Study of Factors Influencing Post-stroke Dementia (strokdem)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified May 2017 by University Hospital, Lille
Sponsor:
University Hospital, Lille
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01330160
First received: October 1, 2010
Last updated: May 17, 2017
Last verified: May 2017
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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 |
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| 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
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
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
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 ) |
| Study First Received: | October 1, 2010 |
| Last Updated: | May 17, 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 |
ClinicalTrials.gov processed this record on May 22, 2017