NCT06641050

Brief Summary

Ischemic cerebrovascular diseases originating from the brain's posterior circulation account for 20-25% of cases. Among patients diagnosed with cerebellar infarction, 10% present with isolated dizziness as their sole symptom. Notably, posterior circulation strokes and cerebellar infarcts are misdiagnosed 2 to 4 times more frequently than anterior circulation strokes. In 2017, Kuroda et al. developed the TriAGE+ score to assess stroke risk in patients presenting with dizziness. This study aims to externally validate the TriAGE+ score, focusing on its safety, applicability, and reliability in predicting cerebrovascular disease in the emergency department.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
841

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 7, 2025

Status Verified

October 1, 2025

Enrollment Period

1.5 years

First QC Date

October 11, 2024

Last Update Submit

October 1, 2025

Conditions

Keywords

Triage+Cerebrovascular AccidentDizzynessNeurologic Deficits

Outcome Measures

Primary Outcomes (1)

  • Stroke

    The outcome for this study was the occurrence of stroke, defined as a new sudden neurological deficit of vascular origin.

    30 days (patient will be followed up 30 days based on their initial visit with dizziness. During the 30-day period, any subsequent visits to relevant specialities or the emergency department will be reviewed to assess for a stroke diagnosis.)

Study Arms (1)

Patients with dizziness

Individuals aged 18 years and over who present to the emergency department with dizziness will be assessed using the TriAGE+ score.

Diagnostic Test: Triage+ Score

Interventions

Triage+ ScoreDIAGNOSTIC_TEST

The TriAGE+ score is used to evaluate the risk of cerebrovascular disease in patients presenting with dizziness. The score assists in determining the necessity of advanced diagnostic evaluation for stroke, potentially improving diagnostic accuracy and patient outcomes.

Patients with dizziness

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include adult (\>18 years old) patients presenting to the emergency department with dizziness. These patients must provide informed consent, or consent must be obtained from their legal guardians if the patients are unable to do so. This population will serve as the basis for externally validating the TriAGE+ score, developed in Japan, in a Turkish emergency department setting.

You may qualify if:

  • Patients with dizziness who presented to the emergency department
  • Patients who provide informed consent, or legal guardians providing consent for patients unable to do so.

You may not qualify if:

  • Patients whose primary symptom is syncope or presyncope, or who present with dizziness due to hemodynamic compromise from gastrointestinal bleeding or other major events.
  • Patients under the influence of alcohol or substances.
  • Pregnant patients.
  • Patients previously included in the study.
  • Patients who refuse medical treatment or withdraw consent.
  • Patients with incomplete data necessary for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeStrokeDizzinessNeurologic Manifestations

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSensation DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 11, 2024

First Posted

October 15, 2024

Study Start

June 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

October 7, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations