One group will receive the study medication and the other group will receive placebo medication.
Conditions
Interventions
1. One bolus of EPO (Eprex, about 60.000 IU) will be administered intravenously in 30 minutes, within 3 hours after the primary PCI procedure. OR
2. Placebo
Sponsors
Inter Cardiological Institute Netherlands
Van Buchem Stichting (UMCG)
Eligibility
Inclusion criteria
Inclusion criteria: Successful primary PCI (TIMI 2/3) for a first acute myocardial infarction, diagnosed by: 1. Chest pain suggestive for acute myocardial infarction; 2. Symptom onset 1 mV in 2 or more leads; 4. TIMI flow 0/1 before primary PCI on diagnostic coronary angiography.
Exclusion criteria
Exclusion criteria: 1. Hemoglobin levels > 10.6 mmol/L; 2. Anticipated additional revascularisation within 4 months; 3. Cardiogenic shock; 4. Presence of other serious medical conditions; 5. Pregnancy/breast feeding; 6. Malignant hypertension; 7. End stage renal failure (kreatinin > 220 micromol/l); 8. Previous treatment with rh-EPO; 9. Blood transfusion <12 weeks prior to randomisation; 10. Allergy against rh-EPO; 11. Polycytemia verae; 12. Previous acute myocardial infarction; 13. Concomitant inflammatory or malignant disease; 14. Recent trauma or major surgery; 15. Unwilling to sign informed consent; 16. Contra-indications for MRI (pacemaker and other metal subjects).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint will be left ventricular ejection faction, measured with Cardiac Magnetic Resonance Imaging at 4 months after onset of the acute myocardial infarction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints are: 1. Myocardial infarct size, summarised as the percentage of left ventricular mass, measured with Cardiac Magnetic Resonance Imaging at 4 months after onset of the acute myocardial infarction; 2. Cardiovascular events (cardiovascular death, re-myocardial infarction, re-PCI or CABG, stroke, heart failure) from the onset of the acute myocardial infarction to 4 months afterwards; 3. Enzymatic infarct size with computerised measurements of CK and CK-MB; 4. Safety endpoint: Incidence of death, stroke, onset or worsening of CHF, deep vein thrombosis, malignant hypertension (RR>250/125), re-myocardial infarction, pulmonary embolism, seizure. | — |
Contacts
Public ContactJ. Hogenhuis
University Medical Center Groningen (UMCG), Trial Coordiantion Center, P.O. Box 30001
Outcome results
None listed