Angioplasty, Transluminal, Percutaneous Coronary, Myocardial Infarction, Stem Cell Transplantation
Conditions
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.
Interventions
DRUGAtorvastatin and mononuclear cells transplantation
Routine or intensive dose of Atorvastatin therapy and mononuclear cells transplantation
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in left ventricular ejection fraction from baseline to 12 months' follow-up | 12 months |
Countries
China
Outcome results
None listed