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| ID | Type | Description | Link |
|---|---|---|---|
| RU8HM86-54N | Other Identifier | State Research Institute of Circulation Pathology |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (PCI+SC implantation) | Active Comparator | Endocardial Stem cells implantation with Noga system |
|
| Group 2 (PCI+Placebo) | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCI and Stem Cells or Placebo injections | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in left ventricle systolic volume on 15% mesured by MRI | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evgeny Pokushalov, MD | Contact | +79139254858 | E.Pokushalov@gmail.com | |
| Alexander Romanov, MD | Contact | +79137172652 | abromanov@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Evgeny A Pokushalov, MD, PhD | State Research Institute of Circulation Pathology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Research Institute of Circulation Pathology | Recruiting | Novosibirsk | 630055 | Russia |
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| 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 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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