CompletedNot Applicable

The HeartRunner Trial

Denmark2,114 participantsStarted 2019-05-15

Plain-language 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.

Who can participate

Age range

8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial looked at 30-day survival after out-of-hospital cardiac arrest — do you know what the results showed, and would those findings change how my care or emergency response plan is handled?
2The trial involved bystander or first-responder response to cardiac arrest outside the hospital — can you explain how the approach tested here compares to what would actually happen in my community if I had a cardiac arrest?
3Since this trial is now completed, has the intervention it studied become part of standard emergency protocols in our area, or is it still considered experimental?
4Out-of-hospital cardiac arrest survival depends heavily on what happens in the first few minutes — based on this trial's findings, is there anything I or my family should be doing differently to be prepared, like learning CPR or knowing where nearby defibrillators are?
5Are there other completed or ongoing trials addressing out-of-hospital cardiac arrest survival that my care team thinks are more relevant to my specific situation than this one?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

30-day survival

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

Trial details

NCT IDNCT03835403

SponsorEmergency Medical Services, Capital Region, Denmark

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-03-01

View on ClinicalTrials.gov More Out-Of-Hospital Cardiac Arrest trials