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 - HEBE III
- Conditions
- Patients with a successful primary PCI (TIMI 2/3) for a first acute myocardial infarction
- Registration Number
- EUCTR2006-002940-28-NL
- Lead Sponsor
- ICI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 400
Successful primary PCI (TIMI 2/3) for a first acute myocardial infarction, diagnosed by:
a.chest pain suggestive for acute myocardial infarction
b.symptom onset < 12 hour before hospital admission, or < 24 hour in case ongoing ischemia
c.ECG with ST-T segment elevation > 1 mV in 2 or more leads
d.TIMI flow 0/1 before primary PCI on diagnostic coronary angiography;
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
a.Hemoglobin levels > 10.6 mmol/L;
b.Anticipated additional revascularisation within 4 months;
c.Cardiogenic shock;
d.Presence of other serious medical conditions
e.Pregnancy/breast feeding
f.Malignant hypertension
g.End stage renal failure (kreatinin > 220 ?mol/l)
h.Previous treatment with rh-EPO
i.Blood transfusion <12 weeks prior to randomisation
j.Allergy against rh-EPO
k.Polycytemia verae
l.Previous acute myocardial infarction
m.Concomitant inflammatory or malignant disease
n.Recent trauma or major surgery
o.Unwilling to sign informed consent
p.contra-indications for MRI (pacemaker and other metal subjects)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to establish the effects of a single bolus EPO administered just before a primary PCI for a first acute myocardial infarction, on left ventricular ejection fraction after 4 months, measured with Cardiac Magnetic Resonance Imaging (MRI). ;Secondary Objective: The secondary objective of this study is to establish the effects of a single bolus EPO on safety, myocardial infarct size, and cardiovascular events in patients after a first acute myocardial infarction. ;Primary end point(s): The main study endpoint will be left ventricular ejection faction, measured with <br>Cardiac Magnetic Resonance Imaging at 4 months after onset of the acute <br>myocardial infarction
- Secondary Outcome Measures
Name Time Method