Stem Cells in Myocardial Infarction

Study Overview
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Brief Summary
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The purpose of this trial is to investigate the effect of treatment with granulocyte-colony stimulating factor (G-CSF) bone marrow stimulation on circulating stem cells' ability to develop new blood vessels in the myocardium after an acute myocardial infarction.

Detailed Description
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Intracoronary infusion of bone-marrow stem cells after a ST elevation myocardial infarction (STEMI) seems to improve cardiac function. An alternative strategy is increase of circulating stem cells by mobilisation from the bone marrow with Granulocyte-Colony Stimulating Factor (G-CSF). Objective: To determine the short-term (30 days) safety of G-CSF therapy after a STEMI treated with acute percutaneous coronary intervention (PCI). Methods: Patients with STEMI treated with PCI <12 hours after symptom onset were randomised (1:1) to G-CSF (10 μg/kg/d) or placebo for 6 days in a double-blind design. Other inclusion criteria: age 20-70 years, culprit lesion in a large coronary artery, and peak CKMB >100 microgram/L. Follow-up was done after 1, 5 and 6 months, with an angiogram at 5 months.

Official Title
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Bone Marrow Stimulation With G-CSF in Acute Myocardial Infarction,

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Granulocyte Colony Stimulating Factor G-CSF (Neupogen®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 20 and 70 years with STEMI were eligible if they had a successful PCI within 12 hours after onset of symptoms. The target lesion had to be located in the proximal section of the left anterior descending (LAD), left circumflex (LCX) or right coronary artery (RCA). Only patients with creatine kinase [CK]-MB >100 microgram/L or development of Q waves in the electrocardiogram were included. Exclusion Criteria: Ventricular arrhythmia after PCI requiring treatment Pregnancy Unprotected left main stem lesion History of prior myocardial infarction Diagnosed or suspected cancer New York Heart Association (NYHA) class 3-4 Known severe claustrophobia Significant stenosis in another coronary vessel than the acutely treated vessel, that might demand treatment with PCI or coronary artery bypass graft surgery (CABG) prior to the last follow-up exam.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Granulocyte Colony Stimulating Factor G-CSF (Neupogen®)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pre-specified primary endpoint is change in regional systolic wall thickening from day 1 to day 180 evaluated with cardiac magnetic resonance imaging (MRI) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ejection fraction, end-systolic and end-diastolic volumes, regional myocardial perfusion, and infarct size by MRI |  |  | 
| Change in regional myocardial function by tissue Doppler echocardiography |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ST-elevation myocardial infarction, granulocyte-colony stimulating factor angiogenesis, stem cells