Not Yet RecruitingNot Applicable

The Impact of First Responder Intervention on Survival in Out-of-Hospital Cardiac Arrest in Emilia-Romagna Region

Italy5,200 participantsStarted 2026-05

Plain-language summary

Out-of-hospital cardiac arrest (OHCA) is a life-threatening emergency and one of the leading causes of death worldwide. Survival depends critically on how quickly help arrives and whether cardiopulmonary resuscitation (CPR) and defibrillation are started early. In recent years, many regions in Europe and Italy, including Emilia-Romagna, have introduced systems that alert nearby volunteers, called First Responders (FRs), through smartphone applications (such as DAE RespondER). These individuals can reach the patient before emergency medical services (EMS) and begin life-saving actions. The FIRSST-RER study aims to evaluate whether the intervention of First Responders improves survival in patients with out-of-hospital cardiac arrest in Emilia-Romagna. This is a multicentre observational study involving approximately 5,000 adult patients who experienced cardiac arrest between 2018 and 2025 and were treated by the regional emergency system. The study compares two groups of patients: those who received help from at least one First Responder activated via the app those who did not receive First Responder intervention The main objective is to determine whether First Responders increase survival at 30 days after cardiac arrest. Additional objectives include evaluating: survival at 6 months and 1 year neurological outcomes (brain function recovery) Data for this study are collected from existing healthcare and emergency system databases, including EMS dispatch records, national health data systems, and the DAE RespondER platform. For patients who survive, follow-up information may be collected through medical records or telephone contact. Importantly, this study does not involve any experimental treatments or changes in patient care. It is based entirely on data already collected during routine emergency care, and therefore does not pose additional risks to patients. All data are handled securely and in compliance with privacy regulations. Personal identifiers are replaced with coded information (pseudonymisation), and only authorised researchers can access the data. Patients who are alive may be contacted to provide consent and additional follow-up information; participation is voluntary, and consent can be withdrawn at any time. The results of this study will provide important evidence on the effectiveness of citizen responder systems and may help guide future improvements in emergency response organisation, public health strategies, and training programmes. Ultimately, the goal is to increase survival and improve outcomes for people experiencing cardiac arrest in the community.

Who can participate

Age range

18 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: * Age ≥18 years * Confirmed out-of-hospital cardiac arrest (OHCA) * Emergency medical services activation with Advanced Life Support dispatch (Code Red Advanced Blue) * OHCA confirmed by return code 2-3-4 and/or NSIS codes (C0208 or C0205) * Event occurring between 1 January 2018 and 31 December 2025 * Activation of the regional emergency medical system (Emilia-Romagna 118 system) Exclusion Criteria: * Age \<18 years * Cardiac arrest not confirmed after EMS assessment * Cases with return code \<2 (misclassified as cardiac arrest)

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 is studying whether first responder intervention — like bystander CPR or defibrillation — improves 30-day survival after out-of-hospital cardiac arrest in the Emilia-Romagna region of Italy; given that it's not yet recruiting, is this even a realistic option for me or my family member right now, and would it require us to be located in that region?
2Since this study is listed as 'Phase NA,' which likely means it's an observational or registry-based study rather than a traditional treatment trial, can you help me understand whether participating would change the care I or my loved one actually receives, or would it only involve data collection after the fact?
3The trial measures survival at 30 days after out-of-hospital cardiac arrest — does my situation or risk profile make 30-day survival a relevant goal to plan around, and are there other outcomes like neurological recovery that I should also be asking about?
4Because out-of-hospital cardiac arrest happens suddenly and unpredictably, how would someone actually enroll in a study like this, and is there anything our family should be doing now — like CPR training or knowing where defibrillators are located nearby — that could matter regardless of this trial?
5Are there existing programs, guidelines, or standard-of-care interventions in our area that already reflect what this trial is trying to study, so that we might benefit from that knowledge without waiting for this trial to open and complete?

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

Survival at 30 Days After Out-of-Hospital Cardiac Arrest

Timeframe: 30 days after the index event

Trial details

NCT IDNCT07589504

SponsorAzienda Usl di Bologna

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

Lorenzo Gamberini, Medical Doctor

+390516478215 lorenzo.gamberini@ausl.bologna.it

View on ClinicalTrials.gov More Cardiac Arrest (CA) trials