Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 10:55 PM
Study NCT ID:
NCT01330160
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2010-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Factors Influencing Post-stroke Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D015140', 'term': 'Dementia, Vascular'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'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': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'standard biological parameters (ionogram, blood count, glycemia, lipids, renal function, vitamin B12, thyroid hormones, homocysteinemia), specialized biology (inflammation, oxidative, vascular biomarkers ; amyloid and tau markers), genotype (apolipoprotein E, apolipoprotein C, kinesin, Angiotensin Converting Enzyme...).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 229}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2010-10-01', 'studyFirstSubmitQcDate': '2011-04-04', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dementia occurrence', 'timeFrame': '60 months', 'description': 'This evaluation will be based on a neurological and general clinical examination, and on the evaluation of activities of daily life using the Instrumental Activities Daily Life scale after an interview with the patient and his/her family.'}], 'secondaryOutcomes': [{'measure': 'dementia occurrence and cognitive impairment', 'timeFrame': '6 months', 'description': 'This evaluation will be based on a neurological and general clinical examination, and on the evaluation of activities of daily life using the Instrumental Activities Daily Life scale after an interview with the patient and his/her family.\n\nImpairment of some tests of cognitive battery without significant impairment in activities of daily living'}, {'measure': 'dementia occurrence and cognitive impairment', 'timeFrame': '12 months', 'description': 'This evaluation will be based on a neurological and general clinical examination, and on the evaluation of activities of daily life using the Instrumental Activities Daily Life scale after an interview with the patient ans his/her family.\n\nImpairment of some tests of cognitive battery without significant impairment in activities of daily living'}, {'measure': 'dementia occurence and cognitive impairment', 'timeFrame': '36 months', 'description': 'This evaluation will be based on a neurological and general clinical examination, and on the evaluation of activities of daily life using the Instrumental Activities Daily Life scale after an interview with the patient ans his/her family.\n\nImpairment of some tests of cognitive battery without significant impairment in activities of daily living'}, {'measure': 'cognitive impairment', 'timeFrame': '36 months', 'description': 'Impairment of some tests of cognitive battery without significant impairment in activities of daily living'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stroke', 'Brain ischemia', 'Intracranial hemorrhage', 'Dementia, Vascular', "Alzheimer's disease"], 'conditions': ['Cerebrovascular Disorders', 'Dementia']}, 'referencesModule': {'references': [{'pmid': '29301969', 'type': 'RESULT', 'citation': 'Deplanque D, Bastide M, Bordet R. Transient Ischemic Attack and Minor Stroke: Definitively Not So Harmless for the Brain and Cognitive Functions. Stroke. 2018 Feb;49(2):277-278. doi: 10.1161/STROKEAHA.117.020013. Epub 2018 Jan 4. No abstract available.'}, {'pmid': '40107034', 'type': 'DERIVED', 'citation': 'Mazella E, Mendyk AM, Accart B, Borsotto M, Heurteaux C, Bordet R, Mazella J, Dondaine T. Serum sortilin-derived propeptide concentrations as markers of depression in chronic stroke. J Neurol Sci. 2025 May 15;472:123459. doi: 10.1016/j.jns.2025.123459. Epub 2025 Mar 8.'}, {'pmid': '27413577', 'type': 'DERIVED', 'citation': 'Ponchel A, Labreuche J, Bombois S, Delmaire C, Bordet R, Henon H. Influence of Medication on Fatigue Six Months after Stroke. Stroke Res Treat. 2016;2016:2410921. doi: 10.1155/2016/2410921. Epub 2016 Jun 19.'}]}, 'descriptionModule': {'briefSummary': 'If the risk of dementia occurrence after stroke is well known, few data exist about the factors influencing positively or negatively the developement of cognitive disorders or dementia. The aim of the study is so to determine prospectively the clinical, biological, lesional and pharmacological factors associated with post-stroke dementia by the long-term follow-up of a stroke patient cohort.', 'detailedDescription': 'The STROKDEM study is based on the 5-year prospective follow-up of a population of 1100 stroke patients without dementia. At inclusion in the cohort, main antecedents and risk factors, previous treatment and lifestyle, initial severity and etiology are recorded. Biological samples (for standard ans specialized analyses) and MRI are performed at 72h after stroke occurrence. Thereafter, patients are regularly (6 months, 12 months, 36 months, 60 months) examined for clinical and cognitive assessment with biological samples and Magnetic Resonance Imaging. Patients with dementia will be compared to patients without stroke to identify, by logistic regression analysis and Cox model, the factors associated with dementia occurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients without dementia displaying an hemispheric ischemic or hemorrhagic stroke hospitalized during the 72h following the beginning of stroke', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients \\> 40 years olds\n* hemispheric stroke\n* stroke dating from less 72h\n* IQ-code \\< 64\n* patient (or his family) given an informed consent\n\nExclusion Criteria:\n\n* non hemispheric stroke\n* malformative intracranial hemorrhage\n* traumatic intracranial hemorrhage\n* subarachnoidal hemorrhage\n* contra-indication to MRI\n* patients unable to answer to cognitive battery'}, 'identificationModule': {'nctId': 'NCT01330160', 'acronym': 'strokdem', 'briefTitle': 'Study of Factors Influencing Post-stroke Dementia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Characterization of Clinical, Biological, Morphological and Pharmacological Factors Influencing Occurrence of Dementia or Cognitive Disorders After Stroke', 'orgStudyIdInfo': {'id': '2008_42/0907'}, 'secondaryIdInfos': [{'id': '2008/API1901', 'type': 'OTHER_GRANT', 'domain': 'PHRC'}, {'id': '2009-A00141-56', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'cohort of stroke patients', 'description': 'patients, over 40 years old and without dementia, displaying an hemorrhagic or an ischemic stroke, with a sus-tentorial localization, and included 72h before the onset of symptoms'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80000', 'city': 'Amiens', 'country': 'France', 'facility': 'Amiens University Hospital', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '59045', 'city': 'Lille', 'country': 'France', 'facility': 'Lille University Hospital', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'Rouen University Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Regis Bordet, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Lille University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}