Strengthening Transplantation Effects of Bone Marrow Mononuclear Cells With Atorvastatin in Myocardial Infarction (STEM-AMI)

January 23, 2018 updated by: Yuejin Yang, Chinese Academy of Medical Sciences, Fuwai Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100037
        • Fuwai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Atorvastatin
Atorvastatin routine dose
Drug: Atorvastatin and mononuclear cells transplantation
Routine or intensive dose of Atorvastatin therapy and mononuclear cells transplantation
Other Names:
  • Statin
  • Bone marrow stem cells transplantation
PLACEBO_COMPARATOR: Intensive Atorvastatin
Atorvastatin Intensive dose
Drug: Atorvastatin and mononuclear cells transplantation
Routine or intensive dose of Atorvastatin therapy and mononuclear cells transplantation
Other Names:
  • Statin
  • Bone marrow stem cells transplantation
ACTIVE_COMPARATOR: Atorvastatin+Transplantation
Atorvastatin routine dose+ Mononuclear cells Transplantation
Drug: Atorvastatin and mononuclear cells transplantation
Routine or intensive dose of Atorvastatin therapy and mononuclear cells transplantation
Other Names:
  • Statin
  • Bone marrow stem cells transplantation
EXPERIMENTAL: Intensive Atorvastatin+Transplantation
Atorvastatin intensive dose+ Mononuclear cells Transplantation
Drug: Atorvastatin and mononuclear cells transplantation
Routine or intensive dose of Atorvastatin therapy and mononuclear cells transplantation
Other Names:
  • Statin
  • Bone marrow stem cells transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in left ventricular ejection fraction from baseline to 12 months' follow-up
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

  • Study Director: Yang yuejin, Doctor, Fuwai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2009

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

September 17, 2009

First Submitted That Met QC Criteria

September 17, 2009

First Posted (ESTIMATE)

September 18, 2009

Study Record Updates

Last Update Posted (ACTUAL)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fuwai Hospital 2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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