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NCT Number: NCT07421973

Prospective Registry of Vertigo Due to Vertebrobasilar Transient Attacks.

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: Up to 12 months.

    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.

Secondary outcomes

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

    Time frame: Up to 12 months

    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.

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

    Time frame: Up to 12 months.

    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.

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

    Time frame: Up to 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).

  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.

    Time frame: Up to 12 months.

    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:

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

Study contacts

Contact information is provided by the study sponsor or research team.

ARLINDO C NETO, PhD

CONTACT

[email protected]

+5515996928584

Ji-Soo Kim, PhD

CONTACT

[email protected]

+82 31 787 7463

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • LMU Klinikum
  • Seoul National University Bundang Hospital
  • University College, London
  • University of Zurich

Registry information

Official study 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.

Acronym: UTRAVERA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 19, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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