Myocardial Infarction
Conditions
Keywords
erythropoietin, myocardial infarction, PCI, left ventricular function
Brief summary
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
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.
Interventions
DRUGepoetin alfa
epoetin alfa 60.000 IU one i.v. bolus
Sponsors
The Interuniversity Cardiology Institute of the Netherlands
Janssen-Cilag Ltd.
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left ventricular ejection fraction 6 weeks after primary PCI, measured with planar radionuclide ventriculography | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety, myocardial infarct size, and cardiovascular events at 6 weeks after a single bolus of EPO | Cardiovascular Events |
Countries
Netherlands
Outcome results
None listed