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| Name | Class |
|---|---|
| Fédération Française de Cardiologie | OTHER |
| Société Française de Cardiologie | OTHER |
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EPOMI is a randomized, open-label, parallel phase II clinical study that will evaluate the effects of a single erythropoietin administration on infarct size and cardiac remodeling in patients with acute myocardial infarction. Eligible patients will be randomly assigned to receive conventional therapy and single infusion of 1000U/kg of epoetin beta or conventional therapy alone. Infarct size and cardiac remodeling parameters will be assessed by cardiac magnetic resonance imaging (MRI) within 3-7 days of the randomization and repeated 3 months later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPO | Drug | Single Injection of 1000 U/kg Erythropoietin beta IV immediately after primary PCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in infarct size as assessed by magnetic resonance imaging 3 months after administration of study medication | within 3-7 days of administration of study medication |
| Measure | Description | Time Frame |
|---|---|---|
| End-systolic volume, end-diastolic volume, ejection fraction | within 3-7 days of administration of study medication, and 3 months later | |
| Changes in hemoglobin, platelets, reticulocytes blood count | during the first 10 days following study medication administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabrice PRUNIER, MD, PhD | University Hospital, Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | 49933 | France | |||
| Fabrice PRUNIER, MD, PhD, |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22305837 | Derived | Prunier F, Biere L, Gilard M, Boschat J, Mouquet F, Bauchart JJ, Charbonnier B, Genee O, Guerin P, Warin-Fresse K, Durand E, Lafont A, Christiaens L, Abi-Khalil W, Delepine S, Benard T, Furber A. Single high-dose erythropoietin administration immediately after reperfusion in patients with ST-segment elevation myocardial infarction: results of the erythropoietin in myocardial infarction trial. Am Heart J. 2012 Feb;163(2):200-7.e1. doi: 10.1016/j.ahj.2011.11.005. |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Occurrence of major cardiac event or venous thrombotic events | within 12 months following administration of study medication |
| Angers |
| 49933 |
| France |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |