Study of Factors Influencing Post-stroke Dementia (strokdem)
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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 |
- 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.
- 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 2015 (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 |
Patients without dementia displaying an hemispheric ischemic or hemorrhagic stroke hospitalized during the 72h following the beginning of stroke
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01330160
| 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 | |
| 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 | |
| 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: | 2008_42/0907, 2008/API1901, 2009-A00141-56 |
| Study First Received: | October 1, 2010 |
| Last Updated: | November 12, 2014 |
| 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:
|
Cerebrovascular Disorders Dementia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on March 03, 2015