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Study of Factors Influencing Post-stroke Dementia (strokdem)

This study is currently recruiting participants.
Verified November 2017 by University Hospital, Lille
Sponsor:
ClinicalTrials.gov Identifier:
NCT01330160
First Posted: April 6, 2011
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille
  Purpose
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.

Condition
Cerebrovascular Disorders Dementia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Clinical, Biological, Morphological and Pharmacological Factors Influencing Occurrence of Dementia or Cognitive Disorders After Stroke

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • dementia occurrence [ Time Frame: 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:
  • dementia occurrence and cognitive impairment [ Time Frame: 6 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.

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


  • dementia occurrence and cognitive impairment [ Time Frame: 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 [ Time Frame: 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


  • cognitive impairment [ Time Frame: 36 months ]
    Impairment of some tests of cognitive battery without significant impairment in activities of daily living


Biospecimen Retention:   Samples With DNA
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...).

Estimated Enrollment: 1100
Actual Study Start Date: February 27, 2010
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330160


Contacts
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

Locations
France
Amiens University Hospital Active, not recruiting
Amiens, France, 80000
Caen University Hospital Active, not recruiting
Caen, France, 14000
Lille University Hospital Recruiting
Lille, France, 59045
Contact: Régis 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   
Principal Investigator: Régis Bordet, MD PhD         
Principal Investigator: Didier Leys, MD PhD         
Sub-Investigator: Hilde Henon, MD PhD         
Sub-Investigator: Lucas Christian, MD PhD         
Sub-Investigator: Girot Marie, MD phD         
Sub-Investigator: Cordonnier Charlotte, MD PhD         
Sub-Investigator: Frederic Dumont, MD         
Sub-Investigator: Bodenant Marie, MD         
Principal Investigator: Florence Pasquier, MD PhD         
Sub-Investigator: Stéphanie Bombois, MD PhD         
Sub-Investigator: Marie-Anne Mackowiak, MD         
Sub-Investigator: Vincent Deramecourt, MD PhD         
Sub-Investigator: Marion Paulin, MD         
Sub-Investigator: Florence Lebert, MD PhD         
Rouen University Hospital Recruiting
Rouen, France, 76000
Contact: Didier Hannequin, MD PhD       Didier.Hannequin@chu-rouen.fr   
Principal Investigator: Didier Hannequin, MD PhD         
Sub-Investigator: Evelyne Guegan-Massardier, MD         
Sub-Investigator: Aude Triquenot-Bagan, MD         
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
Study Chair: Regis Bordet, MD PhD Lille University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01330160     History of Changes
Other Study ID Numbers: 2008_42/0907
2008/API1901 ( Other Grant/Funding Number: PHRC )
2009-A00141-56 ( Other Identifier: ID-RCB number, ANSM )
First Submitted: October 1, 2010
First Posted: April 6, 2011
Last Update Posted: November 9, 2017
Last Verified: November 2017

Keywords provided by University Hospital, Lille:
stroke
Brain ischemia
Intracranial hemorrhage
Dementia, Vascular
Alzheimer's disease

Additional relevant MeSH terms:
Dementia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Vascular Diseases
Cardiovascular Diseases