Evaluation of the PS100B for the Diagnostic of Stroke With Patients Out of Delay for Thrombolysis or Thrombectomy

Study Overview
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Brief Summary
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Numerous patients are addressed to the Emergency Department for unspecific symptoms which can evoke a stroke, such as vertigo, isolated motor deficit, behavior disorder. For these patients, when they arrive out of time for specific treatments such as thrombolysis and thrombectomy, the cerebral imagery is not an emergency, but necessary to confirm or invalidate the diagnostic of stroke. If a biomarker could exclude the diagnostic of stroke, we could avoid an imagery for these patients. PS100B is a biomarker whose blood level increases in case of stroke. It has already proven a prognostic value. Until now, it hasn't proven a diagnostic value because it take a few hours to increase in the blood. It could have in prognostic value for patients who have the symptoms for more than 24 hours. STROkE is a diagnostic, prospective, monocentric study, conducted at University Hospital Center of Poitiers (France). The aim is to determine the value of PS100B to exclude the diagnostic of a stroke in case of evocative symptoms, for patients who are out of delay for a thrombolysis or a thrombectomy. Patients eligible are the ones who present to the emergency department with symptoms evocative of stroke for more than 24 hours and less than 4 days. Patients included have a sample of blood withdrawn, in order to measure PS100B blood level. The diagnostic of stroke is than confirmed or excluded by an adjudication comity, who are unaware of the result of PS100B blood level. The diagnostic value of PS100B is determined with the help of a ROC curve.

Official Title
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Evaluation of the PS100B for the Diagnostic of Stroke With Patients Out of Delay for Thrombolysis or Thrombectomy

Conditions
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Stroke

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting at the Emergency Department of the University Hospital Center of Poitiers for the following symptoms, which last since more then 24 hours et less then 4 days : sensitive or motor deficit of one or several limbs facial paralysis impairment of speech dysarthria vertigo impairment of vision oculomotor disorder diplopia free patient, without guardianship or curatorship, or subordination patient not objecting to research Exclusion Criteria: head trauma that occured less then 15 days ago known cerebral mass or melanoma refusal to participate in research patient benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection pregnant and/or breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic value of PS100B | Determine the best couple sensibility / specificity of the blood value of PS100B with the help of a Receive Operating Charasteristics (ROC) curve for patients who present with symptoms evocative of stroke since more than 24 hours and less than 4 days | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value of PS100B for ischemic strokes and hemorrhagic strokes | Comparison of the mean value of PS100B between patients with ischemic strokes and hemorrhagic strokes | 1 day | 
| Value of PS100B and time delay since the beginning of the symptoms | Stratification of the value of PS100B with the delay of apparition of the symptoms and realization of the blood sample | 1 day | 
| Prognostic value of PS100B | Comparison of the value of PS100B and the patient's outcomes 28 days after inclusion. The patient's outcome will be assessed as follow : hospitalization, death and self-rated health perception. The self-rated health perception will be assessed with the scale EuroQOL (EQ)-5D-5L. The scale EQ-5D-5L is composed of : a score on 5 levels : from 1 to 3 (no problem) and 4 to 5 (with problems) analogic scale from 0 to 100 (0 = worst health perception ; 100 = best health perception) | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PS100B, stroke, out of delay, diagnostic