The HeartRunner Trial

NCT ID: NCT03835403

Last Updated: 2022-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-15
• Study Completion Date: 2026-05-31

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.

Conditions

Out-Of-Hospital Cardiac Arrest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Usual Care (control arm)

These cardiac arrests will receive standard EMS response.

Group Type: NO_INTERVENTION

No interventions assigned to this group

HeartRunner Activation

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

Group Type: EXPERIMENTAL

Activation of HeartRunners

Intervention Type: OTHER

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

Interventions

Activation of HeartRunners

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

Intervention Type: OTHER

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

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.

• Minimum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TrygFonden, Denmark

INDUSTRY

Sponsor Role: collaborator

Emergency Medical Services, Capital Region, Denmark

OTHER_GOV

Sponsor Role: lead

Responsible Party

Fredrik Folke

MD, PhD, Head of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fredrik Folke, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Copenhagen EMS

Locations

Emergency Medical Services Copenhagen

Copenhagen, Ballerup, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Fredrik Folke, MD, PhD

Role: CONTACT

ff@heart.dk

+45 28182978

Carolina Malta Hansen, MD, PhD

Role: CONTACT

carolina.malta.hansen.01@regionh.dk

+4560126127

Facility Contacts

Carolina Malta Hansen, MD, PhD

Role: primary

carolina.malta.hansen.01@regionh.dk

References

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.

Reference Type: DERIVED

PMID: 35060395 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32616162 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: Updated protocol

View Document

Document Type: Study Protocol: Changes to protocol

View Document

Document Type: Statistical Analysis Plan: Detailed Final Statistical Analysis Plan

View Document

Other Identifiers

The HeartRunner Trial

Identifier Type: -

Identifier Source: org_study_id