NCT05002400Completed
Evaluation of the PS100B for the Diagnostic of Stroke With Patients Out of Delay for Thrombolysis or Thrombectomy
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
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 Patients included have a sample of blood withdrawn, in order to measure PS100B blood level.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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 179 (actual)
- First submitted
- 4 Aug 2021
- Start date
- 2 Sept 2021
- Primary completion date
- 12 Dec 2025
- Lead sponsor
- Poitiers University Hospital
- Diseases
- Stroke
- NCT number
- NCT05002400
What you commit to
- Study type: Observational
- Participants enrolled: 179
- From 2 Sept 2021 to the primary completion date, 12 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Henri Mondor Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
| C.H.U. de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.