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Copeptin and the S-100b Protein in Stroke

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ClinicalTrials.gov Identifier: NCT03974464
Recruitment Status : Completed
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Brief Summary:
This study evaluated the value of using copetin and protein S 100 b to eliminate the diagnosis of stroke in patients presenting with vertigo in emergency departments. All patients benefited from the S 100b protein assay, copeptin and brain MRI.

Condition or disease Intervention/treatment
Vertigo, Peripheral Vertigo, Brain Stem Vertigo; Central Vertigo; Cerebral Diagnostic Test: copeptin, PS100

Detailed Description:

Vertigo is a frequent reason for visiting emergency departments. Differentiating stroke from other causes is challenging for physicians. The role of biomarkers has been poorly assessed. Evaluators evaluated whether copeptin and S100b protein assessment, alone or in combination, could rule out stroke in patients visiting emergency departments for vertigo.

Evaluators included patients visiting the adult emergency departments of a French university hospital for a new episode of vertigo evolving for less than 72 hours. All patients underwent standardized physical examination (HINT [Head Impulse test, Nystagmus, test of skew deviation] maneuvers), copeptin and S-100b protein measurement and injected brain imaging. Stroke diagnosis involved diffusion-weighted magnetic resonance imaging or, if not available, neurological examination and contrast brain CT scan compatible with the diagnosis.


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Study Type : Observational
Actual Enrollment : 151 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Value of Copeptin and the S-100b Protein Assay in Ruling Out the Diagnosis of Stroke-induced Dizziness Pattern in Emergency Departments
Actual Study Start Date : May 1, 2016
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: copeptin, PS100

    Age, sex and time between dizziness onset and ED visit were collected using Resurgences® software. PS100 concentrations were measured on serum samples by electro-chemiluminescence assay. Copeptin concentrations were measured on serum samples by the Kryptor method. The positivity threshold for copeptin was set at strictly above 10 pmol/L and that of PS100 was set at strictly above 0.105 μmol/L.

    And after, we compared results with results of brain imaging: Magnetic Resonance Imaging alone, CT scan alone or both. Depending on clinical presentation, the imaging tests were performed during ED stay, during hospitalization or externally. Presence or absence of stroke was established on diffusion-weighted brain MRI . In case of normal contrast CT alone, a specialized opinion should exclude the need for diffusion-weighted MRI according to clinical presentation.



Primary Outcome Measures :
  1. Show that the negativity of S-100b protein and copeptin eliminates stroke in the face of vertigo [ Time Frame: 1 hour ]
    negative predictive value of the S-100b protein and copeptin combination


Biospecimen Retention:   Samples Without DNA
PS100 concentrations were measured on serum samples by electro-chemiluminescence assay (Roche, Mannheim, Germany). Copeptin concentrations were measured on serum samples by the Kryptor method (Thermo Scientific, Hennigsdorf, Germany)


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
One hundred and fifty-one patients were included, of whom 16 were secondarily excluded (lost to follow-up n=1, missing biomarkers n=9, missing MRI n=6)(Figure 1). A majority of the remaining 135 patients were women (n=79, 59%) with an average age of 62 years . Specialized advice on the origin of dizziness was sought from ENT and/or neurologist in 102 (76%) of cases. Patients received brain diffusion-weighted MRI alone in 74 cases, contrast brain CT alone in 11 cases and a combination of MRI and CT in 50 cases. In 122 patients (90%), vertigo was not related to stroke.
Criteria

Inclusion Criteria:

  • We included patients 18 years of age or older, visiting the ED for a new episode of dizziness evolving less than 72 hours and having given written consent to participate in the study

Exclusion Criteria:

  • Patients without brain imaging (diffusion-weighted magnetic resonance imaging (MRI) or contrast CT scan compatible with the diagnosis) were excluded.

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03974464     History of Changes
Other Study ID Numbers: vertigo
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Poitiers University Hospital:
vertigo
stroke
copeptin
S-100b protein
biomarkers

Additional relevant MeSH terms:
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Vertigo
Diabetes Insipidus
Dizziness
Nervous System Diseases
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Signs and Symptoms
Sensation Disorders
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs