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AzTrials

VertigoUTRAVERANCT07421973

Prospective Registry of Vertigo Due to Vertebrobasilar Transient Attacks.

An observational study of Vertigo and Dizziness, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Vertigo and dizziness are common neurological complaints in the emergency department and may represent a wide spectrum of etiologies, including vertebrobasilar transient neurological attacks (VB-TNAs). Read more about this study

Who is it for?
Ages 18 years and older
How many people
400 participants
Where
1 siteBrazil
Study dates
1 May 2026to Oct 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults presenting with acute or transient episodes of vertigo, dizziness, or unsteadiness that suggest vertebrobasilar transient neurological attacks will be evaluated in emergency departments or outpatient neurotology/neurology settings. Participants will be prospectively enrolled based on predefined clinical criteria and followed longitudinally to assess diagnostic confirmation, clinical characteristics, treatment responses, and prognostic outcomes.

Who may be able to join

  • Episodic acute vertigo, dizziness or unsteadiness transient or in evolution, therefore, lasting <24 h
  • Such an episode may be isolated or associated with one or more of the following:
  • focal central neurological symptoms or severe postural instability;
  • new-onset, moderate-to-severe craniocervical pain; or
  • symptoms that are not better accounted for by another disease or disorder.

Who cannot join

  • Patients who present with findings of acute hemorrhage or ischemia on the cranial magnetic resonance imaging (MRI), including diffusion-weighted MRI (DWI-MRI) at recruitment;
  • Patients who also fulfill the diagnostic criteria for other neurotological diseases that may present acute or recurrent transient dizziness/Vertigo (Unilateral Vestibulopathy; benign paroxysmal positional vertigo; Meniére's disease; Vestibular Migraine; Vestibular Paroxysmia; Persistente Postural-Perceptual Dizziness; and Postural Hypotension;
  • Patients whose symptoms last more than 24 hours or who have evidence of sequelae during follow-up;
  • Patients with contraindications to any of the therapeutic options proposed by this study method;
  • Patients who have other symptoms during the follow-up that suggest another etiology of dizziness or vertigo;
  • Patients who do not complete the entire evaluation;
  • Patients who refuse to sign the informed consent form.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

ARLINDO C NETO, PhD contact

+5515996928584

aclimanetoent@gmail.com

Ji-Soo Kim, PhD contact

+82 31 787 7463

jisookim@snu.ac.kr

Brazil1 site
  • Hospital das Clínicas - University of São Paulo

    São Paulo, São Paulo, 05403900

    ARLINDO C NETO, PhD, +5515996928584, aclimanetoent@gmail.com

    Ji-Soo Kim, PhD, +82 31 787 7463, jisookim@snu.ac.kr

Other trials in Brazil

About this study

Official title: The UTRAVERA: a Multicenter Prospective Observational Investigation on Vertigo and Dizziness Due to Vertebrobasilar Transient Neurological Attacks - Diagnoses, Clinical Features, Treatment Responses, and Prognostic Factors.

Vertigo and dizziness are common neurological complaints in the emergency department and may represent a wide spectrum of etiologies, including vertebrobasilar transient neurological attacks (VB-TNAs). Distinguishing VB-TNAs, particularly vertebrobasilar transient ischemic attacks (VB-TIAs), from migraine-like and other non-vascular conditions is often challenging at first presentation due to the absence of specific biomarkers and overlapping clinical features. The UTRAVERA study is a multicenter, prospective, observational investigation designed to characterize the clinical features of patients presenting with acute transient vertigo or dizziness suspected to be VB-TNAs. The study will also evaluate diagnostic evolution over time, treatment responses, and prognostic factors associated with clinical outcomes.

Read the detailed description

The UTRAVERA (Unclassified Transient Vertiginous Attacks) study is a multicenter, prospective, observational cohort study designed in accordance with the SPIRIT 2025 Statement. The study aims to address diagnostic uncertainty in patients presenting to the emergency department with acute transient vertigo, dizziness, or unsteadiness lasting less than 24 hours, with no immediate evidence of stroke on neuroimaging.

The study focuses on the spectrum of vertebrobasilar transient neurological attacks (VB-TNAs), a clinical construct that encompasses transient vestibular symptoms with or without associated brainstem manifestations, such as diplopia, dysarthria, ataxia, sensory disturbances, or bilateral visual symptoms.

Initially, these episodes may be indistinguishable from vestibular migraine, atypical peripheral vestibular disorders, or other miscellaneous conditions, resulting in a diagnostic gray zone.

Adult patients presenting with transient vertigo or dizziness are prospectively enrolled and undergo standardized otologic, neurological, cardiovascular, and imaging evaluations, including diffusion-weighted MRI and vascular imaging of the vertebrobasilar circulation. Based on baseline findings and longitudinal follow-up, patients are classified into diagnostic categories, including VB-TIA, migraine-like disorder, miscellaneous causes, or unclassified attacks.

Follow-up assessments are performed at three and six months to evaluate diagnostic reclassification, symptom recurrence, treatment responses, and clinical outcomes. The study protocol does not mandate therapeutic interventions, which reflect standard clinical care, particularly antithrombotic strategies in patients suspected of VB-TIA.

The primary objectives of the study are to describe the clinical characteristics of VB-TNAs, assess the accuracy of the initial diagnostic classification over time, evaluate therapeutic outcomes, and identify prognostic factors associated with adverse events.

