Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction (SCAMI)

Study Overview
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Brief Summary
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Autologous stem cells may improve myocardial regeneration after intracoronary administration in patients with acute myocardial infarction. The primary hypothesis of this prospective, placebo-controlled, double-blind trial is that the increase of ejection fraction determined by magnetic resonance imaging between baseline and 6 months follow-up is superior in active treated patients compared to patients receiving placebo. The study includes an integrated pilot phase of 40 patients for evaluation of left ventricular ejection fraction determined by cardiac magnetic resonance imaging. Based on the data of this analysis the final sample size will be calculated. The primary endpoint is the improvement in left ventricular ejection fraction with an assumed 2.5% higher improvement in the cell treated population compared to the placebo treated group.

Detailed Description
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There is a 2:1 randomization for bone marrow cell therapy versus placebo therapy. Patients will be stratified according to age, localization of myocardial infarction and left ventricular function.

Official Title
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Intracoronary Stem Cell Therapy in Patients With Acute Myocardial Infarction - A Randomized, Double-blind, Placebo Controlled Trial (SCAMI)

Conditions
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Acute Myocardial Infarction, Coronary Artery Disease

Intervention / Treatment
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* Other: autologous stem cells
* Other: placebo suspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute myocardial infarction with time to revascularization >6 hours from symptom start clear target vessel large myocardial infarction defined as: proximal vessel occlusion, CK > 1000 U/L, myocardial scar in magnetic resonance imaging > 10% of left ventricular muscle mass potential prior thrombolysis written informed consent Exclusion Criteria: acute myocardial infarction with revascularization within 6 hours after symptom start prior myocardial infarction no clear target vessel contraindication for magnetic resonance imaging (e.g. pacemaker, ICD) severely depressed left ventricular ejection fraction (less than 20% in magnetic resonance imaging) prior hematologic disease prior chemo therapy prior stem cell transplantation prior treatment with G-CSF known alteration of the bone marrow by alcohol or drugs, e.g. agranulocytosis local infection of puncture sites

Ages Eligible for Study
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Minimum Age: 35 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>autologous stem cells, Ficoll preparation, intracoronary administration at the same day of bone marrow cell aspiration | Other: autologous stem cells<br>* intracoronary administration at the same day of cell aspiration using the stop flow technique<br>|
| Placebo Comparator: 2<br>placebo is visually indistinguishable from verum due to integration of autologous erythrocytes, intracoronary administration the same day of bone marrow aspiration | Other: placebo suspension<br>* intracoronary administration at the same day as cell aspiration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in left ventricular ejection fraction measured by magnetic resonance imaging at baseline and 6 months follow-up |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular ejection fraction measured by magnetic resonance imaging |  | 1, 3, 12 months | 
| left ventricular enddiastolic volume measured by magnetic resonance imaging |  | 1, 3, 6, 12 months | 
| left ventricular endsystolic volume measured by magnetic resonance imaging |  | 1, 3, 6, 12 months | 
| major adverse cardiac events |  | 1, 3, 6, 12 months |