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The HeartRunner Trial

Primary Purpose

Out-Of-Hospital Cardiac Arrest

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Activation of HeartRunners
Sponsored by
Emergency Medical Services, Capital Region, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Out-Of-Hospital Cardiac Arrest

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emergency Medical Services CopenhagenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care (control arm)

HeartRunner Activation

Arm Description

These cardiac arrests will receive standard EMS response.

For these cardiac arrests, HeartRunners will be activated in addition to standard EMS response.

Outcomes

Primary Outcome Measures

30-day survival
Patient alive 30 days after date of out-of-hospital cardiac arrest

Secondary Outcome Measures

Rates of bystander defibrillation
Percentage of patients who received defibrillation prior to EMS arrival
Rates of bystander cardiopulmonary resuscitation
Percentage of patients who received bystander cardiopulmonary resuscitation prior to EMS arrival
Rates of return of spontaneuous circulation
sustained circulation indicating successful resuscitation
Rates of survival after 1 year
percentage of patients alive 1 year after out-of-hospital cardiac arrest
Rates of neurological intact survival
percentage of patients with cerebral performance category score of 1-2

Full Information

First Posted
February 7, 2019
Last Updated
December 7, 2022
Sponsor
Emergency Medical Services, Capital Region, Denmark
Collaborators
TrygFonden, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT03835403
Brief Title
The HeartRunner Trial
Official Title
Public Access Defibrillation by Activated Citizen First-responders - The HeartRunner Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emergency Medical Services, Capital Region, Denmark
Collaborators
TrygFonden, Denmark

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-Of-Hospital Cardiac Arrest

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care (control arm)
Arm Type
No Intervention
Arm Description
These cardiac arrests will receive standard EMS response.
Arm Title
HeartRunner Activation
Arm Type
Experimental
Arm Description
For these cardiac arrests, HeartRunners will be activated in addition to standard EMS response.
Intervention Type
Other
Intervention Name(s)
Activation of HeartRunners
Intervention Description
Activation of volunteer citizen first-responders to respond to nearby cardiac arrests
Primary Outcome Measure Information:
Title
30-day survival
Description
Patient alive 30 days after date of out-of-hospital cardiac arrest
Time Frame
30 days after date of out-of-hospital cardiac arrest
Secondary Outcome Measure Information:
Title
Rates of bystander defibrillation
Description
Percentage of patients who received defibrillation prior to EMS arrival
Time Frame
During cardiac arrest
Title
Rates of bystander cardiopulmonary resuscitation
Description
Percentage of patients who received bystander cardiopulmonary resuscitation prior to EMS arrival
Time Frame
During cardiac arrest
Title
Rates of return of spontaneuous circulation
Description
sustained circulation indicating successful resuscitation
Time Frame
Immediately after out-of-hospital cardiac arrest
Title
Rates of survival after 1 year
Description
percentage of patients alive 1 year after out-of-hospital cardiac arrest
Time Frame
1 year after date of out-of-hospital cardiac arrest
Title
Rates of neurological intact survival
Description
percentage of patients with cerebral performance category score of 1-2
Time Frame
At hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fredrik Folke, MD, PhD
Phone
+45 28182978
Email
ff@heart.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Carolina Malta Hansen, MD, PhD
Phone
+4560126127
Email
carolina.malta.hansen.01@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredrik Folke, MD, PhD
Organizational Affiliation
Copenhagen EMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emergency Medical Services Copenhagen
City
Copenhagen
State/Province
Ballerup
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Malta Hansen, MD, PhD
Email
carolina.malta.hansen.01@regionh.dk
First Name & Middle Initial & Last Name & Degree
Fredrik Folke, MD, PhD
First Name & Middle Initial & Last Name & Degree
Linn C Andelius, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35060395
Citation
Mottlau KH, Andelius LC, Gregersen R, Malta Hansen C, Folke F. Citizen Responder Activation in Out-of-Hospital Cardiac Arrest by Time of Day and Day of Week. J Am Heart Assoc. 2022 Feb;11(3):e023413. doi: 10.1161/JAHA.121.023413. Epub 2022 Jan 21.
Results Reference
derived
PubMed Identifier
32616162
Citation
Andelius L, Malta Hansen C, Lippert FK, Karlsson L, Torp-Pedersen C, Kjaer Ersboll A, Kober L, Collatz Christensen H, Blomberg SN, Gislason GH, Folke F. Smartphone Activation of Citizen Responders to Facilitate Defibrillation in Out-of-Hospital Cardiac Arrest. J Am Coll Cardiol. 2020 Jul 7;76(1):43-53. doi: 10.1016/j.jacc.2020.04.073.
Results Reference
derived

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The HeartRunner Trial

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