- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01330160
Study of Factors Influencing Post-stroke Dementia (strokdem)
Characterization of Clinical, Biological, Morphological and Pharmacological Factors Influencing Occurrence of Dementia or Cognitive Disorders After Stroke
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Régis Bordet, MD PhD
- Phone Number: +33 (0)3 20 44 54 49
- Email: regis.bordet@chru-lille.fr
Study Contact Backup
- Name: Didier Leys, MD PhD
- Phone Number: +33 (0)3 20 44 68 14
- Email: dleys@chru-lille.fr
Study Locations
-
-
-
Amiens, France, 80000
- Active, not recruiting
- Amiens University Hospital
-
Caen, France, 14000
- Active, not recruiting
- CAEN university Hospital
-
Lille, France, 59045
- Recruiting
- Lille University Hospital
-
Contact:
- Régis Bordet, MD PhD
- Phone Number: +33 (0)3 20 44 54 49
- Email: regis.bordet@chru-lille.fr
-
Contact:
- Didier Leys, MD PhD
- Phone Number: +33 (0)3 20 44 68 14
- Email: dleys@chru-lille.fr
-
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, France, 76000
- Recruiting
- Rouen University Hospital
-
Contact:
- Didier Hannequin, MD PhD
- Email: Didier.Hannequin@chu-rouen.fr
-
Principal Investigator:
- Didier Hannequin, MD PhD
-
Sub-Investigator:
- Evelyne Guegan-Massardier, MD
-
Sub-Investigator:
- Aude Triquenot-Bagan, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
60 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cognitive impairment
Time Frame: 36 months
|
Impairment of some tests of cognitive battery without significant impairment in activities of daily living
|
36 months
|
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 |
6 months
|
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 |
12 months
|
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 |
36 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Regis Bordet, MD PhD, Lille University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008_42/0907
- 2008/API1901 (OTHER_GRANT: PHRC)
- 2009-A00141-56 (OTHER: ID-RCB number, ANSM)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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