Study of Factors Influencing Post-stroke Dementia

• Conditions: Cerebrovascular Disorders; Dementia

• Registration Number: NCT01330160
• Lead Sponsor: University Hospital, Lille

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-02-27
• Study First Submitted: 2010-10-01
• Study First Submitted QC: 2011-04-04
• Study First Posted: 2011-04-06
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-25
• Last Update Posted: 2021-03-26
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

• patients > 40 years olds
• hemispheric stroke
• stroke dating from less 72h
• IQ-code < 64
• patient (or his family) given an informed consent

Exclusion Criteria

• non hemispheric stroke
• malformative intracranial hemorrhage
• traumatic intracranial hemorrhage
• subarachnoidal hemorrhage
• contra-indication to MRI
• patients unable to answer to cognitive battery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
dementia occurrence	60 months	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.

Secondary Outcome Measures

Name	Time	Method
cognitive impairment	36 months	Impairment of some tests of cognitive battery without significant impairment in activities of daily living
dementia occurrence and cognitive impairment	12 months	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.; Impairment of some tests of cognitive battery without significant impairment in activities of daily living
dementia occurence and cognitive impairment	36 months	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.; Impairment of some tests of cognitive battery without significant impairment in activities of daily living

Trial Locations

Locations (4)

Rouen University Hospital; 🇫🇷 Rouen, France

Amiens University Hospital; 🇫🇷 Amiens, France

Caen University Hospital; 🇫🇷 Caen, France

Lille University Hospital; 🇫🇷 Lille, France