<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/NCT03835403</url>
  </required_header>
  <id_info>
    <org_study_id>The HeartRunner Trial</org_study_id>
    <nct_id>NCT03835403</nct_id>
  </id_info>
  <brief_title>The HeartRunner Trial</brief_title>
  <official_title>Public Access Defibrillation by Activated Citizen First-responders - The HeartRunner Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emergency Medical Services, Capital Region, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>TrygFonden, Denmark</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Emergency Medical Services, Capital Region, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will assess 30-day survival for cases where volunteer citizen responders ('heart&#xD;
      runners') were activated through a smartphone app to retrieve an AED in case of suspected&#xD;
      out-of-hospital cardiac arrest (OHCA) versus standard emergency medical services care. The&#xD;
      study will randomize emergency medical dispatch center incoming calls which are suspected&#xD;
      out-of-hospital cardiac arrest, such that half will be randomized to activation of heart&#xD;
      runners and half to no activation of heart runners (standard care). The study will also&#xD;
      assess physical or psychological risks involved for the activated heart runners.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chances of survival after out-of-hospital cardiac arrest decrease 10% per minute from&#xD;
      collapse until defibrillation. Activating volunteer citizens through the emergency medical&#xD;
      dispatch center can potentially increase rates of bystander defibrillation and survival. The&#xD;
      HeartRunner trial will investigage the effect of activating registered volunteer citizens&#xD;
      through a mobile app integrated with the emergency medical services on 30-day survival&#xD;
      following out-of-hospital cardiac arrest. Both arms will receive standard care by the&#xD;
      Emergency Medical Services. The intervention arm will additionally receive the activation of&#xD;
      volunteer citizen responders. The randomization will take place independently in 3 different&#xD;
      strata according to heart runner distance to OHCA (&lt; 3 min, 3-9 min, &gt; 9 min). The trial will&#xD;
      also assess whether it is safe, both physically and psychologically, to activate volunteer&#xD;
      citizen responders to respond to out-of-hospital cardiac arrests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 15, 2019</start_date>
  <completion_date type="Anticipated">May 2026</completion_date>
  <primary_completion_date type="Anticipated">May 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>30-day survival</measure>
    <time_frame>30 days after date of out-of-hospital cardiac arrest</time_frame>
    <description>Patient alive 30 days after date of out-of-hospital cardiac arrest</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rates of bystander defibrillation</measure>
    <time_frame>During cardiac arrest</time_frame>
    <description>Percentage of patients who received defibrillation prior to EMS arrival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of bystander cardiopulmonary resuscitation</measure>
    <time_frame>During cardiac arrest</time_frame>
    <description>Percentage of patients who received bystander cardiopulmonary resuscitation prior to EMS arrival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of return of spontaneuous circulation</measure>
    <time_frame>Immediately after out-of-hospital cardiac arrest</time_frame>
    <description>sustained circulation indicating successful resuscitation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of survival after 1 year</measure>
    <time_frame>1 year after date of out-of-hospital cardiac arrest</time_frame>
    <description>percentage of patients alive 1 year after out-of-hospital cardiac arrest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of neurological intact survival</measure>
    <time_frame>At hospital discharge</time_frame>
    <description>percentage of patients with cerebral performance category score of 1-2</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1600</enrollment>
  <condition>Out-Of-Hospital Cardiac Arrest</condition>
  <arm_group>
    <arm_group_label>Usual Care (control arm)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These cardiac arrests will receive standard EMS response.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HeartRunner Activation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For these cardiac arrests, HeartRunners will be activated in addition to standard EMS response.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Activation of HeartRunners</intervention_name>
    <description>Activation of volunteer citizen first-responders to respond to nearby cardiac arrests</description>
    <arm_group_label>HeartRunner Activation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All out-of-hospital cardiac arrests recognized by Emergency Medical Dispatcher and&#xD;
             where the HeartRunner system is activated.&#xD;
&#xD;
          -  Non-traumatic etiology, this excludes intoxication, drowning or suicide.&#xD;
&#xD;
          -  Age &gt; 7 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Caller is not in direct contact with the patient&#xD;
&#xD;
          -  If Emergency Medical Dispatcher deems AED is not indicated, e.g., in nursing homes&#xD;
             where trained personal is present.&#xD;
&#xD;
          -  OHCAs not treated by the EMS due to ethical reasons or obvious signs of death&#xD;
&#xD;
          -  OHCAs with no heart runners within 1800 meters&#xD;
&#xD;
          -  Not true cardiac arrest (suspected, but not verified)&#xD;
&#xD;
          -  EMS-witnessed OHCAs&#xD;
&#xD;
        Emergency medical dispatchers are instructed not to activate heart runners in case any of&#xD;
        the exclusion criteria above. However, since it can be challenging for emergency medical&#xD;
        dispatchers to gather sufficient information about the patient within the first few&#xD;
        minutes, heart runners will admittedly be activated even though they should not have been.&#xD;
        Since randomization will occur for all cases in which a heart runner is activated, cases&#xD;
