Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449488
Status:
COMPLETED
Last Update Posted:
2009-12-15
First Post:
2007-03-18
Brief Title:
Clinical Study to Examine the Effects of Erythropoietin on Left Ventricular Function After Acute Myocardial Infarction
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
A Prospective Randomised Clinical Study to Examine the Effects of a Single Bolus Erythropoietin on Left Ventricular Function in Patients With an Acute Myocardial Infarction
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEBEIII
Brief Summary:
The primary objective of this study is to establish the effects of a single bolus of EPO administered within three hours after a primary PCI for a first acute myocardial infarction on left ventricular function
Detailed Description:
Erythropoetin EPO is commonly known as an effective treatment for anemia However several important extra-hematopoeitic effects of EPO are suggested which might be beneficial in the setting of an acute myocardial infarction such as a reduction of apoptosis and stimulation of neovascularisation Recent animal studies provided very consistent evidence for a reduced infarct size and improved left ventricular function caused by EPO administration However clinical studies with EPO in non-anemic patients are scarce
We performed a safety study in our department on the effects of a single bolus of EPO in patients with an acute myocardial infarction Serum EPO levels increased a 200-fold and EPO administration was not associated with hypertension nor with an increase in thrombocytes or thrombotic events
In conclusion experimental data clearly showed that a single bolus of EPO after the onset of an acute myocardial infarction reduced myocardial infarct size and improved left ventricular function In our safety study EPO administration in patients with an acute myocardial infarction was safe and well tolerated
This will be a PROBE Prospective Randomised Open label study with Blinded Endpoint designed study in wich one group will receive one bolus of EPO 60000 IU intravenously within 3 hours after the primary PCI procedure and the other group will receive standard therapy After 6 weeks left ventricular ejection fraction will be evaluated by planar radionuclide ventriculography
We performed a safety study in our department on the effects of a single bolus of EPO in patients with an acute myocardial infarction Serum EPO levels increased a 200-fold and EPO administration was not associated with hypertension nor with an increase in thrombocytes or thrombotic events
In conclusion experimental data clearly showed that a single bolus of EPO after the onset of an acute myocardial infarction reduced myocardial infarct size and improved left ventricular function In our safety study EPO administration in patients with an acute myocardial infarction was safe and well tolerated
This will be a PROBE Prospective Randomised Open label study with Blinded Endpoint designed study in wich one group will receive one bolus of EPO 60000 IU intravenously within 3 hours after the primary PCI procedure and the other group will receive standard therapy After 6 weeks left ventricular ejection fraction will be evaluated by planar radionuclide ventriculography
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN46528154 | None | None | None |