<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/NCT02241252</url>
  </required_header>
  <id_info>
    <org_study_id>OU_IRB_3237</org_study_id>
    <nct_id>NCT02241252</nct_id>
  </id_info>
  <brief_title>Using an iPhone ECG to Monitor the QT Interval on Dofetilide and Sotalol Patients</brief_title>
  <official_title>Clinical Validation of an iPhone ECG System, QT Substudy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oklahoma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will validate the recording accuracy of a specific electrical interval of the&#xD;
      heart, the QT interval, between an iPhone rhythm strip recording and a traditional 12-lead&#xD;
      electrocardiogram (ECG). These measurements will occur in hospitalized patients that are&#xD;
      starting either sotalol or dofetilide, since both of these medications can prolong the QT&#xD;
      interval.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients that were already selected to begin either dofetilide or sotalol in the hospital,&#xD;
      will be included in the study. Patients will receive an ECG before and 2 hours after each&#xD;
      dose of the medication, which is done to monitor the QT interval. In addition, patients that&#xD;
      consent to participate in the study will have an iPhone ECG recording taken in lead positions&#xD;
      that correspond to leads I,II, and III.&#xD;
&#xD;
      These recordings will be compared and analyzed to assess the accuracy of the QT interval&#xD;
      recordings between the two methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>QT interval measurement (in milliseconds)</measure>
    <time_frame>Participants will be followed for duration of hospital stay during which dofetilide or sotalol are being started, an expected average of 3 days</time_frame>
    <description>The QT interval (measured from the start of the QRS to the end of the T wave) will be measured on the 12-lead ECG and on the iPhone rhythm strip recording. Both measurements will be recorded in milliseconds and will be statistically analyzed for bias and agreement.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Cardiac Arrhythmia</condition>
  <condition>Qt Interval, Variation in</condition>
  <arm_group>
    <arm_group_label>iPhone ECG QT recording</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>iPhone ECG</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iPhone ECG</intervention_name>
    <description>Please see detailed description for additional information.</description>
    <arm_group_label>iPhone ECG QT recording</arm_group_label>
    <other_name>AliveCor iPhone ECG</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  initiation of sotalol or dofetilide&#xD;
&#xD;
          -  inpatient at University hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul J Garabelli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oklahoma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dwight W Reynolds, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oklahoma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>May 28, 2015</last_update_submitted>
  <last_update_submitted_qc>May 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ECG</keyword>
  <keyword>QT interval</keyword>
  <keyword>Sotalol</keyword>
  <keyword>Dofetilide</keyword>
  <keyword>iPhone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <!-- 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/NCT02241252
org study id: OU_IRB_3237
nct id: NCT02241252
lead sponsor: 
has dmc: Yes
This study will validate the recording accuracy of a specific electrical interval of the
      heart, the QT interval, between an iPhone rhythm strip recording and a traditional 12-lead
      electrocardiogram (ECG). These measurements will occur in hospitalized patients that are
      starting either sotalol or dofetilide, since both of these medications can prolong the QT
      interval.
Patients that were already selected to begin either dofetilide or sotalol in the hospital,
      will be included in the study. Patients will receive an ECG before and 2 hours after each
      dose of the medication, which is done to monitor the QT interval. In addition, patients that
      consent to participate in the study will have an iPhone ECG recording taken in lead positions
      that correspond to leads I,II, and III.

      These recordings will be compared and analyzed to assess the accuracy of the QT interval
      recordings between the two methods.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: QT interval measurement (in milliseconds)
time frame: Participants will be followed for duration of hospital stay during which dofetilide or sotalol are being started, an expected average of 3 days
description: The QT interval (measured from the start of the QRS to the end of the T wave) will be measured on the 12-lead ECG and on the iPhone rhythm strip recording. Both measurements will be recorded in milliseconds and will be statistically analyzed for bias and agreement.
arm group label: iPhone ECG QT recording
arm group type: Other
description: iPhone ECG
intervention type: Device
intervention name: iPhone ECG
description: Please see detailed description for additional information.
arm group label: iPhone ECG QT recording
other name: AliveCor iPhone ECG
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Paul J Garabelli, MD
role: Principal Investigator
affiliation: University of Oklahoma
last name: Dwight W Reynolds, MD
role: Principal Investigator
affiliation: University of Oklahoma
facility: 
country: United States
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac