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Clinical Biological and Pharmacological Factors Influencing Stroke Outcome (biostroke)

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ClinicalTrials.gov Identifier: NCT00763217
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : May 13, 2015
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease
Stroke

Detailed Description:

In the cohort, the severity of stroke (NIHSS) will be correlated with :

  • clinical factors,
  • pharmacological factors,
  • biological factors (inflammatory markers, hemostasis...)

Study Design
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Study Type : Observational
Actual Enrollment : 550 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Clinical, Biological and Pharmacological Markers of Stroke Outcome
Study Start Date : June 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2012
Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
stroke patient cohort
Patients with an hemispheric ischemic or hemorrhage stroke hospitalized during the 48h following the beginning of stroke


Outcome Measures
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Primary Outcome Measures :
  1. severity of stroke measured by NIH severity score [ Time Frame: inclusion, day7, month3, year3 ]

Secondary Outcome Measures :
  1. clinical, pharmacological and biological (metabolic, inflammation, hemostasis...) cognitive status [ Time Frame: inclusion and year3 ]

Biospecimen Retention:   Samples Without DNA
whole blood and serum

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 )
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 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