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: May 12, 2015

Last verified: May 2015

History of Changes

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 (Adult, Senior)
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


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:	May 12, 2015
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:


Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases	Nervous System Diseases Vascular Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 27, 2016

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