Study of the Use of a Single Dose of Erythropoietin to Treat Acute Myocardial Ischemia
Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
Participant gender:
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 Erk1/2, 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.