Bone Marrow Stem Cell Mobilisation Therapy for Acute Myocardial Infarction (AMI)(REVIVAL-2)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether stem cell mobilization by granulocyte colony-stimulating factor (G-CSF) therapy in patients with acute myocardial infarction after successful mechanical reperfusion reduces infarct size.

Detailed Description
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Experimental studies and early-phase clinical trials suggest that transplantation of blood-derived or bone marrow-derived progenitor cells may improve cardiac regeneration after acute myocardial infarction. Granulocyte colony-stimulating factor (G-CSF) induces mobilization of bone marrow stem cells and, thereby, increases the number of circulating stem cells that are available cells for myocardial regeneration.

Official Title
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A Randomized Clinical Trial of Stem Cell Mobilization by Granulocyte-Colony-Stimulating Factor in Patients With Acute Myocardial Infarction. Regenerate Vital Myocardium by Vigorous Activation of Bone Marrow Stem Cells (REVIVAL-2) Trial

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: G-CSF Granulocyte-Colony Stimulating Factor
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ST-elevation acute myocardial infarction (5 days before randomization) Successful percutaneous coronary intervention [PCI] (performed within 12 hours from symptom onset) Scintigraphic infarct size >5% of left ventricle Written informed consent Exclusion Criteria: Age <18 years or >80 years Congestive heart failure defined as Killip class >2 A history of myocardial infarction Electrical or hemodynamic instability Autoimmune diseases Fructose intolerance Malignancies Incompatibility of filgrastim Known or suspected pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients were randomly assigned to receive subcutaneously a daily dose of 10 microg/kg of G-CSF for 5 days. | Drug: G-CSF Granulocyte-Colony Stimulating Factor<br>* Patients were randomly assigned to receive subcutaneously a daily dose of 10 microg/kg of G-CSF for 5 days.<br>* Other names: Granocyte (Lenograstim);|
| Placebo Comparator: 2<br>Patients were randomly assigned to receive subcutaneously a daily dose of placebo for 5 days. | Other: Placebo<br>* Patients were randomly assigned to receive subcutaneously either a daily dose of 10 microg/kg of G-CSF or placebo for 5 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of infarct size (measured by Tc-sestamibi scintigraphy) |  | measured by Tc-sestamibi scintigraphy baseline, 4 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction |  | Left ventricular ejection fraction | 
| Incidence of angiographic restenosis |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem Cells