HEBE III: A prospective, randomised, double blind, placebo controlled clinical study to examine the effects of a single bolus erythropoietin on left ventricular function in patients with an acute myocardial infarction.
- Conditions
- One group will receive the study medication and the other group will receive placebo medication.
- Registration Number
- NL-OMON26840
- Lead Sponsor
- Inter Cardiological Institute NetherlandsVan Buchem Stichting (UMCG)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 400
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 < 12 hour after hospital admission, or < 24 hour in case ongoing ischemia;
3. ECG with ST-T segment elevation > 1 mV in 2 or more leads;
4. TIMI flow 0/1 before primary PCI on diagnostic coronary angiography.
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method