- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07287891
Lost in the Labyrinth: Predicting Central Neurological Causes of Vertigo Dizziness and Unsteadiness in the Emergency Department. A Multicentre Cross-sectional Observational Study (VERTIGO)
December 4, 2025 updated by: Marco Bonzano, Fondazione IRCCS Policlinico San Matteo di Pavia
This study will assess the sensitivity and specificity of the bedside examination algorithm performed by ED physicians.
Finally, it aims to identify predictors of a central cause of the symptoms.
This will consequently reduce the rate of misdiagnosis as well as the costs and length of stay due to inappropriate neuroimaging.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
825
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marco Bonzano, MD
- Phone Number: +390382502039
- Email: m.bonzano@smatteo.pv.it
Study Locations
-
-
Pavia
-
Pavia, Pavia, Italy, 27100
- Recruiting
- SC Pronto Soccorso e Medicina d'Urgenza, Fondazione IRCCS Policlinico San Matteo
-
Contact:
- Marco Bonzano, MD
- Phone Number: +390380502039
- Email: m.bonzano@smatteo.pv.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients presenting at the ED with vertigo, dizziness or unsteadiness
Description
Inclusion Criteria:
- Patients presenting at the ED with vertigo, dizziness or unsteadiness
- >= 18 years of age
- Patients able to give their consent
Exclusion Criteria:
- Patients with dementia
- Bedridden patients (for causes other than the current symptoms)
- Patients with obvious neurological findings presenting with vertigo but with suspected stroke at triage
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients presenting at the ED with vertigo, dizziness, and unsteadiness
Patients presenting to the ED with vertigo/ dizziness
|
ED visit comprehensive of bedside examination of vertigo performed by trained EP or emergency medicine residents
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The AUC of the bedside examination algorithm performed by ED physicians
Time Frame: up to 36 months
|
up to 36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
identification of predictors of true positive patients
Time Frame: up to 36 months
|
Predictors of true positive patients can help to stratify patients with vertigo for the risk of stroke.
|
up to 36 months
|
|
evaluation of number of neuroimaging tests (TC and angio-TC) performed to patients with vertigo in the ED.tests performed
Time Frame: up to 36 months
|
to study the use of ED resources for these patients in terms of number of neuroimaging tests performed.
|
up to 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 26, 2024
Primary Completion (Estimated)
February 26, 2027
Study Completion (Estimated)
February 26, 2027
Study Registration Dates
First Submitted
December 4, 2025
First Submitted That Met QC Criteria
December 4, 2025
First Posted (Actual)
December 17, 2025
Study Record Updates
Last Update Posted (Actual)
December 17, 2025
Last Update Submitted That Met QC Criteria
December 4, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VERTIGO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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