Keywords
vertigo and dizziness, Vertebrobasilar Transient Neurological Attack, TIA, Vestibular Symptom, Diagnostic Accuracy, Prognostic Factors, Emergency Department
Medical subject headings
Vertigo, Dizziness, Ischemic Attack, Transient, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07421973
Study groupRoleWhat they receive
VB-TIAPatients who experience TNAs due to a probable vascular cause and who meet one of the following criteria: (a) increased risk for vascular events, for example, ABCD2 score of 4 or greater or atrial fibrillation; (b) significant (>50%) narrowing of an artery in the vertebrobasilar (VB) system; (c) significant arterial hypoplasia or dolichoectasia; (d) an arterial malformation that favors ischemic events; and (e) isolated spontaneous episodic vertigo/dizziness in older adults with no other possible causes.
Migraine-like DisorderAplied in patients with no cardiovascular risk profile, and TNAs associated to one of the following: (a) evidence of migraine in previous history, or during the follow-up; (b) current headache that fulfils migraine criteria; (c) current or previous symptoms of motion sickness.
MiscellaneousComprise different diagnoses such as hypertensive crisis, functional attacks, atipical BPPV, and rare central disorders such as multiple sclerosis, tumors, or encephalitis.
UnclassifiedPatients who do not fullfil any of the previous, and have symptom constellations that are not characteristic of any distinct etiology

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic accuracy of the baseline clinical diagnosis of vertebrobasilar transient neurological attacks (VB-TNA)

    The proportion of patients for whom the initial clinical diagnosis of vertebrobasilar transient neurological attacks is confirmed or revised during follow-up based on clinical reassessment, neuroimaging, and a multidisciplinary evaluation.

    Measured: Up to 12 months.

Secondary outcomes (4)
  1. Number of participants with ischemic stroke or death during 12-month follow-up.

    The number of enrolled participants who experienced an ischemic stroke (clinically diagnosed and/or confirmed by neuroimaging) or died from any cause during the 12 months following the index event.

    Measured: Up to 12 months

  2. Number of participants with recurrence of transient neurological or vestibular symptoms during 12-month follow-up.

    The number of participants who reported new episodes of transient focal neurological or vestibular symptoms during the 12-month follow-up period after the index event.

    Measured: Up to 12 months.

  3. Number of participants with change in diagnostic classification between baseline and 12 months.

    The number of participants whose final diagnosis at 12 months differs from their initial classification (e.g., vertebrobasilar transient neurological attack, vestibular migraine, other causes, or unclassified).

    Measured: Up to 12 months.

  4. Number of participants with death, ischemic stroke, or recurrent vertebrobasilar transient neurological attack during 12-month follow-up among participants with final diagnosis of VB-TIA receiving prescribed treatment.

    The number of participants in the VB-TIA subgroup who experienced any of the following during follow-up after initiation of the prescribed treatment following the index event:

    1. death from any cause,
    2. stroke (clinically diagnosed and/or confirmed by neuroimaging), or
    3. recurrent TNA event (a new episode meeting the study's predefined VB-TNA criteria).

    Measured: Up to 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion30 May 2028 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07421973
Sponsor's protocol ID
UTRAVERA-HCFMUSP
Acronym
UTRAVERA
Status last verified
Feb 2026
First submitted
12 Feb 2026
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the results reported in publications, including demographic, clinical, imaging-derived categorical variables, and outcome measures.

Publications

  • Kim JS, Newman-Toker DE, Kerber KA, Jahn K, Bertholon P, Waterston J, Lee H, Bisdorff A, Strupp M. Vascular vertigo and dizziness: Diagnostic criteria. J Vestib Res. 2022;32(3):205-222. doi: 10.3233/VES-210169.

    PubMed 35367974
  • Filippopulos FM, Strobl R, Belanovic B, Dunker K, Grill E, Brandt T, Zwergal A, Huppert D. Validation of a comprehensive diagnostic algorithm for patients with acute vertigo and dizziness. Eur J Neurol. 2022 Oct;29(10):3092-3101. doi: 10.1111/ene.15448. Epub 2022 Jun 29.

    PubMed 35708513
  • Edlow JA, Carpenter C, Akhter M, Khoujah D, Marcolini E, Meurer WJ, Morrill D, Naples JG, Ohle R, Omron R, Sharif S, Siket M, Upadhye S, E Silva LOJ, Sundberg E, Tartt K, Vanni S, Newman-Toker DE, Bellolio F. Guidelines for reasonable and appropriate care in the emergency department 3 (GRACE-3): Acute dizziness and vertigo in the emergency department. Acad Emerg Med. 2023 May;30(5):442-486. doi: 10.1111/acem.14728.

    PubMed 37166022
  • Tuna MA, Rothwell PM; Oxford Vascular Study. Diagnosis of non-consensus transient ischaemic attacks with focal, negative, and non-progressive symptoms: population-based validation by investigation and prognosis. Lancet. 2021 Mar 6;397(10277):902-912. doi: 10.1016/S0140-6736(20)31961-9.

    PubMed 33676629
  • Neto ACL, Kim JS, Bernardo WM, Bittar RSM. Vertigo and dizziness due to vertebrobasilar TIA: a prospective study. Front Stroke. 2024 Oct 2;3:1429068. doi: 10.3389/fstro.2024.1429068. eCollection 2024.

    PubMed 41542262
  • Cortese E, Rochelle P, Patel F, Koohi N, Kaski D. Integrated diagnostic algorithm for acute vertigo combining TiTrATE, STANDING, and HINTS: a validation study in the emergency department. Sci Rep. 2025 Jul 14;15(1):25403. doi: 10.1038/s41598-025-11007-9.

    PubMed 40659780
  • Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.

    PubMed 34024117

Questions about this trial

What is this clinical trial studying?

An observational study of Vertigo and Dizziness, run by University of Sao Paulo General Hospital at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ARLINDO C NETO, PhD (+5515996928584, aclimanetoent@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic accuracy of the baseline clinical diagnosis of vertebrobasilar transient neurological attacks (VB-TNA) (time frame: Up to 12 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07421973, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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