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

NCT ID: NCT05002400

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 179 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-02
• Study Completion Date: 2025-12-12

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 Patients included have a sample of blood withdrawn, in order to measure PS100B blood level.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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Henri MONDOR

Créteil, , France

C.H.U. de Poitiers

Poitiers, , France

Countries

France

Other Identifiers

STROkE

Identifier Type: -

Identifier Source: org_study_id