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/NCT06036342</url>
    </required_header>
    <id_info>
      <org_study_id>AF-CARE</org_study_id>
      <nct_id>NCT06036342</nct_id>
    </id_info>
    <brief_title>Atrial Fibrillation Screening With MobiCARE in Subjects With Health Care Examination</brief_title>
    <official_title>Atrial Fibrillation Screening With MobiCARE in Subjects With Health Care Examination</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seoul National University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Daewoong Pharmaceutical Co. LTD.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Seoul National University Hospital</source>
    <oversight_info>
      <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 aimed to detect and diagnose atrial fibrillation early by conducting a screening&#xD;
        test for atrial fibrillation using a continuous electrocardiography monitoring device for&#xD;
        those who have undergone a health screening examination.&#xD;
  &#xD;
        Early detection through atrial fibrillation screening tests in high-risk patients with stroke&#xD;
        is intended to prevent stroke by starting stroke prevention treatment early. It is intended&#xD;
        to detect asymptomatic atrial fibrillation patients early through examination and ultimately&#xD;
        improve the quality of life.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 25, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Atrial fibrillation detection rate</measure>
      <time_frame>1 year</time_frame>
      <description>Atrial fibrillation detection rate at 1-year follow-up time</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The detection rate of atrial fibrillation</measure>
      <time_frame>up to 7 days</time_frame>
      <description>The detection rate of atrial fibrillation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The burden of atrial fibrillation.</measure>
      <time_frame>up to 7 days</time_frame>
      <description>The burden of atrial fibrillation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The detection rate of other arrhythmias</measure>
      <time_frame>up to 7 days</time_frame>
      <description>The detection rate of other arrhythmias in addition to atrial fibrillation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of initiation of antiarrhythmic and anticoagulant therapy, and the rate of receiving treatment related to rhythm control</measure>
      <time_frame>1 year</time_frame>
      <description>The rate of initiation of antiarrhythmic and anticoagulant therapy, and the rate of receiving treatment related to rhythm control at 1-year follow-up time</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical outcome during 1-year follow-up.</measure>
      <time_frame>1 year</time_frame>
      <description>stroke, transient ischemic attack, systemic embolism, admission for heart failure, admission for atrial fibrillation manage/control, cardiac arrest, cardiovascular death, and all-cause death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the convenience of wearing and using the Mobicare device</measure>
      <time_frame>up to 1 month</time_frame>
      <description>Questionnaire about convenience of wearing and using the Mobicare device&#xD;
  Did you feel uncomfortable going about your daily routine, and mainly when?&#xD;
  If you felt uncomfortable, what were your main concerns?&#xD;
  If your skin itches or breaks out in a rash during use, how long has it been since you've been wearing it?&#xD;
  How much discomfort did you experience due to foreign body sensation, skin problems, etc.?&#xD;
  Has your device ever been dropped while in use? If so, when did it happen?&#xD;
  Were there any challenges in reattaching the device, and if so, what were they?&#xD;
  How often have you taken your device off and put it back on?&#xD;
  How long do you think you can run the test without too much inconvenience?</description>
    </secondary_outcome>
    <enrollment type="Anticipated">3000</enrollment>
    <condition>Atrial Fibrillation</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>MobiCARE test</intervention_name>
      <description>7-days continuous electrocardiography monitoring using MobiCARE device</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Those who have undergone a health screening examination.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subjects aged 65 years or older who have at least one stroke risk factor*&#xD;
  &#xD;
            2. Subjects aged 19 years to &lt;65 years who have two or more stroke risk factors.&#xD;
  &#xD;
            3. Subjects aged 75 years or older&#xD;
  &#xD;
                 -  Stroke risk factors: heart failure, hypertension, diabetes, vascular disease,&#xD;
                    women, stroke/systemic embolism/transient ischemic attack (although&#xD;
                    stroke/systemic embolism/transient ischemic attack among stroke risk factors is&#xD;
                    considered to have two risk factors)&#xD;
  &#xD;
                 -  Heart failure: a history of heart failure diagnosis or a history of current heart&#xD;
                    failure treatment.&#xD;
  &#xD;
                 -  Hypertension, Diabetes: Diagnostic History&#xD;
  &#xD;
                 -  Vascular diseases: Significant coronal atherosclerosis (when 70% or more of the&#xD;
