Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-26 @ 6:09 PM
Study NCT ID:
NCT01550159
Status:
UNKNOWN
Last Update Posted:
2012-03-09
First Post:
2012-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Markers of Neuronal Injury and Cognitive Dysfunction After Coronary Artery Bypass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-06', 'studyFirstSubmitDate': '2012-02-06', 'studyFirstSubmitQcDate': '2012-03-06', 'lastUpdatePostDateStruct': {'date': '2012-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score in Neuropsycological Tests', 'timeFrame': '1 year', 'description': 'Tests for evaluation of quality of life, depressive synths and neuropsycho;logical battery to assess general mental status, learning, attention, visuospatial perception, immediate memory, operational and executive ask and recall, including processing speed. This assessment will be applied before surgery, and 3, 7,21 90 and 180 days after surgery.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Postoperative Cognitive Dysfunction', 'Cardiac Surgery', 'General Anesthesia', 'Neuropsychological Tests'], 'conditions': ['Postoperative Cognitive Dysfunction']}, 'referencesModule': {'references': [{'pmid': '27433840', 'type': 'DERIVED', 'citation': 'Silva FP, Schmidt AP, Valentin LS, Pinto KO, Zeferino SP, Oses JP, Wiener CD, Otsuki DA, Tort AB, Portela LV, Souza DO, Auler JO Jr, Carmona MJ. S100B protein and neuron-specific enolase as predictors of cognitive dysfunction after coronary artery bypass graft surgery: A prospective observational study. Eur J Anaesthesiol. 2016 Sep;33(9):681-9. doi: 10.1097/EJA.0000000000000450.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the possible Correlation Between Serum Levels of Markers of Neuronal Injury and Cognitive Dysfunction after Coronary Artery Bypass Surgery.', 'detailedDescription': 'The systemic inflammatory response after cardiac surgery may cause damage to the central nervous system and elevated markers of brain injury in peripheral blood. This event may be potentially related to the development of postoperative cognitive dysfunction (POCD), with incidences varying from 20 to 83%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients underwent for coronary artery bypass graft surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients underwent for coronary artery bypass graft surgery\n\nExclusion Criteria:\n\n* History of brain disease or dementia, other psychiatric disorders that affect cognition\n* Lack of proficiency in Portuguese language'}, 'identificationModule': {'nctId': 'NCT01550159', 'briefTitle': 'Correlation Between Markers of Neuronal Injury and Cognitive Dysfunction After Coronary Artery Bypass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Study of Correlation Between Serum Levels of Markers of Neuronal Injury and Cognitive Dysfunction After Coronary Artery Bypass Graft Surgery', 'orgStudyIdInfo': {'id': '1081/04'}}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Maria JC Carmona, M.D.', 'role': 'CONTACT', 'email': 'maria.carmona@incor.usp.br', 'phone': '55-11-3069-6335'}, {'name': 'Fernando CP Silva', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'General Hospital of the University od São Paulo Medical School', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Maria JC Carmona, M.D.', 'role': 'CONTACT', 'email': 'maria.carmona@incor.usp.br', 'phone': '55-11-3069-6335'}, {'name': 'Fernando CP Silva', 'role': 'CONTACT', 'email': 'fernandoprado@usp.br', 'phone': '55-11-3069-6335'}], 'overallOfficials': [{'name': 'Maria JC Carmona, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maria José Carvalho Carmona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Study of Correlation Between Serum Levels of Markers of Neuronal Injury and Cognitive Dysfunction after Coronary Artery Bypass Surgery', 'investigatorFullName': 'Maria José Carvalho Carmona', 'investigatorAffiliation': 'University of Sao Paulo'}}}}