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:
- Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes placed on the chest transmit information from the heart to a machine.
- 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.
- 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.
- 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
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Beijing, China, 100037
- Fuwai Hospital
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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:
- 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 Criteria:
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.
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
|
Routine or intensive dose of Atorvastatin therapy and mononuclear cells transplantation
Other Names:
|
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PLACEBO_COMPARATOR: Intensive Atorvastatin
Atorvastatin Intensive dose
|
Routine or intensive dose of Atorvastatin therapy and mononuclear cells transplantation
Other Names:
|
|
ACTIVE_COMPARATOR: Atorvastatin+Transplantation
Atorvastatin routine dose+ Mononuclear cells Transplantation
|
Routine or intensive dose of Atorvastatin therapy and mononuclear cells transplantation
Other Names:
|
|
EXPERIMENTAL: Intensive Atorvastatin+Transplantation
Atorvastatin intensive dose+ Mononuclear cells Transplantation
|
Routine or intensive dose of Atorvastatin therapy and mononuclear cells transplantation
Other Names:
|
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.
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.
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
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Myocardial Infarction
- Infarction
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
Other Study ID Numbers
- Fuwai Hospital 2009
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