Overview

Strengthening Transplantation Effects of Bone Marrow Mononuclear Cells With Atorvastatin in Myocardial Infarction

Status:
Completed

Trial end date:
2016-06-01

Target enrollment:
0

Participant gender:
All

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 therapy can improve the outcome of patients with impaired left ventricle function after myocardial infarction who underwent intracoronary transfer of autologous bone marrow cells.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Chinese Academy of Medical Sciences, Fuwai Hospital

Treatments:

Atorvastatin
Atorvastatin Calcium

Criteria

Inclusion Criteria:

1. Patients with coronary disease undergoing PCI.

2. At most 2 months since last episode of ST-elevation myocardial infarction.

3. Left ventricular ejection fraction >=20% <=45% based on coronary angiography or
echocardiography.

Exclusion Criteria:

Any one of the following exclusion criteria is sufficient to disqualify a patient from the
study.

1. Patients with non-ST-elevation myocardial infarction.

2. Patients with normal left ventricular function.

3. Patients with mechanical complications of myocardial infarction.

4. Patients with a malignant tumor.

5. Patients with infection disease.

6. Less than 6 months since last episode of stroke.

7. Patients with hematological disease (leukemia, myeloproliferative disease, or
myelodysplastic syndromes).

8. AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.

9. Leukocytes less than 4,000/µL or exceeding 10,000/µL.

10. Platelets less than 100,000/µL.

11. Hemoglobin less than 10 g/dL.

12. Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming
pregnant before the end of the study period.

13. Any other reason that the Clinical Supervisors or Clinical Researchers may have for
considering a case unsuitable for the study.