<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/NCT03037229</url>
  </required_header>
  <id_info>
    <org_study_id>16-004793</org_study_id>
    <nct_id>NCT03037229</nct_id>
  </id_info>
  <brief_title>Smartphone Twelve Lead Electrocardiogram Utility In ST-Elevation Myocardial Infarction</brief_title>
  <acronym>ST LEUIS</acronym>
  <official_title>Smartphone Twelve Lead Electrocardiogram Utility In ST-Elevation Myocardial Infarction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AliveCor</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Is the Smartphone ECG (electrocardiogram) an acceptable replacement for a standard ECG in the&#xD;
      identification of STEMI (ST Elevation Myocardial Infarction).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to determine if the Smartphone electrocardiogram (ECG)&#xD;
      is an acceptable replacement for a standard ECG in the identification of ST Elevation&#xD;
      Myocardial Infarction (STEMI).&#xD;
&#xD;
      Toward this objective, this study involves the following:&#xD;
&#xD;
      Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone &quot;12-lead equivalent&quot;&#xD;
      ECG on patients presenting with chest pain in which the STEMI protocol was activated.&#xD;
&#xD;
      Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone &quot;12-lead equivalent&quot;&#xD;
      ECG on patients presenting to the Emergency Department for evaluation of chest pain, not&#xD;
      necessarily presenting with STEMI.&#xD;
&#xD;
      Reading of ECGs (standard 12-lead and iPhone) by three independent cardiologists, who are&#xD;
      blinded to the initial clinical ECG readings, the type of ECG equipment used, and the&#xD;
      patient's clinical information.&#xD;
&#xD;
      Assess the operational feasibility of using the Smartphone to obtain &quot;12-lead equivalent&quot; ECG&#xD;
      recordings in patients suspected to have STEMI, and&#xD;
&#xD;
      Determine the possibility of pooling the data obtained from this study with data from other&#xD;
      institutions conducting identical studies, and developing a future and statistical analysis&#xD;
      plan to compare the sensitivity, specificity, positive predictive value and the negative&#xD;
      predictive power of the iPhone ECG, using a paired standard 12-lead ECG as the gold standard.&#xD;
&#xD;
      There will be no therapeutic interventions. A single research-related procedure will be&#xD;
      required, i.e., an iPhone ECG. Effort will be made to ensure that the performance of this&#xD;
      procedure will not delay any treatment and/or diagnostic procedures that are part of usual or&#xD;
      specialized care that the patient requires.&#xD;
&#xD;
      The individual patient's participation in the study will actually be only one day, i.e., the&#xD;
      day the informed consent is obtained and the two comparison ECGs will be done.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 29, 2016</start_date>
  <completion_date type="Actual">December 6, 2018</completion_date>
  <primary_completion_date type="Actual">January 30, 2018</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>Number of patients for whom the diagnoses (STEMI vs. non-STEMI) was in agreement between the standard 12-lead ECG and the iPhone &quot;12-lead equivalent&quot; ECG.</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>STEMI</condition>
  <arm_group>
    <arm_group_label>STEMI</arm_group_label>
    <description>Subjects in which a STEMI protocol has been initiated.&#xD;
An attempt will be made to do the standard 12-lead ECG first, followed immediately after by the Smartphone ECG&#xD;
If the initial standard 12-lead ECG was already obtained, such as when the patient was first diagnosed with STEMI, a repeat ECG will be performed at the same time as the Smartphone ECG&#xD;
If possible, the two ECGs will be taken in the Emergency Department, the critical care unit (CCU), or the catheterization laboratory just prior to cardiac catheterization. If not, then the two ECG's will be taken just after the cardiac catheterization is completed (i.e., within one hour of the procedure) while the patient is still in the catheterization laboratory and waiting for transport to the CCU&#xD;
Both ECGs will be sent to the designated ECG reading station, to be read and evaluated by three independent cardiologists</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chest Pain</arm_group_label>
    <description>Subjects presenting at the emergency department with chest pain.&#xD;
An attempt will be made to do the standard 12-lead ECG first, followed immediately after by the Smartphone ECG&#xD;
If the initial standard 12-lead ECG was already obtained, such as when the patient was first diagnosed with STEMI, a repeat ECG will be performed at the same time as the Smartphone ECG&#xD;
If possible, the two ECGs will be taken in the Emergency Department, the critical care unit (CCU), or the catheterization laboratory just prior to cardiac catheterization. If not, then the two ECG's will be taken just after the cardiac catheterization is completed (i.e., within one hour of the procedure) while the patient is still in the catheterization laboratory and waiting for transport to the CCU&#xD;
Both ECGs will be sent to the designated ECG reading station, to be read and evaluated by three independent cardiologists</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Smartphone ECG</intervention_name>
    <arm_group_label>Chest Pain</arm_group_label>
    <arm_group_label>STEMI</arm_group_label>
    <other_name>AliveCor Kardia Heart Monitor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard 12-lead ECG</intervention_name>
    <arm_group_label>Chest Pain</arm_group_label>
    <arm_group_label>STEMI</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male or female patients, &gt;18 years old, who are seen for chest pain, and/or patients for&#xD;
        whom the STEMI protocol has been activated, will be screened for this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to understand and sign a written informed consent form, which must be obtained&#xD;
             prior to initiation of any study procedures (patient or legally acceptable&#xD;
             representative).&#xD;
&#xD;
          -  Symptoms of chest pain upon presentation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability or refusal of the patient and/or the patient's legally-acceptable&#xD;
             representative to provide written informed consent for any reason.&#xD;
&#xD;
          -  Other conditions that in the opinion of the Principal Investigator or&#xD;
             Co-Investigator(s) may increase risk to the subject and/or compromise the quality of&#xD;
             the clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory W Barsness, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>December 6, 2018</last_update_submitted>
  <last_update_submitted_qc>December 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Gregory W. Barsness</investigator_full_name>
    <investigator_title>Consultant, Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Myocardial Infarction</keyword>
  <keyword>Ischemia</keyword>
  <keyword>Myocardial Ischemia</keyword>
  <keyword>Heart Diseases</keyword>
  <keyword>Cardiovascular Diseases</keyword>
  <keyword>Vascular Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03037229
org study id: 16-004793
nct id: NCT03037229
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Is the Smartphone ECG (electrocardiogram) an acceptable replacement for a standard ECG in the
      identification of STEMI (ST Elevation Myocardial Infarction).
The primary objective of this study is to determine if the Smartphone electrocardiogram (ECG)
      is an acceptable replacement for a standard ECG in the identification of ST Elevation
      Myocardial Infarction (STEMI).

