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Completed

NCT Number: NCT00979758

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

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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fuwai Hospital

Beijing, 100037, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atorvastatin and mononuclear cells transplantation

Drug

Routine or intensive dose of Atorvastatin therapy and mononuclear cells transplantation

Other names: Statin, Bone marrow stem cells transplantation

Primary outcomes

  1. Changes in left ventricular ejection fraction from baseline to 12 months' follow-up

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Acronym: STEM-AMI

Important dates

Study start
2009
Primary completion
2015
Study completion
2016
First posted
Sep 18, 2009
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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