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Published on: July 14, 2023
Protocol for a prospective interventional trial to develop a diagnostic index test for stroke as a cause of vertigo,
Ken Möhwald1, Stanislavs Bardins1, Hans-Helge Müller2
1German Center for Vertigo and Balance Disorders, DSGZ, University Hospital, Ludwig-Maximilians-Universität München, Munich, Germany.
Insights
Diagnosing stroke in emergency room patients with acute vertigo is challenging. This study aims to develop a diagnostic index test to accurately identify stroke risk, reducing unnecessary hospital admissions.
Area of Science:
- Neurology
- Emergency Medicine
- Diagnostic Imaging
Background:
- Distinguishing stroke from other causes of acute vertigo, dizziness, and imbalance in the emergency room (ER) presents a significant clinical challenge.
- A large proportion of patients admitted to stroke units for these symptoms are ultimately found not to have had a stroke, leading to substantial healthcare costs.
- There is a critical need for a reliable diagnostic tool to identify patients at high risk of stroke presenting with acute vertigo and imbalance.
Purpose of the Study:
- To develop and validate a diagnostic index test for the early identification of stroke in patients presenting with acute vertigo and imbalance in the ER.
- To improve the accuracy of stroke diagnosis in the ER setting, thereby reducing healthcare burden and optimizing patient care.
Main Methods:
- Eligible patients presenting with acute onset vertigo, dizziness, postural imbalance, or double vision within 24 hours were enrolled.
- Standardized neuro-ophthalmological and physiological testing, including video-oculography and mobile posturography, was performed in the ER (EMVERT block 1).
- Standardized MRI was conducted within 10 days as a reference standard to confirm stroke (EMVERT block 2), with data from both blocks used to devise the diagnostic index test.
Main Results:
- The study is designed to compare the results of initial ER testing (block 1) with MRI findings (block 2).
- The comparison will enable the development of a diagnostic index test with high specificity and sensitivity.
- This test aims to accurately predict the risk of stroke in patients presenting with acute vertigo and imbalance in the ER.
Conclusions:
- The developed diagnostic index test is expected to significantly improve the accuracy of stroke identification in the ER.
- This tool has the potential to reduce unnecessary hospital admissions and associated healthcare costs.
- The study will provide a valuable instrument for clinicians managing patients with acute vertigo and imbalance.
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.
