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21 May 2012
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| [ Print-friendly version ] |
| 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 |
| ISRCTN | ISRCTN46528154 |
| ClinicalTrials.gov identifier | NCT00449488 |
| Public title | 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 |
| Scientific title | |
| Acronym | HEBE III |
| Serial number at source | N/A |
| Study hypothesis | A single bolus erythropoietin (EPO) administered just before a primary percutaneous coronary intervention (PCI) for a first acute myocardial infarction will increase left ventricular function after four months. |
| Lay summary | |
| Ethics approval | Ethics approval details not yet received as of 26/05/06 |
| Study design | Prospective, randomised, double-blind, placebo-controlled trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Myocard infarction |
| Participants - inclusion criteria |
Successful primary PCI (thrombin inhibition in myocardial infarction [TIMI] 2/3) for a first acute myocardial infarction, diagnosed by:
1. Chest pain suggestive of acute myocardial infarction 2. Symptom onset <12 hours after hospital admission, or <24 hours in case ongoing ischemia 3. Electrocardiogram (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 spinothalamic tract |
| Participants - exclusion criteria |
1. Hemoglobin levels >10.6 mmol/l
2. Anticipated additional revascularisation within four months 3. Cardiogenic shock 4. Presence of other serious medical conditions 5. Pregnant/breast feeding 6. Malignant hypertension 7. End stage renal failure (creatinine >220 micromol/l) 8. Previous treatment with recombinant human erythropoietin (rh-EPO) 9. Blood transfusion <12 weeks prior to randomisation 10. Allergy against rh-EPO 11. Polycythemia vera 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 magnetic resonance imaging (MRI) (pacemaker and other metal subjects) |
| Anticipated start date | 01/09/2006 |
| Anticipated end date | 01/09/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 400 |
| Interventions | One bolus of EPO (Eprex, about 60.000 IU) will be administered intravenously in 30 minutes, within 3 hours after the primary PCI procedure versus placebo |
| Primary outcome measure(s) | The main study endpoint will be left ventricular ejection faction, measured with cardiac magnetic resonance imaging at four months after onset of the acute myocardial infarction |
| Secondary outcome measure(s) |
Secondary study endpoints are:
1. Myocardial infarct size, summarised as the percentage of left ventricular mass, measured with cardiac magnetic resonance imaging at four months after onset of the acute myocardial infarction 2. Cardiovascular events (cardiovascular death, re-myocardial infarction, re-PCI or coronary artery bypass graft (CABG), stroke, heart failure) from the onset of the acute myocardial infarction to four months afterwards 3. Enzymatic infarct size with computerised measurements of creatine kinase (CK) and creatine kinase myocardial band (CK-MB) 4. Safety endpoint: incidence of death, stroke, onset or worsening of congestive heart failure (CHF), deep vein thrombosis, malignant hypertension (risk ratio [RR] >250/125), re-myocardial infarction, pulmonary embolism, seizure |
| Sources of funding | University Medical Center Groningen (UMCG) and Interuniversity Institute of Cardiology (ICIN), The Netherlands |
| Trial website | |
| Publications | |
| Contact name | Dr J. Hogenhuis |
| Address |
University Medical Center Groningen (UMCG)
Trial Coordiantion Center P.O. Box 30001 |
| City/town | Groningen |
| Zip/Postcode | 9700 RB |
| Country | Netherlands |
| Tel | +31 (0)50 3618061 |
| Fax | +31 (0)50 3618062 |
| j.hogenhuis@thorax.umcg.nl | |
| Sponsor | University Medical Center Groningen (UMCG) (The Netherlands) |
| Address |
Trial Coordination Center
P.O. Box 30001 |
| City/town | Groningen |
| Zip/Postcode | 9700 RB |
| Country | Netherlands |
| Date applied | 26/05/2006 |
| Last edited | 24/08/2007 |
| Date ISRCTN assigned | 26/05/2006 |
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| © 2012 ISRCTN unless otherwise stated. | |
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