<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/NCT04446585</url>
  </required_header>
  <id_info>
    <org_study_id>111</org_study_id>
    <nct_id>NCT04446585</nct_id>
  </id_info>
  <brief_title>Cardiac Arrest in Residential Areas With Mobile First-responder Activation</brief_title>
  <acronym>CARAMBA</acronym>
  <official_title>A Cluster Randomized Clinical Trial of Strategic AED Deployment in High-risk Residential Areas Combined With Activation of Local Residents</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>
    <collaborator>
      <agency>Zoll Medical Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Danish Heart Foundation</agency>
      <agency_class>Other</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>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to increase proportions of bystander defibrillation during out-of-hospital&#xD;
      cardiac arrest (hereof referred to as cardiac arrest) in residential areas with a high&#xD;
      density of cardiac arrests. The intervention consists of Automated External Defibrillators&#xD;
      (AEDs) and residents' involvement in resuscitation through training and enrollment as citizen&#xD;
      responders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Survival decreases by 10% for every minute that passes after a cardiac arrest until&#xD;
      defibrillation. Despite an increasing number of available AEDs, survival and defibrillation&#xD;
      rates in residential areas remain poor. Efforts to increase bystander defibrillation has the&#xD;
      potential to improve survival. Through the strategic deployment of AEDs, training, and&#xD;
      recruitment of residents as citizen responders, we aim to improve proportions of bystander&#xD;
      defibrillation and 30-day survival in densely populated residential areas with a high density&#xD;
      of cardiac arrests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2021</start_date>
  <completion_date type="Anticipated">January 2027</completion_date>
  <primary_completion_date type="Anticipated">January 2027</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>Single (Outcomes Assessor)</masking>
    <masking_description>Due to the nature of the study, treatment allocation is not masked to rescuers or patients. The steering committee will, during the study, receive information on total numbers of arrests and overall success of providing defibrillation. The steering committee will not receive information on whether defibrillation took place in areas allocated to intervention or no intervention. Only the safety committee will have access to all information.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Bystander defibrillation</measure>
    <time_frame>Up to five years after implementation of the intervention</time_frame>
    <description>Proportion of bystander defibrillation of witnessed cardiac arrests</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>30-day survival</measure>
    <time_frame>30 days after date of cardiac arrest</time_frame>
    <description>Proportion of patients alive 30 days after date of cardiac arrest</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">260</enrollment>
  <condition>Out-Of-Hospital Cardiac Arrest</condition>
  <arm_group>
    <arm_group_label>Control sites</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>For all 1-1-2 calls with suspected cardiac arrest to the emergency dispatch center will activate a two-tiered response consisting of dispatch of an ambulance with an emergency medical technician, a physician-staffed mobile emergency care unit, and citizen first responders through the Heart Runner app.&#xD;
The medical dispatcher offers telephone assisted cardiopulmonary resuscitation (CPR) to bystanders. Furthermore, if more than two bystanders are present and an AED is accessible within 1½ minute travel distance (depending on the type of terrain), then one bystander is guided to localize and retrieve the AED.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention sites</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>As a supplement to the standard care as described in the control arm, the following will be supplied:&#xD;
Strategical deployment of AEDs with 24:7 availability and 1½ minute walking distance to every residence within the area. The AEDs will be registered with the AED network and thus linked to the emergency dispatch center.&#xD;
The emergency dispatch center will retrieve data from used AEDs.&#xD;
For each interventional area, approximately 120 residents will receive a course in CPR and AED use and subsequently be recruited as citizen responders so that they can be activated through the HeartRunner app in case of a nearby cardiac arrest.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Automated External Defibrillator (AED)</intervention_name>
    <description>Deployment of AEDs</description>
    <arm_group_label>Intervention sites</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Training in cardiopulmonary resuscitation and AED use</intervention_name>
    <description>Residents will undergo 30-minute courses at study start and if needed during the trial period. During the course they will also be recruited as citizen responders</description>
    <arm_group_label>Intervention sites</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Activation of citizen responders</intervention_name>
    <description>Citizen responders will be activated in case of suspected cardiac arrest through the heart runner app.</description>
    <arm_group_label>Intervention sites</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All witnessed cardiac arrests recognized registered in the Danish Cardiac Arrest&#xD;
             Registry occurring within the study sites. This excludes non witnessed cardiac&#xD;
             arrests.&#xD;
&#xD;
          -  Witnessed cardiac arrest&#xD;
&#xD;
          -  Non-traumatic etiology, this excludes intoxication, drowning or suicide.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac arrest occurring in a nursing home&#xD;
&#xD;
          -  Cardiac arrest not treated by the EMS due to ethical reasons or obvious signs of death&#xD;
&#xD;
          -  Not true cardiac arrest (suspected, but not verified)&#xD;
&#xD;
          -  Cardiac arrests witnessed by the emergency medical personnel&#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>EMS Copenhagen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carolina M Hansen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>EMS Copenhagen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anne J Jørgensen, MD</last_name>
    <phone>+45 60 62 91 14</phone>
    <email>anne.juul.joergensen.02@regionh.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fredrik Folke, MD, PhD</last_name>
    <phone>+45 28 18 29 78</phone>
    <email>ff@heart.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Emergency Medical Services Copenhagen</name>
      <address>
        <city>Ballerup</city>
        <state>The Capital Region</state>
        <zip>2750</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne J Jørgensen, MD</last_name>
      <phone>+45 60 62 91 14</phone>
      <email>anne.juul.joergensen.02@regionh.dk</email>
    </contact>
    <investigator>
      <last_name>Fredrik Folke, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Carolina M Hansen, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anne J Jørgensen, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2023</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>M.D., PhD, Professor</investigator_title>
  </responsible_party>
  <keyword>Suddan cardiac arrest</keyword>
  <keyword>Heart Arrest</keyword>
  <keyword>Heart Diseases</keyword>
  <keyword>Cardiovascular Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
    <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</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>January 8, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/85/NCT04446585/Prot_SAP_001.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/NCT04446585
org study id: 111
nct id: NCT04446585
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The study aims to increase proportions of bystander defibrillation during out-of-hospital
      cardiac arrest (hereof referred to as cardiac arrest) in residential areas with a high
      density of cardiac arrests. The intervention consists of Automated External Defibrillators
      (AEDs) and residents' involvement in resuscitation through training and enrollment as citizen
      responders.
Survival decreases by 10% for every minute that passes after a cardiac arrest until
      defibrillation. Despite an increasing number of available AEDs, survival and defibrillation
      rates in residential areas remain poor. Efforts to increase bystander defibrillation has the
      potential to improve survival. Through the strategic deployment of AEDs, training, and
      recruitment of residents as citizen responders, we aim to improve proportions of bystander
      defibrillation and 30-day survival in densely populated residential areas with a high density
      of cardiac arrests.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Due to the nature of the study, treatment allocation is not masked to rescuers or patients. The steering committee will, during the study, receive information on total numbers of arrests and overall success of providing defibrillation. The steering committee will not receive information on whether defibrillation took place in areas allocated to intervention or no intervention. Only the safety committee will have access to all information.
measure: Bystander defibrillation
time frame: Up to five years after implementation of the intervention
description: Proportion of bystander defibrillation of witnessed cardiac arrests
measure: 30-day survival
time frame: 30 days after date of cardiac arrest
description: Proportion of patients alive 30 days after date of cardiac arrest
arm group label: Control sites
arm group type: No Intervention
description: For all 1-1-2 calls with suspected cardiac arrest to the emergency dispatch center will activate a two-tiered response consisting of dispatch of an ambulance with an emergency medical technician, a physician-staffed mobile emergency care unit, and citizen first responders through the Heart Runner app.
The medical dispatcher offers telephone assisted cardiopulmonary resuscitation (CPR) to bystanders. Furthermore, if more than two bystanders are present and an AED is accessible within 1½ minute travel distance (depending on the type of terrain), then one bystander is guided to localize and retrieve the AED.
arm group label: Intervention sites
arm group type: Experimental
description: As a supplement to the standard care as described in the control arm, the following will be supplied:
Strategical deployment of AEDs with 24:7 availability and 1½ minute walking distance to every residence within the area. The AEDs will be registered with the AED network and thus linked to the emergency dispatch center.
The emergency dispatch center will retrieve data from used AEDs.
For each interventional area, approximately 120 residents will receive a course in CPR and AED use and subsequently be recruited as citizen responders so that they can be activated through the HeartRunner app in case of a nearby cardiac arrest.
intervention type: Device
intervention name: Automated External Defibrillator (AED)
description: Deployment of AEDs
arm group label: Intervention sites
intervention type: Other
intervention name: Training in cardiopulmonary resuscitation and AED use
description: Residents will undergo 30-minute courses at study start and if needed during the trial period. During the course they will also be recruited as citizen responders
arm group label: Intervention sites
intervention type: Other
intervention name: Activation of citizen responders
description: Citizen responders will be activated in case of suspected cardiac arrest through the heart runner app.
arm group label: Intervention sites
criteria: 
gender: All
minimum age: 8 Years
maximum age: N/A
healthy volunteers: No
last name: Fredrik Folke, MD, PhD
role: Principal Investigator
affiliation: EMS Copenhagen
last name: Carolina M Hansen, MD, PhD
role: Principal Investigator
affiliation: EMS Copenhagen
last name: Anne J Jørgensen, MD
phone: +45 60 62 91 14
email: anne.juul.joergensen.02@regionh.dk
last name: Fredrik Folke, MD, PhD
phone: +45 28 18 29 78
email: ff@heart.dk
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Emergency Medical Services, Capital Region, Denmark
investigator full name: Fredrik Folke
investigator title: M.D., PhD, Professor
mesh term: Heart Arrest
mesh term: Out-of-Hospital Cardiac Arrest
sharing ipd: No
provided document: 