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Protocol for a prospective interventional trial to develop a diagnostic index test for stroke as a cause of vertigo, dizziness and imbalance in the emergency room (EMVERT study).

Identifieur interne : 000515 ( Main/Exploration ); précédent : 000514; suivant : 000516

Protocol for a prospective interventional trial to develop a diagnostic index test for stroke as a cause of vertigo, dizziness and imbalance in the emergency room (EMVERT study).

Auteurs : Ken Möhwald [Allemagne] ; Stanislavs Bardins [Allemagne] ; Hans-Helge Müller [Allemagne] ; Klaus Jahn [Allemagne] ; Andreas Zwergal [Allemagne]

Source :

RBID : pubmed:29018076

Descripteurs français

English descriptors

Abstract

INTRODUCTION

Identifying stroke as a cause of acute vertigo, dizziness and imbalance in the emergency room is still a clinical challenge. Many patients are admitted to stroke units, but only a minority will have strokes. This imposes a heavy financial burden on the healthcare system. The aim of this study is to develop a diagnostic index test to identify patients with a high risk of having a stroke as the cause of acute vertigo and imbalance.

METHODS AND ANALYSIS

Patients with acute onset of vertigo, dizziness, postural imbalance or double vision within the last 24 hours lasting for at least 10 min are eligible to be included in the study. Patients with clinically proven peripheral or central aetiology will be excluded. In the emergency room, all enrolled patients will undergo standardised neuro-ophthalmological/physiological testing (including video-oculography, mobile posturography, measurement of subjective visual vertical) (EMVERT block 1). Within 10 days, standardised MRI will be performed as a reference test to identify stroke (EMVERT block 2). Data from EMVERT block 2 will be compared with results from block 1 in order to devise a diagnostic index test with a high specificity and sensitivity to predict the risk of stroke in the emergency room.

ETHICS AND DISSEMINATION

The study was approved by the ethics committee of the University of Munich and will be conducted according to the Guideline for Good Clinical Practice, the Federal Data Protecting Act and the Helsinki Declaration of the World Medical Association in its recent version. Study results are expected to be published in international peer-reviewed journals and will be presented at international conferences.

TRIAL REGISTRATION NUMBER

German Clinical Trial Register: DRKS00008992; Universal trial number: U1111-1172-8719); pre-results.


DOI: 10.1136/bmjopen-2017-019073
PubMed: 29018076
PubMed Central: PMC5652468


Affiliations:


Links toward previous steps (curation, corpus...)


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<term>Diplopia (diagnosis)</term>
<term>Diplopia (etiology)</term>
<term>Dizziness (diagnosis)</term>
<term>Dizziness (etiology)</term>
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<b>INTRODUCTION</b>
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<p>Identifying stroke as a cause of acute vertigo, dizziness and imbalance in the emergency room is still a clinical challenge. Many patients are admitted to stroke units, but only a minority will have strokes. This imposes a heavy financial burden on the healthcare system. The aim of this study is to develop a diagnostic index test to identify patients with a high risk of having a stroke as the cause of acute vertigo and imbalance.</p>
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<p>
<b>METHODS AND ANALYSIS</b>
</p>
<p>Patients with acute onset of vertigo, dizziness, postural imbalance or double vision within the last 24 hours lasting for at least 10 min are eligible to be included in the study. Patients with clinically proven peripheral or central aetiology will be excluded. In the emergency room, all enrolled patients will undergo standardised neuro-ophthalmological/physiological testing (including video-oculography, mobile posturography, measurement of subjective visual vertical) (EMVERT block 1). Within 10 days, standardised MRI will be performed as a reference test to identify stroke (EMVERT block 2). Data from EMVERT block 2 will be compared with results from block 1 in order to devise a diagnostic index test with a high specificity and sensitivity to predict the risk of stroke in the emergency room.</p>
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<div type="abstract" xml:lang="en">
<p>
<b>ETHICS AND DISSEMINATION</b>
</p>
<p>The study was approved by the ethics committee of the University of Munich and will be conducted according to the Guideline for Good Clinical Practice, the Federal Data Protecting Act and the Helsinki Declaration of the World Medical Association in its recent version. Study results are expected to be published in international peer-reviewed journals and will be presented at international conferences.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>TRIAL REGISTRATION NUMBER</b>
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<p>German Clinical Trial Register: DRKS00008992; Universal trial number: U1111-1172-8719); pre-results.</p>
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<AbstractText Label="METHODS AND ANALYSIS" NlmCategory="UNASSIGNED">Patients with acute onset of vertigo, dizziness, postural imbalance or double vision within the last 24 hours lasting for at least 10 min are eligible to be included in the study. Patients with clinically proven peripheral or central aetiology will be excluded. In the emergency room, all enrolled patients will undergo standardised neuro-ophthalmological/physiological testing (including video-oculography, mobile posturography, measurement of subjective visual vertical) (EMVERT block 1). Within 10 days, standardised MRI will be performed as a reference test to identify stroke (EMVERT block 2). Data from EMVERT block 2 will be compared with results from block 1 in order to devise a diagnostic index test with a high specificity and sensitivity to predict the risk of stroke in the emergency room.</AbstractText>
<AbstractText Label="ETHICS AND DISSEMINATION" NlmCategory="UNASSIGNED">The study was approved by the ethics committee of the University of Munich and will be conducted according to the Guideline for Good Clinical Practice, the Federal Data Protecting Act and the Helsinki Declaration of the World Medical Association in its recent version. Study results are expected to be published in international peer-reviewed journals and will be presented at international conferences.</AbstractText>
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<CopyrightInformation>© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.</CopyrightInformation>
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