The HeartRunner Trial

Out-Of-Hospital Cardiac Arrest Clinical Trial

Official title:

Public Access Defibrillation by Activated Citizen First-responders - The HeartRunner Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03835403
• Other study ID #: The HeartRunner Trial
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: May 2026

Study information

• Verified date: December 2022
• Source: Emergency Medical Services, Capital Region, Denmark
• Contact: Fredrik Folke, MD, PhD
• Phone: +45 28182978
• Email: ff[@]heart.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Out-Of-Hospital Cardiac Arrest

Intervention

Other:
• Activation of HeartRunners
Activation of volunteer citizen first-responders to respond to nearby cardiac arrests

Locations

Country	Name	City	State
Denmark	Emergency Medical Services Copenhagen	Copenhagen	Ballerup

Sponsors (2)

Lead Sponsor	Collaborator
Emergency Medical Services, Capital Region, Denmark	TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rates of bystander defibrillation	Percentage of patients who received defibrillation prior to EMS arrival	During cardiac arrest
Secondary	Rates of bystander cardiopulmonary resuscitation	Percentage of patients who received bystander cardiopulmonary resuscitation prior to EMS arrival	During cardiac arrest
Secondary	Rates of return of spontaneuous circulation	sustained circulation indicating successful resuscitation	Immediately after out-of-hospital cardiac arrest
Secondary	Rates of survival after 1 year	percentage of patients alive 1 year after out-of-hospital cardiac arrest	1 year after date of out-of-hospital cardiac arrest
Secondary	Rates of neurological intact survival	percentage of patients with cerebral performance category score of 1-2	At hospital discharge