Prospective Registry of Vertigo Due to Vertebrobasilar Transient Attacks.

NCT07421973 | Not Yet Recruiting

• 1 other identifier: UTRAVERA-HCFMUSP
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Vertigo; Dizziness; TIA (Transient Ischemic Attack); Transient Neurologic Symptoms

Keywords

vertigo and dizziness; Vertebrobasilar Transient Neurological Attack; TIA; Vestibular Symptom; Diagnostic Accuracy; Prognostic Factors; Emergency Department

Outcome Measures

Primary Outcomes (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.

  Up to 12 months.

Secondary Outcomes (4)

• Number of participants with ischemic stroke or death during 12-month follow-up.

  Up to 12 months

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

  Up to 12 months.

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

  Up to 12 months.

• 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.

  Up to 12 months.

Study Arms (4)

VB-TIA

Patients 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 Disorder

Aplied 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.

Miscellaneous

Comprise different diagnoses such as hypertensive crisis, functional attacks, atipical BPPV, and rare central disorders such as multiple sclerosis, tumors, or encephalitis.

Unclassified

Patients who do not fullfil any of the previous, and have symptom constellations that are not characteristic of any distinct etiology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Seoul National University Bundang Hospital: collaborator
• University of Zurich: collaborator
• University College, London: collaborator
• LMU Klinikum: collaborator

Study Sites (1)

Hospital das Clínicas - University of São Paulo

São Paulo, São Paulo, 05403900, Brazil

Location

Related Publications (7)

• Kim, J. S., Newman-Toker, D. E., Kerber, K. A., Jahn, K., Bertholon, P., Waterston, J., ... & Strupp, M. (2022). Vascular vertigo and dizziness: Diagnostic criteria: consensus document of the committee for the classification of vestibular disorders of the Bárány society. Journal of Vestibular Research, 32(3), 205-222.

  BACKGROUND

• Filippopulos, F. M., Strobl, R., Belanovic, B., Dunker, K., Grill, E., Brandt, T., et al. (2022). Validation of a comprehensive diagnostic algorithm for patients with acute vertigo and dizziness. Eur. J. Neurol. 29, 3092-3101. doi: 10.1111/ ene.15448

  BACKGROUND

• Edlow, J. A., Carpenter, C., Akhter, M., Khoujah, D., Marcolini, E., Meurer, W.J., et al. (2023). Guidelines for reasonable and appropriate care in the emergency department 3 (GRACE-3): acute dizziness and vertigo in the emergency department. Acad. Emer. Med. 30, 442-486. doi: 10.1111/acem.14728

  BACKGROUND

• Tuna, M. A., & Rothwell, P. M. (2021). Diagnosis of non-consensus transient ischaemic attacks with focal, negative, and non-progressive symptoms: population-based validation by investigation and prognosis. The Lancet, 397(10277), 902-912.

  BACKGROUND

• Neto, A. C. L., Kim, J. S., Bernardo, W. M., & Bittar, R. S. M. (2024). Vertigo and dizziness due to vertebrobasilar TIA: a prospective study. Frontiers in Stroke, 3, 1429068.

  BACKGROUND

• Cortese, E., Rochelle, P. L., Patel, F., Koohi, N., & Kaski, D. (2025). Integrated diagnostic algorithm for acute vertigo combining TiTrATE, STANDING, and HINTS: a validation study in the emergency department. Scientific Reports, 15(1), 25403.

  BACKGROUND

• Kleindorfer, D. O., Towfighi, A., Chaturvedi, S., Cockroft, K. M., Gutierrez, J., Lombardi-Hill, D., ... & Williams, L. S. (2021). 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, 52(7), e364-e467.Strupp M, Magnusson M. Acute unilateral vestibulopathy. Neurol Clin. 2015;33(3):669-685.

  BACKGROUND

MeSH Terms

Conditions

Vertigo; Dizziness; Ischemic Attack, Transient; Emergencies

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes

Study Officials

• Ji-Soo Kim, PhD

  Seoul National University Bundang Hospital

  STUDY CHAIR

Central Study Contacts

ARLINDO C NETO, PhD

CONTACT

+5515996928584; aclimanetoent@gmail.com

Ji-Soo Kim, PhD

CONTACT

+82 31 787 7463; jisookim@snu.ac.kr

Study Design

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

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Individual participant data (IPD) and supporting documents will be available beginning 6 months after publication of the primary study results and will remain available for a period of 5 years thereafter.
• Access Criteria: Access to de-identified individual participant data and supporting documents will be granted to qualified researchers who submit a methodologically sound proposal addressing research questions consistent with the objectives of the UTRAVERA study. Requests will be reviewed by the study steering committee. Data access will be provided following approval and execution of a data use agreement.

Locations

BR (1)