                    computed tomography or coronary angiography is present or coronary intervention&#xD;
                    is performed), 50% or more of the carotid artery disease, peripheral vascular&#xD;
                    disease, history of myocardial infarction, and aortic plaques&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects diagnosed with atrial fibrillation in the past&#xD;
  &#xD;
            2. Subjects aged under 19 years and other vulnerable research subjects&#xD;
  &#xD;
            3. Subjects who have patch-type adhesive allergies/atopy dermatitis/ urticaria/skin&#xD;
               rash/hives that are difficult to apply patches continuously&#xD;
  &#xD;
            4. Subjects who have a structural abnormality in the thorax and is difficult to attach&#xD;
               the device.&#xD;
  &#xD;
            5. Subjects who have cardiac implantable electronic device (pacemaker, implantable&#xD;
               cardioverter-defibrillator, implantable loop recorder, or cardiac resynchronized&#xD;
               therapy-pacemaker or defibrillator)&#xD;
  &#xD;
            6. Subjects requiring immediate ECG analysis or ECG monitoring through hospitalization&#xD;
               due to arrhythmia that can be life-threatening&#xD;
  &#xD;
            7. Subjects who are deemed inappropriate to participate in the research as judged by the&#xD;
               researcher for other reasons.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Eue-Keun Choi, M.D. Ph.D.</last_name>
      <phone>82-2-2072-0688</phone>
      <email>choiek417@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Seoul National University Hospital</name>
        <address>
          <city>Seoul</city>
          <state>Jongno-gu</state>
          <zip>03080</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eue-Keun Choi</last_name>
        <phone>82-2-2072-0688</phone>
        <email>choiek417@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>March 20, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
      <investigator_full_name>Eue-Keun Choi</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atrial Fibrillation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06036342
  org study id: AF-CARE
  nct id: NCT06036342
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed to detect and diagnose atrial fibrillation early by conducting a screening
        test for atrial fibrillation using a continuous electrocardiography monitoring device for
        those who have undergone a health screening examination.
  
        Early detection through atrial fibrillation screening tests in high-risk patients with stroke
        is intended to prevent stroke by starting stroke prevention treatment early. It is intended
        to detect asymptomatic atrial fibrillation patients early through examination and ultimately
        improve the quality of life.
  observational model: Case-Only
  time perspective: Prospective
  measure: Atrial fibrillation detection rate
  time frame: 1 year
  description: Atrial fibrillation detection rate at 1-year follow-up time
  measure: The detection rate of atrial fibrillation
  time frame: up to 7 days
  description: The detection rate of atrial fibrillation
  measure: The burden of atrial fibrillation.
  time frame: up to 7 days
  description: The burden of atrial fibrillation.
  measure: The detection rate of other arrhythmias
  time frame: up to 7 days
  description: The detection rate of other arrhythmias in addition to atrial fibrillation
  measure: The rate of initiation of antiarrhythmic and anticoagulant therapy, and the rate of receiving treatment related to rhythm control
  time frame: 1 year
  description: The rate of initiation of antiarrhythmic and anticoagulant therapy, and the rate of receiving treatment related to rhythm control at 1-year follow-up time
  measure: Clinical outcome during 1-year follow-up.
  time frame: 1 year
  description: stroke, transient ischemic attack, systemic embolism, admission for heart failure, admission for atrial fibrillation manage/control, cardiac arrest, cardiovascular death, and all-cause death
  measure: Evaluation of the convenience of wearing and using the Mobicare device
  time frame: up to 1 month
  description: Questionnaire about convenience of wearing and using the Mobicare device
  Did you feel uncomfortable going about your daily routine, and mainly when?
  If you felt uncomfortable, what were your main concerns?
  If your skin itches or breaks out in a rash during use, how long has it been since you've been wearing it?
  How much discomfort did you experience due to foreign body sensation, skin problems, etc.?
  Has your device ever been dropped while in use? If so, when did it happen?
  Were there any challenges in reattaching the device, and if so, what were they?
  How often have you taken your device off and put it back on?
  How long do you think you can run the test without too much inconvenience?
  intervention type: Diagnostic Test
  intervention name: MobiCARE test
  description: 7-days continuous electrocardiography monitoring using MobiCARE device
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Eue-Keun Choi, M.D. Ph.D.
  phone: 82-2-2072-0688
  email: choiek417@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Seoul National University Hospital
  investigator full name: Eue-Keun Choi
  investigator title: Professor
  mesh term: Atrial Fibrillation
  sharing ipd: No