Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:42 PM
Study NCT ID:
NCT01038193
Status:
COMPLETED
Last Update Posted:
2024-02-21
First Post:
2009-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Dysfunction After Aneurysmal Subarachnoid Haemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073216', 'term': 'Mental Status and Dementia Tests'}], 'ancestors': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-19', 'studyFirstSubmitDate': '2009-12-22', 'studyFirstSubmitQcDate': '2009-12-22', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive dysfunction', 'timeFrame': '3 and 12 months', 'description': 'Montreal Cognitive Assessment'}], 'secondaryOutcomes': [{'measure': 'Neurological Outcome', 'timeFrame': '3 and 12 months', 'description': 'Modified Rankin Scale'}, {'measure': 'Generic Quality of Life', 'timeFrame': '3 and 12 months', 'description': 'ShortForm36(SF-36)'}, {'measure': 'Activity of Daily Living', 'timeFrame': '3 and 12 months', 'description': 'Barthel Index'}, {'measure': 'Disease-specific Quality of Life', 'timeFrame': '3 and 12 months', 'description': 'Stroke-specific-QOL'}, {'measure': 'Functional Outcome', 'timeFrame': '3 and 12 months', 'description': 'Functional Independent Measure (FIM)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cognition, subarachnoid hemorrhage.'], 'conditions': ['Cognitive Dysfunction']}, 'referencesModule': {'references': [{'pmid': '27165892', 'type': 'DERIVED', 'citation': 'Wong GK, Lam SW, Wong A, Ngai K, Mok V, Poon WS. Early Cognitive Domain Deficits in Patients with Aneurysmal Subarachnoid Hemorrhage Correlate with Functional Status. Acta Neurochir Suppl. 2016;122:129-32. doi: 10.1007/978-3-319-22533-3_26.'}, {'pmid': '26285662', 'type': 'DERIVED', 'citation': 'Wong GK, Wong A, Zee BC, Poon WS, Chan MT, Gin T, Siu DY, Mok VC. Cognitive outcome in acute simvastatin treatment for aneurysmal subarachnoid hemorrhage: A propensity matched analysis. J Neurol Sci. 2015 Nov 15;358(1-2):58-61. doi: 10.1016/j.jns.2015.08.013. Epub 2015 Aug 12.'}, {'pmid': '25366641', 'type': 'DERIVED', 'citation': 'Chu AC, Wong GK, Lam SW, Wong A, Ngai K, Poon WS, Mok V. Cognitive impairment in aneurysmal subarachnoid hemorrhage patients with delayed cerebral infarction: prevalence and pattern. Acta Neurochir Suppl. 2015;120:303-6. doi: 10.1007/978-3-319-04981-6_51.'}, {'pmid': '24471651', 'type': 'DERIVED', 'citation': 'Wong GK, Lam SW, Wong A, Lai M, Siu D, Poon WS, Mok V. MoCA-assessed cognitive function and excellent outcome after aneurysmal subarachnoid hemorrhage at 1 year. Eur J Neurol. 2014 May;21(5):725-30. doi: 10.1111/ene.12363. Epub 2014 Jan 28.'}, {'pmid': '24323708', 'type': 'DERIVED', 'citation': 'Wong GK, Lam SW, Wong A, Mok V, Siu D, Ngai K, Poon WS. Early MoCA-assessed cognitive impairment after aneurysmal subarachnoid hemorrhage and relationship to 1-year functional outcome. Transl Stroke Res. 2014 Apr;5(2):286-91. doi: 10.1007/s12975-013-0284-z. Epub 2013 Sep 7.'}, {'pmid': '24120271', 'type': 'DERIVED', 'citation': 'Wong GK, Lam SW, Ngai K, Wong A, Poon WS, Mok V. Development of a short form of Stroke-Specific Quality of Life Scale for patients after aneurysmal subarachnoid hemorrhage. J Neurol Sci. 2013 Dec 15;335(1-2):204-9. doi: 10.1016/j.jns.2013.09.033. Epub 2013 Oct 2.'}, {'pmid': '23606736', 'type': 'DERIVED', 'citation': 'Wong GK, Lam SW, Ngai K, Wong A, Siu D, Poon WS, Mok V; Cognitive Dysfunction after Aneurysmal Subarachnoid Hemorrhage Investigators. Cognitive domain deficits in patients with aneurysmal subarachnoid haemorrhage at 1 year. J Neurol Neurosurg Psychiatry. 2013 Sep;84(9):1054-8. doi: 10.1136/jnnp-2012-304517. Epub 2013 Apr 20.'}, {'pmid': '23573223', 'type': 'DERIVED', 'citation': 'Wong GK, Lam SW, Wong A, Ngai K, Poon WS, Mok V. Comparison of montreal cognitive assessment and mini-mental state examination in evaluating cognitive domain deficit following aneurysmal subarachnoid haemorrhage. PLoS One. 2013;8(4):e59946. doi: 10.1371/journal.pone.0059946. Epub 2013 Apr 3.'}, {'pmid': '22851612', 'type': 'DERIVED', 'citation': 'Wong GK, Lam S, Ngai K, Wong A, Mok V, Poon WS; Cognitive Dysfunction after Aneurysmal Subarachnoid Haemorrhage Investigators. Evaluation of cognitive impairment by the Montreal cognitive assessment in patients with aneurysmal subarachnoid haemorrhage: prevalence, risk factors and correlations with 3 month outcomes. J Neurol Neurosurg Psychiatry. 2012 Nov;83(11):1112-7. doi: 10.1136/jnnp-2012-302217. Epub 2012 Jul 31.'}]}, 'descriptionModule': {'briefSummary': 'This is a longitudinal, multi-center, prospective study of aneurysmal subarachnoid haemorrhage patients in neurosurgical units in Hong Kong.', 'detailedDescription': 'The investigators aim to recruit a total of 240 aneurysmal subarachnoid haemorrhage patients. The schedule for neuropsychological and functional assessments will be phased in at the second to third week, the third month, and the twelve months after the initial haemorrhage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Aneurysmal subarachnoid hemorrhage patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Spontaneous subarachnoid haemorrhage with intracranial aneurysms as aetiology\n2. Admission within 96 hours of ictus\n3. Aged between 21 and 75 years\n4. A speaker of Chinese (Mandarin or Cantonese)\n5. Informed consent from patients or their legally acceptable representatives\n\nExclusion criteria\n\n1. History of previous cerebrovascular disease or neurological disease other than intracranial aneurysm\n2. History of neurosurgical operation prior to ictus'}, 'identificationModule': {'nctId': 'NCT01038193', 'briefTitle': 'Cognitive Dysfunction After Aneurysmal Subarachnoid Haemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Cognitive Dysfunction After Aneurysmal Subarachnoid Haemorrhage', 'orgStudyIdInfo': {'id': 'GW004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'aSAH patients', 'description': 'Cognitive assessment', 'interventionNames': ['Other: Cognitive assessment']}], 'interventions': [{'name': 'Cognitive assessment', 'type': 'OTHER', 'otherNames': ['Cognition'], 'description': 'Cognitive and functional assessments at 2-4 weeks, 3 months and 12 months.', 'armGroupLabels': ['aSAH patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '852', 'city': 'Hong Kong', 'state': 'Hong Kong', 'country': 'China', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'George KC Wong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Neurosurgery, CUHK'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor (Clinical)', 'investigatorFullName': 'George KC Wong', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}