaneous intervention of bypassed artery | 6 months | Yes |
Secondary | left ventricular function | Globlal function,regional myocardial perfusion and function assessed by magnetic resonance iamge and echocardiogram | 6 months | No |
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