Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-26 @ 3:28 PM
Study NCT ID:
NCT00824759
Status:
WITHDRAWN
Last Update Posted:
2014-11-19
First Post:
2009-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardioprotective Effects of Increased Endogenous Erythropoietin After Normobaric Oxygen Breathing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Because it seemed not of interest based on the current literature', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'lastUpdateSubmitDate': '2014-11-18', 'studyFirstSubmitDate': '2009-01-16', 'studyFirstSubmitQcDate': '2009-01-16', 'lastUpdatePostDateStruct': {'date': '2014-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'decrease in Troponin-I values', 'timeFrame': '12h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy subjects', 'CABG', 'Patients undergoing coronary artery bypass graft under cardiopulmonary bypass'], 'conditions': ['Healthy', 'Coronary Artery Bypass Graft']}, 'referencesModule': {'references': [{'pmid': '16239610', 'type': 'BACKGROUND', 'citation': 'Balestra C, Germonpre P, Poortmans JR, Marroni A. Serum erythropoietin levels in healthy humans after a short period of normobaric and hyperbaric oxygen breathing: the "normobaric oxygen paradox". J Appl Physiol (1985). 2006 Feb;100(2):512-8. doi: 10.1152/japplphysiol.00964.2005. Epub 2005 Oct 20.'}, {'pmid': '14523037', 'type': 'BACKGROUND', 'citation': 'Parsa CJ, Matsumoto A, Kim J, Riel RU, Pascal LS, Walton GB, Thompson RB, Petrofski JA, Annex BH, Stamler JS, Koch WJ. A novel protective effect of erythropoietin in the infarcted heart. J Clin Invest. 2003 Oct;112(7):999-1007. doi: 10.1172/JCI18200.'}]}, 'descriptionModule': {'briefSummary': 'Tissue hypoxia is the only accepted trigger for erythropoietin (EPO) production. However, in healthy subjects EPO concentrations have also increased after oxygen breathing. The aim of our study is to confirm these observations.\n\nBesides its main function in erythropoiesis, EPO has also shown tissue protective effects. The second goal of our study is to observe the cardioprotective effects of increased endogenous EPO, induced after normobaric oxygen breathing.', 'detailedDescription': 'Currently, renal tissue hypoxia is the only widely accepted trigger for erythropoietin (EPO) production. However, previous studies in healthy subjects have demonstrated that a sudden and sustained decrease in tissue oxygen level, aside from an absolute low level of tissue oxygen tension, could also act as a trigger for EPO production. To confirm these observations and to clarify an eventual role of free oxygen radicals and antioxidants, hypobaric pure oxygen will be administered to healthy subjects.\n\nThe major physiologic function of EPO is thought to be the induction of erythropoiesis. However, a growing body of evidence indicates that EPO has tissue-protective effects and prevents tissue damage during ischemia. In an ex vivo proof-of-concept, protective effects of EPO have been shown in human myocardium.\n\nThe second goal of our study is to observe the cardioprotective effects of increased endogenous EPO, induced after normobaric oxygen breathing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy non-smokers; patients undergoing CABG under cardiopulmonary bypass\n\nExclusion Criteria:\n\n* Subjects with a pulmonary disease; subjects who have stayed at high altitude since at least 3 months; healthy subjects taking medication; patients undergoing a redo or combined cardiac surgery; patients with renal insufficiency; any emergency CABG; Patients with pulmonary disease'}, 'identificationModule': {'nctId': 'NCT00824759', 'briefTitle': 'Cardioprotective Effects of Increased Endogenous Erythropoietin After Normobaric Oxygen Breathing', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'orgStudyIdInfo': {'id': '2008/24NOV/331'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Other: pure oxygen breathing versus air']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'oxygen', 'interventionNames': ['Other: pure oxygen breathing versus air']}], 'interventions': [{'name': 'pure oxygen breathing versus air', 'type': 'OTHER', 'description': 'one group will breath pure oxygen; the other will breath air', 'armGroupLabels': ['oxygen', 'placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD; Chef de Clinique Adjointe, Department of Anesthesiology', 'investigatorFullName': 'Momeni', 'investigatorAffiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}}}}