Study of Factors Influencing Post-stroke Dementia - Full Text View

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:

MedlinePlus related topics: Dementia

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

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 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 ] [ 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 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:	December 2020
Estimated Primary Completion Date:	December 2017 (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 (Adult, Senior)
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


Responsible Party:	University Hospital, Lille
ClinicalTrials.gov Identifier:	NCT01330160 History of Changes
Other Study ID Numbers:	2008_42/0907 2008/API1901 2009-A00141-56
Study First Received:	October 1, 2010
Last Updated:	May 12, 2016
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 Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases	Neurocognitive Disorders Mental Disorders Vascular Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 26, 2016

Study of Factors Influencing Post-stroke Dementia (strokdem)