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CompletedNCT05002400Updated Jan 6, 2026

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

An observational study in Stroke, sponsored by Poitiers University Hospital. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by Poitiers University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
179
Ages
18 Years and older
Sex
All
01

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 Patients included have a sample of blood withdrawn, in order to measure PS100B blood level.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

02

Conditions studied

  • Stroke

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Keywords

  • PS100B
  • stroke
  • out of delay
  • diagnostic
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 179 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Poitiers University Hospital is the lead sponsor of 310 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
179 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

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

    Time frame: 1 day

Secondary outcomes

  1. Value of PS100B for ischemic strokes and hemorrhagic strokes

    Comparison of the mean value of PS100B between patients with ischemic strokes and hemorrhagic strokes

    Time frame: 1 day

  2. 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

    Time frame: 1 day

  3. 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)

    Time frame: 28 days

07

Study locations

2 sites
  • CHU Henri MONDOR
    Créteil, 94000, France
  • C.H.U. de Poitiers
    Poitiers, 86000, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05002400
Lead sponsor
Poitiers University Hospital
Responsible party
Sponsor
First posted
Aug 12, 2021
Start date
Sep 2, 2021
Primary completion
Dec 12, 2025
Completion
Dec 12, 2025
Last update
Jan 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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