Copeptin and the S-100b Protein in Stroke

NCT03974464 | Completed

• 1 other identifier: vertigo
• Study Type: observational
• Target: 151
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vertigo, Peripheral; Vertigo, Brain Stem; Vertigo; Central; Vertigo; Cerebral

Keywords

vertigo; stroke; copeptin; S-100b protein; biomarkers

Outcome Measures

Primary Outcomes (1)

• Show that the negativity of S-100b protein and copeptin eliminates stroke in the face of vertigo

  negative predictive value of the S-100b protein and copeptin combination

  1 hour

Interventions

copeptin, PS100 DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Poitiers University Hospital: lead

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)

MeSH Terms

Conditions

Vertigo; Stroke; Diabetes Insipidus

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: June 5, 2019
• Study Start: May 1, 2016
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: June 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share