Post-stroke Cognitive Impairment and Dementia (GRECogVASC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01339195
First received: February 22, 2011
Last updated: December 5, 2011
Last verified: February 2011
  Purpose

Projections from epidemiological studies suggest that, among the Western adult population, one in three will present a cerebrovascular accident (stroke), severe cognitive disorders, or both. To better diagnose the Vascular Cognitive Impairment, new standards were developed by a North America working group which are under validation. It is essential to adapt these standard for French-speaking population, and especially to define cutoff scores of the cognitive battery to determine cognitive deficit.

The investigators propose a study coordinated by the University-Hospital of Amiens for french speaking centers. This study will investigate this battery with 906 controls to define the standards and 302 stroke affected patients to define the frequency and cognitive mechanisms. This step is essential for people to benefit from these new standards.


Condition Intervention
Stroke
Cognitive Disorders
Behavioral Disorders
Behavioral: French adaptation of NINDS-CSN battery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Post-stroke Cognitive Impairment and Dementia: Frequency and Anatomical Correlates With the French Version of the NINDS-Canadian Stroke Network Battery

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • determine the frequency of cognitive and behavioral disorders 6 months post-stroke assessed with this new NINDS-Canadian Stroke Network battery [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    deficit (as compared with control performance) on battery of tests assessing instrumental (oral naming, copy of complex figure)and executive fucntions (verbal fluency, Trail Making, reaction time tests), episodic memory for verbal and visual materials and behavioral changes


Secondary Outcome Measures:
  • determine the proportion of patients with dementia [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    composite index including memory and cognitive disorders and decline in every day life activities

  • determine the value of cognitive screening tests [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    performance on MiniMental State Examination and Montreal Cognitive Assessment


Estimated Enrollment: 302
Study Start Date: August 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: French adaptation of NINDS-CSN battery
    • clinical: post-stroke neurological follow-up assessment
    • neuropsychological: comprising the NINDS-Canadian Stroke Network neuropsychological battery
    • MRI
Detailed Description:
  • Context In western countries, one in three subjects will experience a stroke, dementia or both. Recent studies have shown the major role of vascular risk factors and stroke in cognitive disorders and dementia. Poststroke cognitive and behavioral disorders are characterized by the prominence of action slowing, executive function disorders and apathy. They are due to vascular lesions or to associated pathology, mainly Alzheimer's disease. In order to determine diagnosis criteria of Vascular Cognitive Impairment, it is necessary to develop a standardized assessment of post-stroke cognitive and behavioral disorders (Hachinski et al Stroke 2006; 37; 2220-2241). For this purpose, the NINDS and the Canadian Stroke Network have jointly developed a specific standardized battery which is currently under validation. Its use in France requires first a normalization of some tests in French speaking healthy controls. This study is supported by the SFNV (French NeuroVascular Society) and GRECO.
  • Primary Objectives of the project: to determine the frequency of cognitive and behavioral disorders 6 months post-stroke assessed with this new NINDS-Canadian Stroke Network battery Primary endpoints: disorders on cognitive tests and on behavioral and depression questionnaires (defined by performance outside normal ranges determined in healthy controls);
  • Population Patients consecutive French-speaking patients with an informant assessed 6 months post-stroke and free from mental retardation, psychosis, illiteracy, previously diagnosed dementia, comorbidity known to impair cognitive abilities, MRI contraindication or refusal to participate.

Controls from the general population not presenting any condition known to impair cognitive abilities stratified according to age and schooling levels

  • Design Prospective multicenter study comparing performance of patients and controls Sample size: the frequencies of cognitive and behavioral disorders are considered as significantly different if the null hypothesis (lack of difference between groups at the 0.05 quantile) is rejected. Considering that each patient is matched with 3 controls, it will be necessary to evaluate 302 patients with the battery 6 months poststroke and 906 controls to detect a difference between groups of at least 5% with α risk =0.05 and power= 80%. In addition, the inclusion of 302 patients allows to determine the frequency of impaired patients with a CI95% ≤12%.
  • Feasibility: based on a previous similar study, 50 stroke patients (range 40-60) and 150 controls (range: 100-200) will be included per year in the University Hospital of Amiens. Thus 10 centers with similar inclusion rates will be able to include 302 patients and 906 controls within 3 years.
  • Secondary objectives: (1) to determine the frequency of poststroke dementia; (2) to determine the frequency of cognitive disorders on screening tests; (3) to examine correlations between cerebral MRI and cognitive impairment; (4) to determine correlations between cognitive disorders and activities of daily living.

Secondary endpoints: (1) dementia (DSMIV and NINDS-AIREN criteria); (2) screening tests (MiniMental Status Examination, Montreal Cognitive Assessment);(3) MRI abnormalities (cerebral atrophy, white matter abnormalities, stroke type, stroke volume and location) using 3D T1-weighted (axial bicommissural plane), T2-weighted (coronal plan), FLAIR, gradient-echo, diffusion-weighted (with calculation of the apparent diffusion coefficient) performed at 6 months post-stroke at the same time than the cognitive assessment; (4) disability in activities of daily living (Rankin scale, Barthel index, Instrumental Activities of Daily Living).

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Patients:management at the acute phase (duration < 30 days) of stroke visualized by imaging, age between 40 and 80 years, French-speaking, reliable informant, agreeing to participate in the study.
  • Controls: derived from the general population and consenting to participate in the study.

Exclusion criteria:

  • Patients: mental retardation, illiteracy, known dementia, schizophrenia or psychosis or history of psychiatric illness requiring a stay for > 2 days in a psychiatry unit, comorbidities affecting cognition, persistent disturbance of consciousness, contraindication to MRI.
  • Controls: illiteracy, deficit on MMSE, visual, auditory or motor deficit, history of brain disease or psychiatric illness (schizophrenia or other psychosis) or ongoing psychiatric illness (depression or other) currently requiring treatment or requiring a stay > 2 days in psychiatry unit or anxiety requiring more than one medication at the present time, alcoholism, opiate or illicit drug use < 3 months, ongoing antidepressant or antiepileptic treatment, recent anxiolytic or hypnotic treatment, general anaesthesia < 3 months, history of heart surgery with cardiopulmonary bypass
  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: NCT01339195

Contacts
Contact: Olivier Godefroy, PhD-MD ++33322668240 godefroy.olivier@chu-amiens.fr
Contact: Martine Roussel, PhD ++33322667813 roussel.martine@chu-amiens.fr

Locations
France
CHRU Lille Not yet recruiting
Lille, Pas-de-calais, France, 59000
Contact: Hilde Henon, MD    +33 3 20 44 68 14    hilde.henon@chru-lille.fr   
Contact: Florence PASQUIER, PhD       florence.pasquier@chru-lille.fr   
Principal Investigator: Hilde Henon, MD         
CHU Amiens Recruiting
Amiens, Picardie, France, 80000
Contact: Olivier Godefroy, MD-PhD    ++33322668240    godefroy.olivier@chu-amiens.fr   
Contact: Martine Roussel, PhD    ++33322668240    roussel.martine@chu-amiens.fr   
Principal Investigator: Claire leclerc, MD         
Principal Investigator: martine roussel, neuropsy         
Sub-Investigator: Jean-Marc Bugnicourt, MD         
Sub-Investigator: Candice PICARD, MD         
Sub-Investigator: Sandrine CANAPLE, MD         
Sub-Investigator: Chantal LAMY, MD         
CHU Brest Not yet recruiting
Brest, France, 29200
Contact: Serge Timsit, PhD    +33 2 98 34 73 00    serge.timsit@chu-brest.fr   
Contact: François-Mathias MERRIEN, MD    +33 2 98 34 73 00    francois-mathia.merrien@chu-brest.fr   
Sub-Investigator: Philippe Goas, MD         
Principal Investigator: Serge Timsit, PhD         
Sub-Investigator: François-Mathias MERRIEN, MD         
CHU Dijon Not yet recruiting
Dijon, France, 21000
Contact: Maurice Giroud, PhD-MD    +33 3 80 29 37 53    maurice.giroud@chu-dijon.fr   
Contact: Olivier ROUAUD, MD    +33 3 80 29 57 80    olivier.rouaud@chu-dijon.fr   
Principal Investigator: Maurice Giroud, PhD         
Sub-Investigator: Olivier Rouaud, MD         
CH La Rochelle Recruiting
La rochelle, France, 17000
Contact: Claudine Nedelec, MD    05 46 45 51 49    claudine.nedelec@ch-larochelle.fr   
Contact: Xavier VANDAMME, MD    +33546455235    xavier.vandamme@ch-larochelle.fr   
Principal Investigator: Claudine Nedelec, MD         
Sub-Investigator: Xavier Vandamme, MD         
HIA Val de Grâce Recruiting
Paris, France, 75000
Contact: Herve Taillia, PhD-MD    +33 1 40 51 41 01    herve.taillia@santarm.fr   
Contact: Anne-Emmanuelle ARDISSON, Neuropsy    +33 1 40 51 41 34    aeardisson@hotmail.com   
Principal Investigator: Herve Taillia, PhD         
CHU Saint Etienne Recruiting
Saint Etienne, France, 42000
Contact: Catherine THOMAS, PhD    +334 77 12 78 05    catherine.thomas@chu-st-etienne.fr   
Contact: Pierre GARNIER, MD    +334 77 12 78 05    pierre.garnier@chu-st-etienne.fr   
Principal Investigator: Catherine Thomas, PhD         
Sub-Investigator: Pierre Garnier, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Study Chair: Olivier Godefroy, PhD-MD CHU Amiens
Principal Investigator: Hilde Henon, MD CHRU Lille
Principal Investigator: Hervé Taillia, PhD-MD HIA val de grace
Principal Investigator: Serge Timsit, PhD-MD CHU Brest
Principal Investigator: Claudine Nedelec, MD CH La Rochelle
Principal Investigator: catherine thomas, MD CHU Saint Etienne
Principal Investigator: Maurice Giroud, PhD-MD CHU Dijon
  More Information

No publications provided by Centre Hospitalier Universitaire, Amiens

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01339195     History of Changes
Other Study ID Numbers: PI10-PR-GODEFROY, 2010-A00657-32
Study First Received: February 22, 2011
Last Updated: December 5, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Dementia
Alzheimer disease
stroke
cognitive impairment

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

ClinicalTrials.gov processed this record on October 20, 2014