<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/NCT03273803</url>
  </required_header>
  <id_info>
    <org_study_id>B-1609-361-303</org_study_id>
    <nct_id>NCT03273803</nct_id>
  </id_info>
  <brief_title>Cardiac Auscultation Using Smartphones</brief_title>
  <official_title>Cardiac Auscultation Using Smartphones: a Proof-of-concept Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Korea Advanced Institute of Science and Technology</agency>
      <agency_class>Other</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>
      The investigators performed a proof-of-concept study enrolling subjects with normal and&#xD;
      pathologic heart sounds. Heart sound was recorded by auscultation on the skin of the chest&#xD;
      wall using three smartphones: Samsung Galaxy S5 and Galaxy S6, and LG G3 . Recorded heart&#xD;
      sounds were processed and classified by a diagnostic algorithm using convolutional neural&#xD;
      networks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Heart sound recording was done by researchers who were familiar with the use of the app and&#xD;
      understand the principles of cardiac auscultation.&#xD;
&#xD;
      Reference heart sounds were recorded using an electronic stethoscope (3M™ Littmann®&#xD;
      Electronic Stethoscope Model 3200). Study devices included Samsung Galaxy S5 (model SM-G900),&#xD;
      Galaxy S6 (SM-G920), and LG G3 (LG-F400).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 24, 2016</start_date>
  <completion_date type="Actual">June 8, 2017</completion_date>
  <primary_completion_date type="Actual">October 31, 2016</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of &quot;CPstethoscope&quot; in interpretation of heart sounds</measure>
    <time_frame>0</time_frame>
    <description>specificity, sensitivity, negative predictive value, positive predictive value</description>
  </primary_outcome>
  <enrollment type="Actual">46</enrollment>
  <condition>Cardiovascular Physiological Phenomena</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Heart sound recording using smartphone application</intervention_name>
    <description>Heart sound recording and analysis using android smartphones (Samsung Galaxy S5, Galaxy S6, and LG G3)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Men and women were evenly enrolled, and the median age was 65.5 years.&#xD;
&#xD;
        Twenty subjects (43.5%) had systolic murmur, 20 (43.5%) normal heart sound, 5 (10.9%)&#xD;
        diastolic murmur, and 1 (2.2%) S4.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects who gave informed consent&#xD;
&#xD;
          -  subjects who are 18 years old or older and had performed ECG and echocardiography&#xD;
             during the previous 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects with impairment of cognition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Jung-Won Suh, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggi-do</state>
        <zip>463707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 3, 2017</study_first_submitted>
  <study_first_submitted_qc>September 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jung-Won Suh</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Heart sounds, smartphone, application</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03273803
org study id: B-1609-361-303
nct id: NCT03273803
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The investigators performed a proof-of-concept study enrolling subjects with normal and
      pathologic heart sounds. Heart sound was recorded by auscultation on the skin of the chest
      wall using three smartphones: Samsung Galaxy S5 and Galaxy S6, and LG G3 . Recorded heart
      sounds were processed and classified by a diagnostic algorithm using convolutional neural
      networks.
Heart sound recording was done by researchers who were familiar with the use of the app and
      understand the principles of cardiac auscultation.

      Reference heart sounds were recorded using an electronic stethoscope (3M™ Littmann®
      Electronic Stethoscope Model 3200). Study devices included Samsung Galaxy S5 (model SM-G900),
      Galaxy S6 (SM-G920), and LG G3 (LG-F400).
observational model: Case-Only
time perspective: Cross-Sectional
measure: Accuracy of "CPstethoscope" in interpretation of heart sounds
time frame: 0
description: specificity, sensitivity, negative predictive value, positive predictive value
intervention type: Diagnostic Test
intervention name: Heart sound recording using smartphone application
description: Heart sound recording and analysis using android smartphones (Samsung Galaxy S5, Galaxy S6, and LG G3)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Jung-Won Suh, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jung-Won Suh
investigator title: MD, PhD
sharing ipd: Undecided