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

NCT06010550 | Unknown

• 1 other identifier: IRB2023009
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dizziness; Vertigo

Keywords

Dizzy; Vertigo; Stroke; Machine learning

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Dizziness/vertigo

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

Radiation: Magnetic resonance imaging

Interventions

Magnetic resonance imaging RADIATION

Brain magnetic resonance imaging

Dizziness/vertigo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who visit the emergency department.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiayi Christian Hospital: lead
• National Science and Technology Council: collaborator

MeSH Terms

Conditions

Dizziness; Vertigo; Stroke

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Sheng-Feng Sung, MD, PhD

  Ditmanson Medical Foundation Chia-Yi Christian Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng-Feng Sung, MD, PhD

CONTACT

886-5-2765041; sfsung@cych.org.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2023
• First Posted: August 24, 2023
• Study Start: October 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 29, 2023

Record last verified: 2023-08