Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-02-27 @ 6:49 AM
Study NCT ID:
NCT00506818
Status:
COMPLETED
Last Update Posted:
2009-09-21
First Post:
2007-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive and Emotional Impairment After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D015140', 'term': 'Dementia, Vascular'}], 'ancestors': [{'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': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-18', 'studyFirstSubmitDate': '2007-07-23', 'studyFirstSubmitQcDate': '2007-07-23', 'lastUpdatePostDateStruct': {'date': '2009-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of vascular risk-factor-intervention on changes in TMTA, ten-words-test and HAD', 'timeFrame': '8-12 months after stroke onset'}], 'secondaryOutcomes': [{'measure': 'Prevalence of dementia and depression after stroke', 'timeFrame': '8-12 month after stroke onset'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['emotional symptoms', 'vascular risk-factors'], 'conditions': ['Stroke', 'Cognitive Impairment', 'Vascular Dementia']}, 'referencesModule': {'references': [{'pmid': '32384876', 'type': 'DERIVED', 'citation': 'Hagberg G, Ihle-Hansen H, Fure B, Thommessen B, Ihle-Hansen H, Oksengard AR, Beyer MK, Wyller TB, Muller EG, Pendlebury ST, Selnes P. No evidence for amyloid pathology as a key mediator of neurodegeneration post-stroke - a seven-year follow-up study. BMC Neurol. 2020 May 8;20(1):174. doi: 10.1186/s12883-020-01753-w.'}, {'pmid': '28583116', 'type': 'DERIVED', 'citation': 'Ihle-Hansen H, Hagberg G, Fure B, Thommessen B, Fagerland MW, Oksengard AR, Engedal K, Selnes P. Association between total-Tau and brain atrophy one year after first-ever stroke. BMC Neurol. 2017 Jun 5;17(1):107. doi: 10.1186/s12883-017-0890-6.'}, {'pmid': '26089677', 'type': 'DERIVED', 'citation': 'Ihle-Hansen H, Thommessen B, Fagerland MW, Oksengard AR, Wyller TB, Engedal K, Fure B. Blood pressure control to prevent decline in cognition after stroke. Vasc Health Risk Manag. 2015 Jun 9;11:311-6. doi: 10.2147/VHRM.S82839. eCollection 2015.'}, {'pmid': '23957255', 'type': 'DERIVED', 'citation': 'Ihle-Hansen H, Thommessen B, Fagerland MW, Oksengard AR, Wyller TB, Engedal K, Fure B. Effect on anxiety and depression of a multifactorial risk factor intervention program after stroke and TIA: a randomized controlled trial. Aging Ment Health. 2014 Jul;18(5):540-6. doi: 10.1080/13607863.2013.824406. Epub 2013 Aug 20.'}]}, 'descriptionModule': {'briefSummary': 'Cognitive and emotional symptoms are often seen in the acute phase of a stroke. The prevalence of such symptoms later and the mechanisms explaining the symptoms are not fully known. The causes of poststroke dementia are likely to be multifactorial (Cerebrovascular Diseases 2006). The investigators want to include all patients with first ever stroke without significant cognitive decline prior to the stroke (IQCODE cut-off 3,7) and follow them up for one year. At baseline we will make stroke classifications, measure neurological deficits according to NIHSS, evaluate cognitive and emotional function and make registrations of vascular risk factors, including precerebral color duplex scan with measurement of IMT in CCA. The investigators will then randomize the patients into multifactorial vascular-risk-factor-intervention in the hospital or care as usual in the primary health care. 8-12 months after stroke onset, survivors will undergo new examinations to evaluate neurological, cognitive and emotional functions, as well as MRI and SPECT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First ever stroke or TIA\n* No cognitive decline (IQCODE \\< 3,7)\n* Survived the acute stroke\n* Expected to live at least for one year after stroke\n\nExclusion Criteria:\n\n* Cognitive decline'}, 'identificationModule': {'nctId': 'NCT00506818', 'briefTitle': 'Cognitive and Emotional Impairment After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Sykehuset Asker og Baerum'}, 'officialTitle': 'Cognitive and Emotional Impairment After Stroke', 'orgStudyIdInfo': {'id': '1.2006.2076(REK)'}, 'secondaryIdInfos': [{'id': '1.2006.2076(REK)'}, {'id': '16307(NSD)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Intensive risk factor intervention', 'interventionNames': ['Other: Multifactorial vascular-risk-factor-intervention']}], 'interventions': [{'name': 'Multifactorial vascular-risk-factor-intervention', 'type': 'OTHER', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'RUD', 'city': 'Pb 83', 'state': '1309', 'country': 'Norway', 'facility': 'Sykehuset Asker og Baerum HF'}], 'overallOfficials': [{'name': 'Hege Ihle-Hansen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sykehuset Asker og Baerum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sykehuset Asker og Baerum', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oslo', 'class': 'OTHER'}]}}}