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Clinical Biological and Pharmacological Factors Influencing Stroke Outcome (biostroke)
This study has been completed.
Sponsor:
University Hospital, Lille
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT00763217
First received: September 26, 2008
Last updated: May 12, 2015
Last verified: May 2015
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Purpose
In a previous suty, we have demonstrated that prior transient ischemic attack, treatment lipid-lowering drug or physical activity are associated to a better outcome of stroke. The aim of the study is to understand the mechanisms of this preventive neuroprotection by establishing link between biomarkers and preventive and neuroprotective measures.To answer to the question, we conduct a cohort study of stroke patients.
| Condition |
|---|
| Stroke |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Characterization of Clinical, Biological and Pharmacological Markers of Stroke Outcome |
Further study details as provided by University Hospital, Lille:
Primary Outcome Measures:
- severity of stroke measured by NIH severity score [ Time Frame: inclusion, day7, month3, year3 ]
Secondary Outcome Measures:
- clinical, pharmacological and biological (metabolic, inflammation, hemostasis...) cognitive status [ Time Frame: inclusion and year3 ]
Biospecimen Retention: Samples Without DNA
whole blood and serum
| Enrollment: | 550 |
| Study Start Date: | June 2005 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
stroke patient cohort
Patients with an hemispheric ischemic or hemorrhage stroke hospitalized during the 48h following the beginning of stroke
|
Detailed Description:
In the cohort, the severity of stroke (NIHSS) will be correlated with :
- clinical factors,
- pharmacological factors,
- biological factors (inflammatory markers, hemostasis...)
Eligibility| Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Cohort of stroke patient
Criteria
Inclusion Criteria:
- ischemic or hemorrhage stroke
- hemispheric stroke
- stroke dating from less 48h
Exclusion Criteria:
- non hemispheric stroke
- malformative intracranial hemorrhage
- traumatic intracranial hemorrhage
- subarachnoidal hemorrhage
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00763217
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763217
Locations
| France | |
| Lille University Hospital - Service de Neurologie vasculaire | |
| Lille, France | |
Sponsors and Collaborators
University Hospital, Lille
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
| Principal Investigator: | 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: | NCT00763217 History of Changes |
| Other Study ID Numbers: |
CP 05/15 PHRC 2004/1901 ( Other Identifier: DHOS ) |
| Study First Received: | September 26, 2008 |
| Last Updated: | May 12, 2015 |
Keywords provided by University Hospital, Lille:
|
inflammation coagulation neuroprotection drugs |
clinical neurology pharmacology biological factors |
Additional relevant MeSH terms:
|
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on August 16, 2017