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

NCT05002400 | Completed

• 1 other identifier: STROkE
• Study Type: observational
• Target: 179
• Locations: 1 country
• Sites: 2

Brief Summary

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 Patients included have a sample of blood withdrawn, in order to measure PS100B blood level.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.

Conditions

Stroke

Keywords

PS100B; stroke; out of delay; diagnostic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Value of PS100B for ischemic strokes and hemorrhagic strokes

  1 day

• Value of PS100B and time delay since the beginning of the symptoms

  1 day

• Prognostic value of PS100B

  28 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients presenting at the Emergency Department of the University Hospital Center of Poitiers for symptoms evocative of stroke for more then 24 hours and less then 4 days, that fit the inclusion and exclusion criteria

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (2)

CHU Henri MONDOR

Créteil, 94000, France

Location

C.H.U. de Poitiers

Poitiers, 86000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample in order to measure the value of PS100B

MeSH Terms

Conditions

Stroke; Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 12, 2021
• Study Start: September 2, 2021
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

FR (2)