Study of Factors Influencing Post-stroke Dementia (strokdem)

This study is currently recruiting participants.
Verified July 2010 by University Hospital, Lille
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01330160
First received: October 1, 2010
Last updated: January 3, 2012
Last verified: July 2010

October 1, 2010
January 3, 2012
February 2010
February 2013   (final data collection date for primary outcome measure)
dementia occurrence [ Time Frame: 60 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01330160 on ClinicalTrials.gov Archive Site
  • dementia occurrence and cognitive impairment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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.

    Impairment of some tests of cognitive battery without significant impairment in activities of daily living

  • dementia occurrence and cognitive impairment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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 atient ans his/her family.

    Impairment of some tests of cognitive battery without significant impairment in activities of daily living

  • dementia occurence and cognitive impairment [ Time Frame: 36 months ] [ Designated as safety issue: No ]

    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 atient ans his/her family.

    Impairment of some tests of cognitive battery without significant impairment in activities of daily living

  • cognitive impairment [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Impairment of some tests of cognitive battery without significant impairment in activities of daily living
Same as current
Not Provided
Not Provided
 
Study of Factors Influencing Post-stroke Dementia
Characterization of Clinical, Biological, Morphological and Pharmacological Factors Influencing Occurrence of Dementia or Cognitive Disorders After Stroke

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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...).

Non-Probability Sample

Patients without dementia displaying an hemispheric ischemic or hemorrhagic stroke hospitalized during the 72h following the beginning of stroke

  • Cerebrovascular Disorders
  • Dementia
Not Provided
cohort of stroke patients
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1100
February 2018
February 2013   (final data collection date for primary outcome measure)

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
Both
40 Years to 95 Years
No
Contact: Regis Bordet, MD PhD +33 (0)3 20 44 54 49 regis.bordet@chru-lille.fr
Contact: Didier Leys, MD PhD +33 (0)3 20 44 68 14 dleys@chru-lille.fr
France
 
NCT01330160
2009-A00141-56, 2008/API1901, 2008_42/0907
No
University Hospital, Lille
University Hospital, Lille
Ministry of Health, France
Study Chair: Regis Bordet, MD PhD Lille University Hospital
University Hospital, Lille
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP