Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2026-03-01 @ 2:45 AM
Study NCT ID:
NCT04250935
Status:
COMPLETED
Last Update Posted:
2020-12-03
First Post:
2020-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain-Induced Neurotrophic Factor Levels in Patients Undergoing Coronary Artery Bypass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-02', 'studyFirstSubmitDate': '2020-01-30', 'studyFirstSubmitQcDate': '2020-01-30', 'lastUpdatePostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative cognitive dysfunction', 'timeFrame': '4 days', 'description': 'Relationship between serum brain-derived neurotrophic factor level and cognitive dysfunction'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Dysfunction']}, 'referencesModule': {'references': [{'pmid': '33774438', 'type': 'DERIVED', 'citation': 'Miniksar OH, Cicekcioglu F, Kilic M, Honca M, Miniksar DY, Gocmen AY, Kacmaz O, Oz H. Decreased brain-derived neurotrophic factor levels may predict early perioperative neurocognitive disorder in patients undergoing coronary artery bypass surgery: A prospective observational pilot study. J Clin Anesth. 2021 Aug;71:110235. doi: 10.1016/j.jclinane.2021.110235. Epub 2021 Mar 25.'}]}, 'descriptionModule': {'briefSummary': 'In patients undergoing coronary artery bypass surgery, the relationship between neurocognitive changes seen in the early period and brain-induced neurotrophic factor serum levels will be investigated.', 'detailedDescription': 'Although postoperative cognitive dysfunction (POKD) is the most common neurological complication in patients undergoing coronary artery bypass grafting (CABG) surgery, its pathophysiology is still not fully understood. However, the quality of this dysfunction has not been properly measured. In addition to clinical tests, biomarkers are often used to detect the presence of POKD. In this study, it was aimed to evaluate the relationship between intraoperative and postoperative brain-derived neurotrophic factor serum levels and POKD in patients undergoing CABG surgery.\n\nThis prospective observational study is planned to include 30 adult patients aged 40-90 years. Patients with stroke history, neurodegenerative disease, seizure history, alcohol use, general anxiety, hearing deficit, unilateral carotid artery stenosis greater than 70%, and carotid artery bilateral stenosis greater than 50% will be excluded from the study.\n\nThis study aimed to determine perioperative changes in serum brain-derived neurotrophic factor levels in patients undergoing CABG surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Volunteer patients to be included in the study: 30 adult patients who will undergo coronary artery bypass grafting (CABG) surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At Least Primary School Graduates,\n* Not Using Drugs That May Affect Cognitive Functions,\n* No Alcohol Substance Use,\n* Without Psychiatric And Neurological Diseases\n\nExclusion Criteria:\n\n* Uneducated Patients,\n* Drug Users Who May Affect Cognitive Functions (Antipsychotic, Antidepressant),\n* Have Alcohol And Substance Use Disorders,\n* Those With A History Of Central Nervous System Disease That May Cause Cognitive Dysfunction (Such As Stroke, Neurodegenerative Disease, Seizure, General Anxiety),\n* Hearing Deficit,\n* Patients With Unilateral Carotid Artery Stenosis Greater Than 70% And Bilateral Stenosis Greater than 50% Carotid Artery'}, 'identificationModule': {'nctId': 'NCT04250935', 'briefTitle': 'Brain-Induced Neurotrophic Factor Levels in Patients Undergoing Coronary Artery Bypass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Bozok University'}, 'officialTitle': 'The Relationship Between Neurocognitive Changes and Brain-Induced Neurotrophic Factor Levels in Patients Undergoing Coronary Artery Bypass Surgery', 'orgStudyIdInfo': {'id': '20194466'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Patients with cognitive dysfunction', 'type': 'DIAGNOSTIC_TEST', 'description': 'Mini Mental Test Those with a score below 21 points'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yozgat', 'country': 'Turkey (Türkiye)', 'facility': 'Bozok University Medical Center', 'geoPoint': {'lat': 39.82, 'lon': 34.80444}}], 'overallOfficials': [{'name': 'Yozgat Bozok University Research Hospital', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yozgat'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Can be announced after the work is completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bozok University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asist.Prof.', 'investigatorFullName': 'Ökkeş Hakan Miniksar', 'investigatorAffiliation': 'Bozok University'}}}}