NCT03835403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,114

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

6.8 years

First QC Date

February 7, 2019

Last Update Submit

May 14, 2026

Conditions

Out-Of-Hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • 30-day survival

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

    30 days after date of out-of-hospital cardiac arrest

Secondary Outcomes (5)

  • Rates of bystander defibrillation

    During cardiac arrest

  • Rates of bystander cardiopulmonary resuscitation

    During cardiac arrest

  • Rates of return of spontaneuous circulation

    Immediately after out-of-hospital cardiac arrest

  • Rates of survival after 1 year

    1 year after date of out-of-hospital cardiac arrest

  • Rates of neurological intact survival

    At hospital discharge

Study Arms (2)

Usual Care (control arm)

NO INTERVENTION

These cardiac arrests will receive standard EMS response.

HeartRunner Activation

EXPERIMENTAL

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

Other: Activation of HeartRunners

Interventions

Activation of HeartRunnersOTHER

Activation of volunteer citizen first-responders to respond to nearby cardiac arrests

HeartRunner Activation

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Medical Services Copenhagen

Copenhagen, Ballerup, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 35060395DERIVED

  • 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.

    PMID: 32616162DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Fredrik Folke, MD, PhD

    Copenhagen EMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Head of Research

Study Record Dates

First Submitted

February 7, 2019

First Posted

February 8, 2019

Study Start

May 15, 2019

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)