StrokeNCT05002400
Evaluation of the PS100B for the Diagnostic of Stroke With Patients Out of Delay for Thrombolysis or Thrombectomy
An observational study of Stroke, run by Poitiers University Hospital at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 179 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Sep 2021to 12 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Show all 11Show fewer
- impairment of vision
- oculomotor disorder
- diplopia
- free patient, without guardianship or curatorship, or subordination
- patient not objecting to research
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Henri MONDOR
Créteil, 94000
C.H.U. de Poitiers
Poitiers, 86000
About this study
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.
Read more
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
- Medical subject headings
- Stroke, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (3)
Value of PS100B for ischemic strokes and hemorrhagic strokes
Comparison of the mean value of PS100B between patients with ischemic strokes and hemorrhagic strokes
Measured: 1 day
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
Measured: 1 day
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)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start2 Sep 2021
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002400
- Sponsor's protocol ID
- STROkE
- Status last verified
- Jan 2026
- First submitted
- 4 Aug 2021
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the PS100B for the Diagnostic of Stroke With Patients Out of Delay for Thrombolysis or Thrombectomy
- ClinicalTrials.gov ID
- NCT05002400
- Acronym / sponsor ID
- STROkE
- Conditions
- Stroke
- Keywords
- PS100B, stroke, out of delay, diagnostic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic value of PS100B
Time frame: 1 day
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
3 secondary outcomes
Value of PS100B for ischemic strokes and hemorrhagic strokes
Time frame: 1 day
Value of PS100B and time delay since the beginning of the symptoms
Time frame: 1 day
Prognostic value of PS100B
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Poitiers University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic value of PS100B (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.