Validating a Clinical Decision Support Tool for Stratifying Stroke Risk for Dizziness/Vertigo

Not yet recruiting

• Conditions: Dizziness; Vertigo
• Interventions: Radiation: Magnetic resonance imaging

• Registration Number: NCT06010550
• Lead Sponsor: Chiayi Christian Hospital

Brief Summary

This study aims to validate a machine learning model that stratifies the risk of stroke in patients who present to the emergency department with dizziness or vertigo.

Detailed Description

This is a cross-sectional, hospital-based study, with no randomization procedure. Over a 21-month period, approximately 600 subjects will be enrolled. The study will assess the risk of stroke in each patient using a machine-learning model. To detect ischemic or hemorrhagic stroke, each patient will undergo a non-contrast brain magnetic resonance imaging study. The predictive performance of the machine-learning model will be evaluated in terms of accuracy, precision, recall, F1 score, and area under the receiver operating characteristics curve.

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-20
• Study First Submitted QC: 2023-08-20
• Study First Posted: 2023-08-24
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-29
• Study Start: 2023-10-01
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Presenting to the emergency department with dizziness or vertigo
• Aged ≥ 20
• Dizziness or vertigo lasting for at least 1 hour and < 7 days
• Persistent dizziness or vertigo at the time of the examination at the emergency department

Exclusion Criteria

• Having 5 or more prior episodes similar in quality, intensity, and duration to the current symptoms, with at least one episode more than a year prior and one within the past year
• Having frank stroke-like symptoms or signs, such as hemiparesis, facial asymmetry, dysarthria, dysphasia, ataxia, gaze palsy
• Consciousness disturbance, Glasgow coma scale < 13
• Severe dementia
• Recent stroke within 3 months
• Dizziness or vertigo thought to be the result of head injury, hypotension, medication/drug intoxication, hypoglycemia, electrolyte imbalance, anemia, hepatic encephalopathy, hydrocephalus, etc
• Concomitant head or neck trauma
• Severe degenerative cervical spondylosis
• Having contraindications to magnetic resonance imaging examination

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dizziness/vertigo	Magnetic resonance imaging	Patients aged 20 or above, presenting to the emergency department with dizziness or vertigo.

Primary Outcome Measures

Name	Time	Method
Number of participants with stroke	Between 24 hours and 14 days after the emergency department visit	Number of participants with ischemic or hemorrhagic stroke confirmed by brain magnetic resonance imaging