Validation of TriAGE+ for Predicting Stroke Risk in ED Patients Presenting With Dizziness

NCT06641050 | Completed

• 1 other identifier: 09.2024.240
• Study Type: observational
• Target: 818
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic

Keywords

Triage+; Cerebrovascular Accident; Dizzyness; Neurologic Deficits

Outcome Measures

Primary Outcomes (1)

• Stroke

  Stroke will be defined as a new diagnosis of acute ischemic stroke or intracranial hemorrhage occurring within 30 days after the index emergency department visit for dizziness. The diagnosis will be based on clinical evaluation supported by neuroimaging findings, including cranial computed tomography and/or magnetic resonance imaging, and/or documentation by a neurologist or treating physician in the medical record.

  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

Adults aged 18 years or older presenting to the emergency department with dizziness will be enrolled and followed for 30 days to assess the occurrence of cerebrovascular events, including stroke. No treatment or diagnostic intervention will be assigned by the study protocol. Clinical evaluation and management will be performed according to routine emergency department practice.

Other: TRIAGE+ score assessment

Interventions

TRIAGE+ score assessment OTHER

The TRIAGE+ score will be recorded or calculated in adults presenting to the emergency department with dizziness. The score will be evaluated for its association with cerebrovascular events occurring within 30 days. No study-directed treatment, imaging strategy, medication, or management decision will be assigned by the study protocol.

Patients with dizziness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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.

Sponsors & Collaborators

• Marmara University Pendik Training and Research Hospital: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Dizziness; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Sensation Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: March 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)