The HeartRunner Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03835403|
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : December 8, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Out-Of-Hospital Cardiac Arrest||Other: Activation of HeartRunners||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Public Access Defibrillation by Activated Citizen First-responders - The HeartRunner Trial|
|Actual Study Start Date :||May 15, 2019|
|Estimated Primary Completion Date :||May 2026|
|Estimated Study Completion Date :||May 2026|
No Intervention: Usual Care (control arm)
These cardiac arrests will receive standard EMS response.
Experimental: HeartRunner Activation
For these cardiac arrests, HeartRunners will be activated in addition to standard EMS response.
Other: Activation of HeartRunners
Activation of volunteer citizen first-responders to respond to nearby cardiac arrests
- 30-day survival [ Time Frame: 30 days after date of out-of-hospital cardiac arrest ]Patient alive 30 days after date of out-of-hospital cardiac arrest
- Rates of bystander defibrillation [ Time Frame: During cardiac arrest ]Percentage of patients who received defibrillation prior to EMS arrival
- Rates of bystander cardiopulmonary resuscitation [ Time Frame: During cardiac arrest ]Percentage of patients who received bystander cardiopulmonary resuscitation prior to EMS arrival
- Rates of return of spontaneuous circulation [ Time Frame: Immediately after out-of-hospital cardiac arrest ]sustained circulation indicating successful resuscitation
- Rates of survival after 1 year [ Time Frame: 1 year after date of out-of-hospital cardiac arrest ]percentage of patients alive 1 year after out-of-hospital cardiac arrest
- Rates of neurological intact survival [ Time Frame: At hospital discharge ]percentage of patients with cerebral performance category score of 1-2
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||8 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835403
|Contact: Fredrik Folke, MD, PhD||+45 firstname.lastname@example.org|
|Contact: Carolina Malta Hansen, MD, PhDemail@example.com|
|Emergency Medical Services Copenhagen||Recruiting|
|Copenhagen, Ballerup, Denmark|
|Contact: Carolina Malta Hansen, MD, PhD firstname.lastname@example.org|
|Principal Investigator: Fredrik Folke, MD, PhD|
|Sub-Investigator: Linn C Andelius, MD|
|Principal Investigator:||Fredrik Folke, MD, PhD||Copenhagen EMS|
Documents provided by Fredrik Folke, Emergency Medical Services, Capital Region, Denmark:
|Responsible Party:||Fredrik Folke, MD, PhD, Head of Research, Emergency Medical Services, Capital Region, Denmark|
|Other Study ID Numbers:||
The HeartRunner Trial
|First Posted:||February 8, 2019 Key Record Dates|
|Last Update Posted:||December 8, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|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|
Out-of-Hospital Cardiac Arrest