xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06010550</url>
    </required_header>
    <id_info>
      <org_study_id>IRB2023009</org_study_id>
      <nct_id>NCT06010550</nct_id>
    </id_info>
    <brief_title>Validating a Clinical Decision Support Tool for Stratifying Stroke Risk for Dizziness/Vertigo</brief_title>
    <official_title>Validating a Clinical Decision Support Tool for Stratifying Stroke Risk in Patients Presenting With Dizziness to the Emergency Department</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chiayi Christian Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Science and Technology Council</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>Chiayi Christian Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to validate a machine learning model that stratifies the risk of stroke in&#xD;
        patients who present to the emergency department with dizziness or vertigo.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a cross-sectional, hospital-based study, with no randomization procedure. Over a&#xD;
        21-month period, approximately 600 subjects will be enrolled. The study will assess the risk&#xD;
        of stroke in each patient using a machine-learning model. To detect ischemic or hemorrhagic&#xD;
        stroke, each patient will undergo a non-contrast brain magnetic resonance imaging study. The&#xD;
        predictive performance of the machine-learning model will be evaluated in terms of accuracy,&#xD;
        precision, recall, F1 score, and area under the receiver operating characteristics curve.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants with stroke</measure>
      <time_frame>Between 24 hours and 14 days after the emergency department visit</time_frame>
      <description>Number of participants with ischemic or hemorrhagic stroke confirmed by brain magnetic resonance imaging</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">600</enrollment>
    <condition>Dizziness</condition>
    <condition>Vertigo</condition>
    <arm_group>
      <arm_group_label>Dizziness/vertigo</arm_group_label>
      <description>Patients aged 20 or above, presenting to the emergency department with dizziness or vertigo.</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Magnetic resonance imaging</intervention_name>
      <description>Brain magnetic resonance imaging</description>
      <arm_group_label>Dizziness/vertigo</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects who visit the emergency department.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Presenting to the emergency department with dizziness or vertigo&#xD;
  &#xD;
            -  Aged ≥ 20&#xD;
  &#xD;
            -  Dizziness or vertigo lasting for at least 1 hour and &lt; 7 days&#xD;
  &#xD;
            -  Persistent dizziness or vertigo at the time of the examination at the emergency&#xD;
               department&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having 5 or more prior episodes similar in quality, intensity, and duration to the&#xD;
               current symptoms, with at least one episode more than a year prior and one within the&#xD;
               past year&#xD;
  &#xD;
            -  Having frank stroke-like symptoms or signs, such as hemiparesis, facial asymmetry,&#xD;
               dysarthria, dysphasia, ataxia, gaze palsy&#xD;
  &#xD;
            -  Consciousness disturbance, Glasgow coma scale &lt; 13&#xD;
  &#xD;
            -  Severe dementia&#xD;
  &#xD;
            -  Recent stroke within 3 months&#xD;
  &#xD;
            -  Dizziness or vertigo thought to be the result of head injury, hypotension,&#xD;
               medication/drug intoxication, hypoglycemia, electrolyte imbalance, anemia, hepatic&#xD;
               encephalopathy, hydrocephalus, etc&#xD;
  &#xD;
            -  Concomitant head or neck trauma&#xD;
  &#xD;
            -  Severe degenerative cervical spondylosis&#xD;
  &#xD;
            -  Having contraindications to magnetic resonance imaging examination&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sheng-Feng Sung, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ditmanson Medical Foundation Chia-Yi Christian Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sheng-Feng Sung, MD, PhD</last_name>
      <phone>886-5-2765041</phone>
      <phone_ext>7284</phone_ext>
      <email>sfsung@cych.org.tw</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Dizzy</keyword>
    <keyword>Vertigo</keyword>
    <keyword>Stroke</keyword>
    <keyword>Machine learning</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vertigo</mesh_term>
      <mesh_term>Dizziness</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06010550
  org study id: IRB2023009
  nct id: NCT06010550
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Number of participants with stroke
  time frame: Between 24 hours and 14 days after the emergency department visit
  description: Number of participants with ischemic or hemorrhagic stroke confirmed by brain magnetic resonance imaging
  arm group label: Dizziness/vertigo
  description: Patients aged 20 or above, presenting to the emergency department with dizziness or vertigo.
  intervention type: Radiation
  intervention name: Magnetic resonance imaging
  description: Brain magnetic resonance imaging
  arm group label: Dizziness/vertigo
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sheng-Feng Sung, MD, PhD
  role: Principal Investigator
  affiliation: Ditmanson Medical Foundation Chia-Yi Christian Hospital
  last name: Sheng-Feng Sung, MD, PhD
  phone: 886-5-2765041
  phone ext: 7284
  email: sfsung@cych.org.tw
  responsible party type: Sponsor
  mesh term: Vertigo
  mesh term: Dizziness
  sharing ipd: Undecided