        with any of the exclusion criteria will be secondarily excluded.&#xD;
&#xD;
        These cases will be accounted for but not included in analyses of outcome. Our pilot study&#xD;
        showed approximately 60% of suspected cardiac arrests were true cardiac arrests. Therefore,&#xD;
        we expect 40% of cases for which heart runners were dispatched not to be true cardiac&#xD;
        arrests.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fredrik Folke, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Copenhagen EMS</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fredrik Folke, MD, PhD</last_name>
    <phone>+45 28182978</phone>
    <email>ff@heart.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carolina Malta Hansen, MD, PhD</last_name>
    <phone>+4560126127</phone>
    <email>carolina.malta.hansen.01@regionh.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Emergency Medical Services Copenhagen</name>
      <address>
        <city>Copenhagen</city>
        <state>Ballerup</state>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carolina Malta Hansen, MD, PhD</last_name>
      <email>carolina.malta.hansen.01@regionh.dk</email>
    </contact>
    <investigator>
      <last_name>Fredrik Folke, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Linn C Andelius, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>December 7, 2022</last_update_submitted>
  <last_update_submitted_qc>December 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emergency Medical Services, Capital Region, Denmark</investigator_affiliation>
    <investigator_full_name>Fredrik Folke</investigator_full_name>
    <investigator_title>MD, PhD, Head of Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Out-of-Hospital Cardiac Arrest</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan: Updated protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT03835403/Prot_SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Changes to protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT03835403/Prot_004.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan: Detailed Final Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/03/NCT03835403/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03835403
org study id: The HeartRunner Trial
nct id: NCT03835403
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The study will assess 30-day survival for cases where volunteer citizen responders ('heart
      runners') were activated through a smartphone app to retrieve an AED in case of suspected
      out-of-hospital cardiac arrest (OHCA) versus standard emergency medical services care. The
      study will randomize emergency medical dispatch center incoming calls which are suspected
      out-of-hospital cardiac arrest, such that half will be randomized to activation of heart
      runners and half to no activation of heart runners (standard care). The study will also
      assess physical or psychological risks involved for the activated heart runners.
Chances of survival after out-of-hospital cardiac arrest decrease 10% per minute from
      collapse until defibrillation. Activating volunteer citizens through the emergency medical
      dispatch center can potentially increase rates of bystander defibrillation and survival. The
      HeartRunner trial will investigage the effect of activating registered volunteer citizens
      through a mobile app integrated with the emergency medical services on 30-day survival
      following out-of-hospital cardiac arrest. Both arms will receive standard care by the
      Emergency Medical Services. The intervention arm will additionally receive the activation of
      volunteer citizen responders. The randomization will take place independently in 3 different
      strata according to heart runner distance to OHCA (< 3 min, 3-9 min, > 9 min). The trial will
      also assess whether it is safe, both physically and psychologically, to activate volunteer
      citizen responders to respond to out-of-hospital cardiac arrests.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: 30-day survival
time frame: 30 days after date of out-of-hospital cardiac arrest
description: Patient alive 30 days after date of out-of-hospital cardiac arrest
measure: Rates of bystander defibrillation
time frame: During cardiac arrest
description: Percentage of patients who received defibrillation prior to EMS arrival
measure: Rates of bystander cardiopulmonary resuscitation
time frame: During cardiac arrest
description: Percentage of patients who received bystander cardiopulmonary resuscitation prior to EMS arrival
measure: Rates of return of spontaneuous circulation
time frame: Immediately after out-of-hospital cardiac arrest
description: sustained circulation indicating successful resuscitation
measure: Rates of survival after 1 year
time frame: 1 year after date of out-of-hospital cardiac arrest
description: percentage of patients alive 1 year after out-of-hospital cardiac arrest
measure: Rates of neurological intact survival
time frame: At hospital discharge
description: percentage of patients with cerebral performance category score of 1-2
arm group label: Usual Care (control arm)
arm group type: No Intervention
description: These cardiac arrests will receive standard EMS response.
arm group label: HeartRunner Activation
arm group type: Experimental
description: For these cardiac arrests, HeartRunners will be activated in addition to standard EMS response.
intervention type: Other
intervention name: Activation of HeartRunners
description: Activation of volunteer citizen first-responders to respond to nearby cardiac arrests
arm group label: HeartRunner Activation
criteria: 
gender: All
minimum age: 8 Years
maximum age: N/A
healthy volunteers: No
last name: Fredrik Folke, MD, PhD
role: Principal Investigator
affiliation: Copenhagen EMS
last name: Fredrik Folke, MD, PhD
phone: +45 28182978
email: ff@heart.dk
last name: Carolina Malta Hansen, MD, PhD
phone: +4560126127
email: carolina.malta.hansen.01@regionh.dk
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Emergency Medical Services, Capital Region, Denmark
investigator full name: Fredrik Folke
investigator title: MD, PhD, Head of Research
mesh term: Out-of-Hospital Cardiac Arrest
sharing ipd: No
provided document: 
provided document: 
provided document: 