Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2025-12-27 @ 10:32 AM
Study NCT ID:
NCT04679259
Status:
UNKNOWN
Last Update Posted:
2020-12-22
First Post:
2020-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Blood Biomarkers as an Indicator of Postoperative Cognitive Dysfunction
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 149}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-12-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2023-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-21', 'studyFirstSubmitDate': '2020-12-11', 'studyFirstSubmitQcDate': '2020-12-21', 'lastUpdatePostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of concentration of D-Amino Acid Oxidase in blood at 1, 2, and 7 day after surgery', 'timeFrame': 'At 1, 2, and 7 day after surgery', 'description': 'Blood level of D-Amino Acid Oxidase is assessed.'}], 'secondaryOutcomes': [{'measure': 'Concentration of D-serine in blood', 'timeFrame': 'At 1, 2, and 7 day after surgery', 'description': 'Blood level of D-serine is assessed.'}, {'measure': 'Concentration of Serine in blood', 'timeFrame': 'At 1, 2, and 7 day after surgery', 'description': 'Blood level of Serine is assessed.'}, {'measure': 'The incidence of postoperative cognitive dysfunction', 'timeFrame': 'At 7 day after surgery', 'description': 'The occurrence of postoperative cognitive dysfunction is evaluated at 7 day after surgery'}, {'measure': 'The incidence of postoperative delirium', 'timeFrame': 'Daily for 7 days after surgery', 'description': 'The incidence of postoperative delirium is evaluated.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Cognitive Dysfunction']}, 'descriptionModule': {'briefSummary': 'Postoperative cognitive dysfunction is defined as a cognitive decline arising after surgery. In the present study, the authors evaluate the level of D-Amino Acid Oxidase, D-serine and Serine in blood as an indicator of postoperative cognitive dysfunction after cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for elective cardiac surgery\n\nExclusion Criteria:\n\n* MMSE \\<24\n* History of psychological or neurological diseases\n* Illiteracy'}, 'identificationModule': {'nctId': 'NCT04679259', 'briefTitle': 'Evaluation of Blood Biomarkers as an Indicator of Postoperative Cognitive Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'SMG-SNU Boramae Medical Center'}, 'officialTitle': 'Evaluation of Blood Biomarkers as an Indicator of Postoperative Cognitive Dysfunction After Cardiac Surgery', 'orgStudyIdInfo': {'id': '30-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cardiac surgical patients', 'interventionNames': ['Diagnostic Test: Blood sampling for assessment of the level of D-Amino Acid Oxidase, D-serine and Serine in blood', 'Diagnostic Test: Neurocognitive test', 'Diagnostic Test: Assessment of delirium']}], 'interventions': [{'name': 'Blood sampling for assessment of the level of D-Amino Acid Oxidase, D-serine and Serine in blood', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood sampling is done before surgery and at 1, 2, and 7 day after surgery. The level of D-Amino Acid Oxidase, D-serine and Serine in blood are assessed.', 'armGroupLabels': ['Cardiac surgical patients']}, {'name': 'Neurocognitive test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Neurocognitive test is performed before surgery and at 7 day after surgery', 'armGroupLabels': ['Cardiac surgical patients']}, {'name': 'Assessment of delirium', 'type': 'DIAGNOSTIC_TEST', 'description': 'Postoperative delirium is assessed daily during 7 days after surgery.', 'armGroupLabels': ['Cardiac surgical patients']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jin-Young Hwang', 'investigatorAffiliation': 'SMG-SNU Boramae Medical Center'}}}}