Status:
COMPLETED
Strengthening Transplantation Effects of Bone Marrow Mononuclear Cells With Atorvastatin in Myocardial Infarction
Lead Sponsor:
Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions:
Myocardial Infarction
Stem Cell Transplantation
Eligibility:
All Genders
30-80 years
Phase:
PHASE2
Brief Summary
The benefit of current stem cell transplantation therapy for myocardial infarction is limited by low survival rate for stem cell. The purpose of this study is to test whether intensive Atorvastatin th...
Detailed Description
The major challenge to a successful stem cell therapy for myocardial infarction is the low survival rate of implanted cells in the damaged tissue. Atorvastatin, an HMG-CoA reductase inhibitor, has mul...
Eligibility Criteria
Inclusion
- Patients with coronary disease undergoing PCI.
- At most 2 months since last episode of ST-elevation myocardial infarction.
- Left ventricular ejection fraction \>=20% \<=45% based on coronary angiography or echocardiography.
Exclusion
- Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.
- Patients with non-ST-elevation myocardial infarction.
- Patients with normal left ventricular function.
- Patients with mechanical complications of myocardial infarction.
- Patients with a malignant tumor.
- Patients with infection disease.
- Less than 6 months since last episode of stroke.
- Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
- AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.
- Leukocytes less than 4,000/µL or exceeding 10,000/µL.
- Platelets less than 100,000/µL.
- Hemoglobin less than 10 g/dL.
- Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
- Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00979758
Start Date
January 1 2009
End Date
June 1 2016
Last Update
January 25 2018
Active Locations (1)
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1
Fuwai Hospital
Beijing, China, 100037