Clinical Study to Examine the Effects of Erythropoietin on Left Ventricular Function After Acute Myocardial Infarction

Study Overview
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Brief Summary
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The primary objective of this study is to establish the effects of a single bolus of EPO, administered within three hours after a primary PCI for a first acute myocardial infarction, on left ventricular function.

Detailed Description
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Erythropoetin (EPO) is commonly known as an effective treatment for anemia. However, several important extra-hematopoeitic effects of EPO are suggested which might be beneficial in the setting of an acute myocardial infarction, such as a reduction of apoptosis and stimulation of neovascularisation. Recent animal studies provided very consistent evidence for a reduced infarct size and improved left ventricular function caused by EPO administration. However, clinical studies with EPO in non-anemic patients are scarce. We performed a safety study in our department on the effects of a single bolus of EPO in patients with an acute myocardial infarction. Serum EPO levels increased a 200-fold and EPO administration was not associated with hypertension, nor with an increase in thrombocytes or thrombotic events. In conclusion, experimental data clearly showed that a single bolus of EPO after the onset of an acute myocardial infarction reduced myocardial infarct size, and improved left ventricular function. In our safety study, EPO administration in patients with an acute myocardial infarction was safe and well tolerated. This will be a PROBE (Prospective, Randomised, Open label study with Blinded Endpoint) designed study, in wich one group will receive one bolus of EPO 60.000 IU) intravenously within 3 hours after the primary PCI procedure and the other group will receive standard therapy. After 6 weeks left ventricular ejection fraction will be evaluated by planar radionuclide ventriculography.

Official Title
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A Prospective, Randomised, Clinical Study to Examine the Effects of a Single Bolus Erythropoietin on Left Ventricular Function in Patients With an Acute Myocardial Infarction

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: epoetin alfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Successful primary PCI (TIMI 2/3) for a first acute myocardial infarction, diagnosed by: chest pain suggestive for acute myocardial infarction symptom onset < 12 hour before hospital admission, or < 24 hour in case ongoing ischemia ECG with ST-T segment elevation > 1 mV in 2 or more leads TIMI flow 0/1 before primary PCI on diagnostic coronary angiography; Exclusion Criteria: Hemoglobin levels > 10.6 mmol/L; Anticipated additional revascularisation within 4 months; Cardiogenic shock; Presence of other serious medical conditions Pregnancy/breast feeding Malignant hypertension End stage renal failure (creatinin > 220 micromol/l) Previous treatment with rh-EPO Blood transfusion <12 weeks prior to randomisation Polycythemia vera Previous acute myocardial infarction Concomitant inflammatory or malignant disease Recent trauma or major surgery Unwilling to sign informed consent Atrial fibrillation

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Active Comparator: Epoetin alfa<br>i.v bolus 60.000 IU epoetin alfa | Drug: epoetin alfa<br>* epoetin alfa 60.000 IU one i.v. bolus<br>* Other names: Eprex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction 6 weeks after primary PCI, measured with planar radionuclide ventriculography |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, myocardial infarct size, and cardiovascular events at 6 weeks after a single bolus of EPO |  | Cardiovascular Events | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCI, erythropoietin, myocardial infarction, left ventricular function