DizzinessNCT06010550
Validating a Clinical Decision Support Tool for Stratifying Stroke Risk for Dizziness/Vertigo
An observational study of Dizziness and Vertigo, run by Chiayi Christian Hospital.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- What is being tested?
- Magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who visit the emergency department.
Who may be able to join
- 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
Who cannot join
- 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
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- Concomitant head or neck trauma
- Severe degenerative cervical spondylosis
- Having contraindications to magnetic resonance imaging examination
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Being tested
- Magnetic resonance imaging
- Keywords
- Dizzy, Vertigo, Stroke, Machine learning
- Medical subject headings
- Dizziness, Vertigo, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingRadiation
Brain magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| Dizziness/vertigo | Patients aged 20 or above, presenting to the emergency department with dizziness or vertigo. Receives: Radiation: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with stroke
Number of participants with ischemic or hemorrhagic stroke confirmed by brain magnetic resonance imaging
Measured: Between 24 hours and 14 days after the emergency department visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Oct 2023 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DizzinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiayi Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council
- Responsible party
- Sponsor
- Investigators
- Sheng-Feng Sung, MD, PhD, Principal investigator, Ditmanson Medical Foundation Chia-Yi Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010550
- Sponsor's protocol ID
- IRB2023009
- Status last verified
- Aug 2023
- First submitted
- 20 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating a Clinical Decision Support Tool for Stratifying Stroke Risk in Patients Presenting With Dizziness to the Emergency Department
- ClinicalTrials.gov ID
- NCT06010550
- Acronym / sponsor ID
- IRB2023009
- Keywords
- Dizzy, Vertigo, Stroke, Machine learning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Chiayi Christian HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dizziness/vertigo | – | Radiation: Magnetic resonance imagingPatients aged 20 or above, presenting to the emergency department with dizziness or vertigo. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who visit the emergency department.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imagingBrain magnetic resonance imaging | Radiation | Dizziness/vertigo |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheng-Feng Sung, MD, PhD principal investigator
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Dizziness and Vertigo, run by Chiayi Christian Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheng-Feng Sung, MD, PhD (886-5-2765041 ext. 7284, sfsung@cych.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with stroke (time frame: Between 24 hours and 14 days after the emergency department visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.