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

Dizziness Clinical Trial

Official title:

Validating a Clinical Decision Support Tool for Stratifying Stroke Risk in Patients Presenting With Dizziness to the Emergency Department

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06010550
• Other study ID #: IRB2023009
• Status: Not yet recruiting
• Start date: October 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Chiayi Christian Hospital
• Contact: Sheng-Feng Sung, MD, PhD
• Phone: 886-5-2765041
• Email: sfsung[@]cych.org.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: December 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dizziness
• Vertigo

Intervention

Radiation:
• Magnetic resonance imaging
Brain magnetic resonance imaging

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chiayi Christian Hospital	National Science and Technology Council

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with stroke	Number of participants with ischemic or hemorrhagic stroke confirmed by brain magnetic resonance imaging	Between 24 hours and 14 days after the emergency department visit