Clinical Biological and Pharmacological Factors Influencing Stroke Outcome

Stroke Clinical Trial

— biostroke  

Official title:

Characterization of Clinical, Biological and Pharmacological Markers of Stroke Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763217
• Other study ID #: CP 05/15
• Secondary ID: PHRC 2004/1901
• Status: Completed
• Phase: N/A
• First received: September 26, 2008
• Last updated: May 12, 2015
• Start date: June 2005
• Est. completion date: June 2012

Study information

• Verified date: May 2015
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Description:

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

• clinical factors,

• pharmacological factors,

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: June 2012
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
France	Lille University Hospital - Service de Neurologie vasculaire	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of stroke measured by NIH severity score		inclusion, day7, month3, year3	No
Secondary	clinical, pharmacological and biological (metabolic, inflammation, hemostasis...) cognitive status		inclusion and year3	No