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

C

Chiayi Christian Hospital

Status

Not yet enrolling

Conditions

Vertigo
Dizziness

Treatments

Radiation: Magnetic resonance imaging

Study type

Observational

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT06010550
IRB2023009

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

600 participants in 1 patient group

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

Trial contacts and locations

0

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Central trial contact

Sheng-Feng Sung, MD, PhD

Data sourced from clinicaltrials.gov

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