Evaluating a blood biomarker for diagnosing stroke in patients with delayed symptoms
Evaluation of the PS100B for the Diagnostic of Stroke With Patients Out of Delay for Thrombolysis or Thrombectomy
This study is testing if a blood test for the PS100B biomarker can help doctors decide if patients with stroke-like symptoms that started more than a day ago actually had a stroke, which could save them from unnecessary scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 381 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Poitiers University Hospital Academic / other |
| Locations | 2 sites (Créteil and 1 other locations) |
| Trial ID | NCT05002400 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the diagnostic value of the PS100B biomarker in patients presenting with stroke-like symptoms that have persisted for more than 24 hours but are outside the window for thrombolysis or thrombectomy. By measuring the levels of PS100B in the blood, the study seeks to determine if this biomarker can effectively exclude a stroke diagnosis, potentially reducing the need for unnecessary imaging procedures. Conducted at the University Hospital Center of Poitiers, the study focuses on patients who exhibit specific neurological symptoms upon arrival at the emergency department.
Who should consider this trial
Good fit: Ideal candidates are patients presenting with specific neurological symptoms lasting between 24 hours and 4 days at the emergency department.
Not a fit: Patients with recent head trauma, known cerebral masses, or those under legal protection will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more efficient diagnostic process for stroke, reducing unnecessary imaging and associated healthcare costs.
How similar studies have performed: While the PS100B biomarker has shown prognostic value, its diagnostic application is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / 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: * 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
Where this trial is running
Créteil and 1 other locations
- CHU Henri MONDOR — Créteil, France (Recruiting)
- C.H.U. de Poitiers — Poitiers, France (Recruiting)
Study contacts
- Study coordinator: Jérémy GUENEZAN
- Email: jeremy.guenezan@chu-poitiers.fr
- Phone: 0549444488
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.