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Clinical Biological and Pharmacological Factors Influencing Stroke Outcome (biostroke)

This study has been completed.
Sponsor:
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: November 12, 2014
Last verified: November 2014
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical, pharmacological and biological (metabolic, inflammation, hemostasis...) cognitive status [ Time Frame: inclusion and year3 ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT00763217     History of Changes
Other Study ID Numbers: CP 05/15, PHRC 2004/1901
Study First Received: September 26, 2008
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:
inflammation
coagulation
neuroprotection
drugs
clinical neurology
pharmacology
biological factors

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014