Ignite Creation Date:
2024-05-05 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00524901
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2007-09-04
Brief Title:
Study of the Use of a Single Dose of Erythropoietin to Treat Acute Myocardial Ischemia
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
An Open Label Study to Evaluate the Effect of Intravenous Erythropoietin on Erythropoietin Receptor Signaling and Markers for Apoptosis Myocardial Damage and Renal Dysfunction in Patients Undergoing Coronary Artery Bypass Graft CABG Surgery
Status:
COMPLETED
Status Verified Date:
2013-02
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:
DREAM
Brief Summary:
This is a phase 2 study that evaluates the effect of intravenous administration of a bolus EPO on the activation of EPOR-signal transduction cascades and myocardial apoptosis during cardiopulmonary bypass surgery Human atrial and ventricular tissue will be collected during CABG surgery for 3-vessel disease for the assay of EPOR signaling and apoptosis Two atrial specimens will be collected before and at the end of cardiopulmonary bypass CPB Concomitantly two transmural ventricular biopsies will be obtained at the start and at the end of CPB Immediately after obtaining the first atrial biopsy one bolus of EPO will be administered intravenously The atrial tissue will be split and appropriate sections will be frozen for determination of baseline expression or activity of a number of molecules including Erk12 STAT5 Akt and caspase-3 or embedded in paraffin for immunohistochemistry Ventricular tissue will only be processed for immunohistochemistry Additionally plasma will be collected before the procedure and for up to 30 days post-procedure to examine release of markers of both myocardial ischemia and stress CK-MB Troponin T and NT-proBNP and renal dysfunction cystatin C creatinine for eGFR Before initializing the randomised study a pilot study will be performed with 5 subjects that will not be treated to evaluate the feasibility of myocardial sample collection Initiation of the randomised study will only commence if baseline activity of EPOR-STC can be determined in the atrial tissue and caspase-3 positive cells can be identified in the second ventricular biopsy
Detailed Description:
None
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