ESTIMATION Study for Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction

Study Overview
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Brief Summary
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The investigators hypothesised that endocardial stem cells implantation following after percutaneous coronary intervention (PCI) could reduce the scar formation and increase reverse remodeling in patients with primary acute myocardial infarction.

Official Title
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Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction

Conditions
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Acute Myocardial Infarction, Heart Failure

Intervention / Treatment
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* Procedure: PCI and Stem Cells or Placebo injections


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute Q-wave myocardial infarction after thrombolitic therapy during 6-36 hours from the onsent of signs Oclusion or significant stenosis of infarct-related left anterior descending artery (LAD) Left ventricle ejection fraction (LVEF) < 50% measured by Echo Exclusion Criteria: Thrombolysis of pyrrolase or streptokinase Surgical unsignificant stenosis of LAD Indications for CABG Cardiogenic shock Uncontrolled hypertension Thrombocytopenia Ongoing bleeding Anemia < 100 g/l Oncology Patients, who required anticoagulation therapy at the time of inclusion Obesity, BMI>40 Severe comorbidities Unwillingness to participate

Ages Eligible for Study
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Minimum Age: 30 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 (PCI+SC implantation)<br>Endocardial Stem cells implantation with Noga system | Procedure: PCI and Stem Cells or Placebo injections<br>* Conventional percutaneous coronary intervention after acute myocardial infarction. Harvest of bone marrow from iliac crest. Mesenchymal autologous stem cells preparation (7-10 days after PCI). LV mapping with Noga system (7-10 days after PCI). Randomization 1:1. Stem Cells or placebo implantation.<br>|
| Placebo Comparator: Group 2 (PCI+Placebo)<br>Placebo | Procedure: PCI and Stem Cells or Placebo injections<br>* Conventional percutaneous coronary intervention after acute myocardial infarction. Harvest of bone marrow from iliac crest. Mesenchymal autologous stem cells preparation (7-10 days after PCI). LV mapping with Noga system (7-10 days after PCI). Randomization 1:1. Stem Cells or placebo implantation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in left ventricle systolic volume on 15% mesured by MRI |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death |  | 12 months | 
| number of patients with thromboembolic events | comparison the number of patients with thromboembolic events between two groups | 12 months | 
| number of heart failure hospitalizations |  | 12 months | 
| Distance during 6-minute walking test |  | 12 months | 
| number of patients with life-threatening arrhythmias |  | 12 months | 
| BNP level |  | 12 months | 
| SPECT and Echo data |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endocardial Stem Cells Injection, Percutaneous Coronary Intervention