Cardiac Arrest (CA)FIRSST-RERNCT07589504
The Impact of First Responder Intervention on Survival in Out-of-Hospital Cardiac Arrest in Emilia-Romagna Region
An observational study of Cardiac Arrest (CA), run by Azienda Usl di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest (CA)
- How many people
- 5,200 participants
- Where
- 1 siteItaly
- Study dates
- May 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- Age <18 years
- Cardiac arrest not confirmed after EMS assessment
- Cases with return code <2 (misclassified as cardiac arrest)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Carlo Alberto Pizzardi Major Hospital
Bologna, Emilia-Romagna
Lorenzo Gamberini, Medical Doctor, +390516378215, lorenzo.gamberini@ausl.bologna.it
About this study
Official title: FIRSST-RER Study: The Impact of First Responder Intervention on Survival in Out-of-Hospital Cardiac Arrest in Emilia-Romagna
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.
Read more
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.
- Conditions
- Cardiac Arrest (CA)
- Keywords
- first responder, out of hospital cardiac arrest, survival
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| First Responder Intervention | Patients with OHCA in whom at least one First Responder accepted the mission via DAE RespondER | |
| No First Responder Intervention | Patients with OHCA in whom no First Responder accepted the mission |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after the index event
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days after the index event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study startMay 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiac Arrest (CA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 5,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Responsible party
- Principal investigator, LORENZO GAMBERINI, Azienda Usl di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589504
- Sponsor's protocol ID
- 116-2026-OSS-AUSLBO
- Acronym
- FIRSST-RER
- Status last verified
- Apr 2026
- First submitted
- 10 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Marks T, Metelmann B, Gamberini L, Metelmann C, Schnaubelt S, Semeraro F, Hansen CM; European Resuscitation Guidelines 2025 Systems Saving Lives Writing Group. Smartphone-based alert of community first responders: A multinational survey to characterise contemporary systems. Resusc Plus. 2025 May 21;24:100988. doi: 10.1016/j.resplu.2025.100988. eCollection 2025 Jul.
PubMed 40524974Gamberini L, Del Giudice D, Tartaglione M, Allegri D, Coniglio C, Pastori A, Gordini G, Semeraro F; Collaborators. Logistic and cognitive-emotional barriers experienced by first responders when alarmed to get dispatched to out-of-hospital cardiac arrest events: a region-wide survey. Intern Emerg Med. 2024 Apr;19(3):813-822. doi: 10.1007/s11739-023-03487-2. Epub 2023 Dec 21.
PubMed 38123905Gamberini L, Del Giudice D, Saltalamacchia S, Taylor B, Sala I, Allegri D, Pastori A, Coniglio C, Gordini G, Semeraro F; Collaborators. Factors associated with the arrival of smartphone-activated first responders before the emergency medical services in Out-of-Hospital cardiac arrest dispatch. Resuscitation. 2023 Apr;185:109746. doi: 10.1016/j.resuscitation.2023.109746. Epub 2023 Feb 21.
PubMed 36822460Metelmann C, Metelmann B, Muller MP, Scquizzato T, Baldi E, Barry T, Bottiger BW, Busch HJ, Caputo ML, Cheskes S, Cresta R, Deakin CD, Degraeuwe E, Doshi AA, Ekkel MM, Elschenbroich D, Fredman D, Gamberini L, Ganter J, Henriksen FL, Jagtenberg C, Jonsson M, Khalemsky M, Kooy TA, Lott C, Marks T, Monsieurs KG, Moens E, Ng WM, Pooth JS, Prasse S, Salcido DD, Scapigliati A, Schittko N, Schnaubelt S, Scholz SS, Shahriari P, Snobelen P, Stieglis R, Strickmann B, Tan HL, Thies KC, Vercammen S, Wetsch WA, Greif R. Defining the terminology of first responders alerted for out-of-hospital cardiac arrest by medical dispatch centres: An international consensus study on nomenclature. Resusc Plus. 2025 Feb 20;22:100912. doi: 10.1016/j.resplu.2025.100912. eCollection 2025 Mar.
PubMed 40123987Baldi E, Wnent J, Caputo ML, Haywood KL, Lilja G, Masterson S, Nehme Z, Perkins GD, Rosell-Ortiz F, Stromsoe A, Tjelmeland IBM, Graesner JT. European Resuscitation Council Guidelines 2025 Epidemiology in Resuscitation. Resuscitation. 2025 Oct;215 Suppl 1:110733. doi: 10.1016/j.resuscitation.2025.110733.
PubMed 41117565Semeraro F, Greif R, Bottiger BW, Burkart R, Cimpoesu D, Georgiou M, Yeung J, Lippert F, S Lockey A, Olasveengen TM, Ristagno G, Schlieber J, Schnaubelt S, Scapigliati A, G Monsieurs K. European Resuscitation Council Guidelines 2021: Systems saving lives. Resuscitation. 2021 Apr;161:80-97. doi: 10.1016/j.resuscitation.2021.02.008. Epub 2021 Mar 24.
PubMed 33773834
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIRSST-RER Study: The Impact of First Responder Intervention on Survival in Out-of-Hospital Cardiac Arrest in Emilia-Romagna
- ClinicalTrials.gov ID
- NCT07589504
- Acronym / sponsor ID
- FIRSST-RER / 116-2026-OSS-AUSLBO
- Conditions
- Cardiac Arrest (CA)
- Keywords
- first responder, out of hospital cardiac arrest, survival
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,200 participants (estimated)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Study start
- May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Responder Intervention | – | –Patients with OHCA in whom at least one First Responder accepted the mission via DAE RespondER |
| No First Responder Intervention | – | –Patients with OHCA in whom no First Responder accepted the mission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Age <18 years
- Cardiac arrest not confirmed after EMS assessment
- Cases with return code <2 (misclassified as cardiac arrest)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival at 30 Days After Out-of-Hospital Cardiac Arrest
Time frame: 30 days after the index event
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.
4 secondary outcomes
Survival at 6 Months After Out-of-Hospital Cardiac Arrest
Time frame: 6 months after the index event
Survival at 1 Year After Out-of-Hospital Cardiac Arrest
Time frame: 1 year after the index event
Favourable Neurological Outcome at Follow-Up
Time frame: Up to 1 year after the index event
Survival at 30 Days According to First Responder Training Level
Time frame: 30 days after the index event
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Results publication: PubMed 40524974Marks T, Metelmann B, Gamberini L, Metelmann C, