An observational study in Cardiac Arrest (CA), sponsored by Azienda Usl di Bologna. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by Azienda Usl di Bologna · Observational
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.
Adult patients (≥18 years) with confirmed out-of-hospital cardiac arrest managed by the regional emergency medical services (118 system) in Emilia-Romagna between 1 January 2018 and 31 December 2025. Patients are identified through EMS dispatch databases and national health information systems and include cases in which a First Responder was activated via the DAE RespondER system. The study population reflects a real-world, unselected cohort of OHCA patients treated within an integrated regional emergency care system.
Exclusion Criteria:
Patients with OHCA in whom at least one First Responder accepted the mission via DAE RespondER
Patients with OHCA in whom no First Responder accepted the mission
Survival at 30 Days After Out-of-Hospital Cardiac Arrest
All-cause survival at 30 days after the index out-of-hospital cardiac arrest event, assessed using regional health administrative databases and follow-up data.
Time frame: 30 days after the index event
Survival at 6 Months After Out-of-Hospital Cardiac Arrest
All-cause survival at 6 months after the index out-of-hospital cardiac arrest event, assessed using regional health administrative databases and follow-up data.
Time frame: 6 months after the index event
Survival at 1 Year After Out-of-Hospital Cardiac Arrest
All-cause survival at 1 year after the index out-of-hospital cardiac arrest event, assessed using regional health administrative databases and follow-up data.
Time frame: 1 year after the index event
Favourable Neurological Outcome at Follow-Up
Neurological outcome assessed at the longest available follow-up using the Cerebral Performance Category (CPC) scale. Favourable outcome is defined as CPC 1-2, and unfavourable outcome as CPC 3-5.
Time frame: Up to 1 year after the index event
Survival at 30 Days According to First Responder Training Level
Comparison of 30-day survival between patients receiving intervention from trained First Responders (BLS/ALS certified) and those receiving intervention from untrained First Responders.
Time frame: 30 days after the index event
Plan to share: Yes — Individual participant data (IPD) that underlie the results reported in this study, after de-identification, will be made available to researchers upon reasonable request. Data will be available beginning 6 months and ending 5 years following publication of the study results. Researchers who provide a methodologically sound proposal will be eligible to access the data for purposes of achieving the aims of the approved proposal. Proposals should be directed to the corresponding investigator. Data will be shared following approval by the study steering committee and in compliance with applicable data protection regulations (GDPR). Data will be provided in a de-identified format, and a data sharing agreement will be required.
Supporting information: Study protocol, Sap
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Azienda Usl di Bologna