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

NCT ID: NCT06010550

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-12-31

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.

Conditions

Dizziness; Vertigo

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Dizziness/vertigo

Patients aged 20 or above, presenting to the emergency department with dizziness or vertigo.

Magnetic resonance imaging

Intervention Type: RADIATION

Brain magnetic resonance imaging

Interventions

Magnetic resonance imaging

Brain magnetic resonance imaging

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council

FED

Sponsor Role: collaborator

Chiayi Christian Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sheng-Feng Sung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ditmanson Medical Foundation Chia-Yi Christian Hospital

Central Contacts

Sheng-Feng Sung, MD, PhD

Role: CONTACT

sfsung@cych.org.tw

886-5-2765041 ext. 7284

Other Identifiers

IRB2023009

Identifier Type: -

Identifier Source: org_study_id