Patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention. MedDRA version: 8.1 Level: LLT Classification code 10000891 Term: Acute myocardial infarction
Conditions
Interventions
Trade Name: NeoRecormon® Multidose 50 000 IE
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: epoetin beta (recombinant human erythropoietin)
CAS Number: 80000
Sponsors
Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with ST-segment elevation myocardial infarction =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Age = 18 years and > 80 years. 2. Cardiogenic shock. 3. Pericarditis. 4. Malignancies/other comorbid conditions conditions with life expectancy 160/100mmHg unresponsive to therapy 8. Epilepsy. 9. Active bleeding; bleeding diathesis; history of gastrointestinal or genitourinary bleeding, recent trauma or major surgery 160 g/l platelet count 600 x 10^9 cells/l. 12. Any contraindication to magnetic resonance imaging: electronically, magnetically, and mechanically activated implants such as cardiac pacemakers, automatic cardioverter defibrillators, joint prostheses, surgical/vascular clips, hearing aids, neurostimulators, infusion pumps, etc metallic splinters in the eye ferromagnetic haemostatic clips in the central nervous system cochlear implants lead wires or similar wires prosthetic heart valves, if dehiscence is suspected non-ferromagnetic stapedial implants; haemostatic clips 13. Glomerular filtration rate 30 mg/l or dependence on renal dialysis. 14. Chronic liver disease with GOT > 5-fold over the normal range. 15. Allergy to erythropoietin / true anaphylaxis after prior exposure to contrast media 16. Phenylketonuria 17. Previous enrollment in this trial. 18. Women who are known to be pregnant, who are of childbearing potential and test positive for pregnancy, who have given birth within the last 90 days, who are breastfeeding. 19. Patient’s inability to fully cooperate with the study protocol. 20. Other contraindication according to the summary of product characteristics of recombinant human erythropoietin beta (NeoRecormon®).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the effects of intravenous erythropoietin after reperfusion on the left ventricular ejection fraction at 4-6 months follow-up measured by magnetic resonance imaging (MRI) in patients with STEMI undergoing primary PCI.;Secondary Objective: Changes in left ventricular ejection fraction and infarct size from 5-7 days and 4-6 months after randomization measured by MRI. Changes in infarct size from 5-7 days to 4-6 months after randomization measured by SPECT Changes in angiographically determined left ventricular ejection fraction and hypokinetic chords from baseline to 4-6 months after randomization. Death, recurrent myocardial infarction, recurrent intervention in the infarct related artery in hospital, at 30 days and 6 months. ;Primary end point(s): Left ventricular ejection fraction measured by magnetic resonance imaging at 4-6 months after randomization. | — |
Countries
Germany
Outcome results
None listed