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 infarctio

Not Applicable

Completed

• Conditions: Myocard infarction; Circulatory System

• Registration Number: ISRCTN46528154
• Lead Sponsor: niversity Medical Center Groningen (UMCG) (The Netherlands)

Brief Summary

1. 2008 protocol in https://www.ncbi.nlm.nih.gov/pubmed/18440327 (added 07/02/2019) 2. 2010 results in https://www.ncbi.nlm.nih.gov/pubmed/20802250 (added 07/02/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-26
• Study Completion: 2008-09-01
• Last Update Posted: 4 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
<br> Secondary study endpoints are:<br> 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<br> 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<br> 3. Enzymatic infarct size with computerised measurements of creatine kinase (CK) and creatine kinase myocardial band (CK-MB)<br> 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<br>