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

NCT ID: NCT00979758

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2016-06-30

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

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 multiple biological activities independent of cholesterol-lowering action.This study is performed to find out more information about the strategy with Atorvastatin therapy to improve the survival of implanted cells. autologous bone marrow stem cells transplantation. Patients between 30 and 80 years of age who receive autologous bone marrow stem cell transplant at the Fuwai cardiovascular hospital may be eligible for this study. These patients receive autologous bone marrow cells transplantation intracoronary undergoing Percutaneous Coronary Intervention with regular or high dose of Atorvastatin treatment. The objective evaluations will be performed at baseline and during 12 months follow-up.

Heart function tests may include the following:

1. Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes placed on the chest transmit information from the heart to a machine.

2. Echocardiogram (Echo) is an ultrasound test that uses sound waves to create an image of the heart and examine the function of the heart chambers and valves.

3. Gated acquisition scan is a nuclear medicine test that uses a small amount of radioactive chemical injected into a vein. A special scanner creates an image of the heart for examining the beating motion of the muscle.

4. MRI evaluates function of the heart chambers the beating motion of the muscle.

Conditions

Myocardial Infarction; Stem Cell Transplantation; Angioplasty, Transluminal, Percutaneous Coronary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Atorvastatin

Atorvastatin routine dose

Group Type: SHAM_COMPARATOR

Atorvastatin and mononuclear cells transplantation

Intervention Type: DRUG

Routine or intensive dose of Atorvastatin therapy and mononuclear cells transplantation

Intensive Atorvastatin

Atorvastatin Intensive dose

Group Type: PLACEBO_COMPARATOR

Atorvastatin and mononuclear cells transplantation

Intervention Type: DRUG

Routine or intensive dose of Atorvastatin therapy and mononuclear cells transplantation

Atorvastatin+Transplantation

Atorvastatin routine dose+ Mononuclear cells Transplantation

Group Type: ACTIVE_COMPARATOR

Atorvastatin and mononuclear cells transplantation

Intervention Type: DRUG

Routine or intensive dose of Atorvastatin therapy and mononuclear cells transplantation

Intensive Atorvastatin+Transplantation

Atorvastatin intensive dose+ Mononuclear cells Transplantation

Group Type: EXPERIMENTAL

Atorvastatin and mononuclear cells transplantation

Intervention Type: DRUG

Routine or intensive dose of Atorvastatin therapy and mononuclear cells transplantation

Interventions

Atorvastatin and mononuclear cells transplantation

Routine or intensive dose of Atorvastatin therapy and mononuclear cells transplantation

Intervention Type: DRUG

Other Intervention Names

Statin; Bone marrow stem cells transplantation

Eligibility 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

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yuejin Yang

Vice president of Fuwai hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yang yuejin, Doctor

Role: STUDY_DIRECTOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

Fuwai Hospital

Beijing, , China

Countries

China

References

Yang YJ, Qian HY, Song L, Geng YJ, Gao RL, Li N, Wang H, Tian XQ, Huang J, Huang PS, Xu J, Shen R, Lu MJ, Zhao SH, Wu WC, Wu Y, Zhang J, Qian J, Xu JY, Xiong YY. Strengthening effects of bone marrow mononuclear cells with intensive atorvastatin in acute myocardial infarction. Open Heart. 2020 May;7(1):e001139. doi: 10.1136/openhrt-2019-001139.

Reference Type: DERIVED

PMID: 32393654 (View on PubMed)

Other Identifiers

Fuwai Hospital 2009

Identifier Type: -

Identifier Source: org_study_id