Autologous Stem Cell Transplantation in Acute Myocardial Infarction

Study Overview
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Brief Summary
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Objectives Intracoronary transplantation of different cell populations have been used in acute myocardial infarction (AMI) with promising results. The primary objective of the ASTAMI study is to test whether intracoronary transplantation of autologous mononuclear bone marrow cells (mBMC) improve left ventricular ejection fraction (LVEF) after anterior wall AMI. Design The ASTAMI study is a randomized, controlled, prospective study. One hundred patients with acute anterior wall ST-elevation myocardial infarction (STEMI) treated with acute PCI are randomized in a 1:1 way to either intracoronary transplantation of autologous mBMC 5-8 days after PCI or to control. Left ventricular function, exercise capacity, biochemical status, functional class, quality of life and complications are validated at baseline and during a 12-month follow up.

Official Title
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Autologous Stem Cell Transplantation in Acute Myocardial Infarction

Conditions
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Acute Anterior Wall Myocardial Infarction

Intervention / Treatment
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* Genetic: Intracoronary aotologous stem cell transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: age 40-75 years anterior wall AMI with 120-720 minutes from onset of symptoms to PCI ST elevation on ECG according to WHO criteria angiographically significant stenosis on LAD proximal to the second diagonal branch successful PCI with stenting of culprit lesion hypokinetic, akinetic or dyskinetic segments assessed by echocardiography in a standard 16 segment model and CK-MB above 3 times upper reference value. Exclusion criteria: previous MI with established significant Q-waves on ECG cardiogenic shock permanent pacemaker or other contraindication to MRI stroke with significant sequela short life expectancy due to extra cardiac reason uncontrolled endocrinological disturbance HIV and/or HBV/HCV positive serology mental disorder or other condition which interferes with patient possibility to comply with the protocol.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: Intracoronary aotologous stem cell transplantation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whether intracoronary mBMC transplantation improve LVEF after AMI assessed by ECG-gated SPECT. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test whether mBMC treatment improve exercise capacity assessed by bicycle ergometry |  |  | 
| To test whether mBMC treatment improve quality of life assessed by the SF 36 formula |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial infarction, bone marrow cells, cell transplantation