Clinical trial NCT01330160: Study of Factors Influencing Post-stroke Dementia
Official title: Characterization of Clinical, Biological, Morphological and Pharmacological Factors Influencing Occurrence of Dementia or Cognitive Disorders After Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebrovascular Disorders
Dementia
Keywords: stroke
Brain ischemia
Intracranial hemorrhage
Dementia, Vascular
Alzheimer's disease
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2011-04-06
Enrollment: 1100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients without dementia displaying an hemispheric ischemic or hemorrhagic stroke hospitalized during the 72h following the beginning of stroke

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.

Eligibility criteria: 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

Primary outcomes:
measure: dementia occurrence
timeFrame: 60 months
Secondary outcomes:
measure: dementia occurrence and cognitive impairment
timeFrame: 6 months
measure: dementia occurrence and cognitive impairment
timeFrame: 12 months
measure: dementia occurence and cognitive impairment
timeFrame: 36 months
measure: cognitive impairment
timeFrame: 36 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens University Hospital
city: Caen
country: France
facility: Caen University Hospital
city: Lille
country: France
facility: Lille University Hospital
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: Lille University Hospital
name: Regis Bordet, MD PhD
role: STUDY_CHAIR
References:
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.