Trial record 9 of 2434 for:    Dementia

Study of Factors Influencing Post-stroke Dementia (strokdem)

This study is currently recruiting participants. (see Contacts and Locations)
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
  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 ] [ 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.


Secondary Outcome Measures:
  • 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


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
Study Start Date: February 2010
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2013 (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

Ages Eligible for Study:   40 Years to 95 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01330160     History of Changes
Other Study ID Numbers: 2009-A00141-56, 2008/API1901, 2008_42/0907
Study First Received: October 1, 2010
Last Updated: January 3, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Dementia
Delirium, Dementia, Amnestic, Cognitive Disorders
Cerebrovascular Disorders
Disease
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Mental Disorders
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014