Clinical trial NCT05002400: Evaluation of the PS100B for the Diagnostic of Stroke With Patients Out of Delay for Thrombolysis or Thrombectomy
Official title: Evaluation of the PS100B for the Diagnostic of Stroke With Patients Out of Delay for Thrombolysis or Thrombectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: PS100B
stroke
out of delay
diagnostic
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 381
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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 Patients included have a sample of blood withdrawn, in order to measure PS100B blood level.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


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

Primary outcomes:
measure: Diagnostic value of PS100B
timeFrame: 1 day
Secondary outcomes:
measure: Value of PS100B for ischemic strokes and hemorrhagic strokes
timeFrame: 1 day
measure: Value of PS100B and time delay since the beginning of the symptoms
timeFrame: 1 day
measure: Prognostic value of PS100B
timeFrame: 28 days
Other outcomes:
Locations:
city: Créteil
country: France
facility: CHU Henri MONDOR
city: Poitiers
country: France
facility: C.H.U. de Poitiers
Study officials:
References: