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Sponsored by: |
University Medical Centre Groningen |
Information provided by: | University Medical Centre Groningen |
ClinicalTrials.gov Identifier: | NCT00524901 |
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.
Condition | Intervention | Phase |
CABG Coronary Artery Disease |
Drug: Epoetin alpha Drug: NaCl 0.9% |
Phase II |
MedlinePlus related topics: | Coronary Artery Disease |
ChemIDplus related topics: | Epoetin alfa Erythropoietin Sodium chloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
10 patients undergoing CABG for three vessel disease, receiving a single dose of erythropoietin periprocedural.
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Drug: Epoetin alpha
A single dose of epoetin alpha during CABG for three vessel disease, 60.000 IU intravenously.
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2: Placebo Comparator
10 patients undergoing CABG for three vessel disease, receiving placebo (NaCl 0.9%) periprocedural.
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Drug: NaCl 0.9%
A single dose of NaCl 0.9% during CABG for three vessel disease, 1 ml intravenously.
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Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: W. T. Ruifrok, MD | +31 50 361 61 61 ext 77758 | w.t.ruifok@thorax.umcg.nl |
Contact: B. D. Westenbrink, MD | +31 50 361 61 61 ext 77430 | b.d.westenbrink@thorax.umcg.nl |
Netherlands | |||||
University Medical Center Groningen, Dept. of Cardiology | Recruiting | ||||
Groningen, Netherlands, 9700 BD | |||||
Contact: W. T. Ruifrok, MD +31 50 361 61 61 ext 77758 w.t.ruifrok@thorax.umcg.nl | |||||
Contact: B. D. Westenbrink, MD +31 50 361 61 61 ext 77430 b.d.westenbrink@thorax.umcg.nl | |||||
Principal Investigator: W. T. Ruifok, MD |
University Medical Centre Groningen |
Study Chair: | W. H. van Gilst, Prof, dr | University Medical Center Groningen, Dept. of Exprimental Cardiology |
Principal Investigator: | W. T. Ruifrok, MD | University Medical Center Groningen, Dept. of Experimental Cardiology |
Principal Investigator: | B. D. Westenbrink, MD | University Medical Center Groningen, Dept. of Experimental Cardiology |
Principal Investigator: | A. H. Epema, dr, MD | University Medical Center Groningen, Dept. of Anaesthesiology |
Principal Investigator: | H. E. Mungroop, dr, MD | University Medical Center Groningen, Dept. of Anaesthesiology |
Principal Investigator: | P. W. Boonstra, Prof, dr, MD | University Medical Center Groningen, Dept. of Cardiothoracic Surgery |
Principal Investigator: | R. A. de Boer, dr, MD | University Medical Center Groningen, Dept of Cardiology |
Study Director: | D. J. van Veldhuisen, Prof, dr, MD | University Medical Center Groningen, Dept. of Cardiology |
Central website of the hospital 
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Responsible Party: | University Medical Centre Groningen ( W.T. Ruifrok, MD ) |
Study ID Numbers: | 2005/254 |
First Received: | September 4, 2007 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00524901 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Netherlands: Medical Ethics Review Committee (METC) |
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