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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier:
NCT00979758
First received: September 17, 2009
Last updated: April 19, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Stem Cell Transplantation
Angioplasty, Transluminal, Percutaneous Coronary
Drug: Atorvastatin and mononuclear cells transplantation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Strengthening Transplantation Effects of Bone Marrow Mononuclear Cells With Atorvastatin in Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Cardiovascular Institute & Fuwai Hospital:

Primary Outcome Measures:
  • Changes in left ventricular ejection fraction from baseline to 12 months' follow-up [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active 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
Active 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

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.
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979758

Locations
China
Fuwai Hospital
Beijing, China, 100037
Sponsors and Collaborators
Cardiovascular Institute & Fuwai Hospital
Investigators
Study Director: Yang yuejin, Doctor Fuwai Hospital
  More Information

No publications provided

Responsible Party: Yang yuejin, Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier: NCT00979758     History of Changes
Other Study ID Numbers: Fuwai Hospital 2009
Study First Received: September 17, 2009
Last Updated: April 19, 2011
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014