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

August 25, 2023 updated by: Chiayi Christian Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sheng-Feng Sung, MD, PhD
  • Phone Number: 7284 886-5-2765041
  • Email: sfsung@cych.org.tw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects who visit the emergency department.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dizziness/vertigo
Patients aged 20 or above, presenting to the emergency department with dizziness or vertigo.
Radiation: Magnetic resonance imaging
Brain magnetic resonance imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with stroke
Time Frame: 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
Between 24 hours and 14 days after the emergency department visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiayi Christian Hospital

Collaborators

National Science and Technology Council

Investigators

  • Principal Investigator: Sheng-Feng Sung, MD, PhD, Ditmanson Medical Foundation Chia-Yi Christian Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 20, 2023

First Submitted That Met QC Criteria

August 20, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2023009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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