      Toward this objective, this study involves the following:

      Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone "12-lead equivalent"
      ECG on patients presenting with chest pain in which the STEMI protocol was activated.

      Obtain simultaneous recordings of a standard 12-lead ECG and the iPhone "12-lead equivalent"
      ECG on patients presenting to the Emergency Department for evaluation of chest pain, not
      necessarily presenting with STEMI.

      Reading of ECGs (standard 12-lead and iPhone) by three independent cardiologists, who are
      blinded to the initial clinical ECG readings, the type of ECG equipment used, and the
      patient's clinical information.

      Assess the operational feasibility of using the Smartphone to obtain "12-lead equivalent" ECG
      recordings in patients suspected to have STEMI, and

      Determine the possibility of pooling the data obtained from this study with data from other
      institutions conducting identical studies, and developing a future and statistical analysis
      plan to compare the sensitivity, specificity, positive predictive value and the negative
      predictive power of the iPhone ECG, using a paired standard 12-lead ECG as the gold standard.

      There will be no therapeutic interventions. A single research-related procedure will be
      required, i.e., an iPhone ECG. Effort will be made to ensure that the performance of this
      procedure will not delay any treatment and/or diagnostic procedures that are part of usual or
      specialized care that the patient requires.

      The individual patient's participation in the study will actually be only one day, i.e., the
      day the informed consent is obtained and the two comparison ECGs will be done.
observational model: Case-Only
time perspective: Prospective
measure: Number of patients for whom the diagnoses (STEMI vs. non-STEMI) was in agreement between the standard 12-lead ECG and the iPhone "12-lead equivalent" ECG.
time frame: Day 1
arm group label: STEMI
description: Subjects in which a STEMI protocol has been initiated.
An attempt will be made to do the standard 12-lead ECG first, followed immediately after by the Smartphone ECG
If the initial standard 12-lead ECG was already obtained, such as when the patient was first diagnosed with STEMI, a repeat ECG will be performed at the same time as the Smartphone ECG
If possible, the two ECGs will be taken in the Emergency Department, the critical care unit (CCU), or the catheterization laboratory just prior to cardiac catheterization. If not, then the two ECG's will be taken just after the cardiac catheterization is completed (i.e., within one hour of the procedure) while the patient is still in the catheterization laboratory and waiting for transport to the CCU
Both ECGs will be sent to the designated ECG reading station, to be read and evaluated by three independent cardiologists
arm group label: Chest Pain
description: Subjects presenting at the emergency department with chest pain.
An attempt will be made to do the standard 12-lead ECG first, followed immediately after by the Smartphone ECG
If the initial standard 12-lead ECG was already obtained, such as when the patient was first diagnosed with STEMI, a repeat ECG will be performed at the same time as the Smartphone ECG
If possible, the two ECGs will be taken in the Emergency Department, the critical care unit (CCU), or the catheterization laboratory just prior to cardiac catheterization. If not, then the two ECG's will be taken just after the cardiac catheterization is completed (i.e., within one hour of the procedure) while the patient is still in the catheterization laboratory and waiting for transport to the CCU
Both ECGs will be sent to the designated ECG reading station, to be read and evaluated by three independent cardiologists
intervention type: Device
intervention name: Smartphone ECG
arm group label: Chest Pain
arm group label: STEMI
other name: AliveCor Kardia Heart Monitor
intervention type: Device
intervention name: Standard 12-lead ECG
arm group label: Chest Pain
arm group label: STEMI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gregory W Barsness, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Gregory W. Barsness
investigator title: Consultant, Assistant Professor of Medicine
mesh term: Myocardial Infarction
mesh term: ST Elevation Myocardial Infarction
mesh term: Infarction
sharing ipd: No