We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The HeartRunner Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03835403
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : December 8, 2022
Sponsor:
Collaborator:
TrygFonden, Denmark
Information provided by (Responsible Party):
Fredrik Folke, Emergency Medical Services, Capital Region, Denmark

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Out-Of-Hospital Cardiac Arrest Other: Activation of HeartRunners Not Applicable

Detailed Description:
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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Public Access Defibrillation by Activated Citizen First-responders - The HeartRunner Trial
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
No Intervention: Usual Care (control arm)
These cardiac arrests will receive standard EMS response.
Experimental: HeartRunner Activation
For these cardiac arrests, HeartRunners will be activated in addition to standard EMS response.
 Other: Activation of HeartRunners
Activation of volunteer citizen first-responders to respond to nearby cardiac arrests


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 30-day survival [ Time Frame: 30 days after date of out-of-hospital cardiac arrest ]
    Patient alive 30 days after date of out-of-hospital cardiac arrest


Secondary Outcome Measures :
  1. Rates of bystander defibrillation [ Time Frame: During cardiac arrest ]
    Percentage of patients who received defibrillation prior to EMS arrival

  2. Rates of bystander cardiopulmonary resuscitation [ Time Frame: During cardiac arrest ]
    Percentage of patients who received bystander cardiopulmonary resuscitation prior to EMS arrival

  3. Rates of return of spontaneuous circulation [ Time Frame: Immediately after out-of-hospital cardiac arrest ]
    sustained circulation indicating successful resuscitation

  4. Rates of survival after 1 year [ Time Frame: 1 year after date of out-of-hospital cardiac arrest ]
    percentage of patients alive 1 year after out-of-hospital cardiac arrest

  5. Rates of neurological intact survival [ Time Frame: At hospital discharge ]
    percentage of patients with cerebral performance category score of 1-2


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All out-of-hospital cardiac arrests recognized by Emergency Medical Dispatcher and where the HeartRunner system is activated.
  • Non-traumatic etiology, this excludes intoxication, drowning or suicide.
  • Age > 7 years

Exclusion Criteria:

  • Caller is not in direct contact with the patient
  • If Emergency Medical Dispatcher deems AED is not indicated, e.g., in nursing homes where trained personal is present.
  • OHCAs not treated by the EMS due to ethical reasons or obvious signs of death
  • OHCAs with no heart runners within 1800 meters
  • Not true cardiac arrest (suspected, but not verified)
  • EMS-witnessed OHCAs

Emergency medical dispatchers are instructed not to activate heart runners in case any of the exclusion criteria above. However, since it can be challenging for emergency medical dispatchers to gather sufficient information about the patient within the first few minutes, heart runners will admittedly be activated even though they should not have been. Since randomization will occur for all cases in which a heart runner is activated, cases with any of the exclusion criteria will be secondarily excluded.

These cases will be accounted for but not included in analyses of outcome. Our pilot study showed approximately 60% of suspected cardiac arrests were true cardiac arrests. Therefore, we expect 40% of cases for which heart runners were dispatched not to be true cardiac arrests.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835403


Contacts
Layout table for location contacts
Contact: Fredrik Folke, MD, PhD +45 28182978 ff@heart.dk
Contact: Carolina Malta Hansen, MD, PhD +4560126127 carolina.malta.hansen.01@regionh.dk

Locations
Layout table for location information
Denmark
Emergency Medical Services Copenhagen Recruiting
Copenhagen, Ballerup, Denmark
Contact: Carolina Malta Hansen, MD, PhD       carolina.malta.hansen.01@regionh.dk   
Principal Investigator: Fredrik Folke, MD, PhD         
Sub-Investigator: Linn C Andelius, MD         
Sponsors and Collaborators
Emergency Medical Services, Capital Region, Denmark
TrygFonden, Denmark
Investigators
Layout table for investigator information
Principal Investigator: Fredrik Folke, MD, PhD Copenhagen EMS
  Study Documents (Full-Text)

Documents provided by Fredrik Folke, Emergency Medical Services, Capital Region, Denmark:
Study Protocol and Statistical Analysis Plan: Updated protocol  [PDF] December 3, 2020
Study Protocol: Changes to protocol  [PDF] December 3, 2020
Statistical Analysis Plan: Detailed Final Statistical Analysis Plan  [PDF] December 3, 2020

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Fredrik Folke, MD, PhD, Head of Research, Emergency Medical Services, Capital Region, Denmark
ClinicalTrials.gov Identifier: NCT03835403    
Other Study ID Numbers: The HeartRunner Trial
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: December 8, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Out-of-Hospital Cardiac Arrest
Heart Arrest
Heart Diseases
Cardiovascular Diseases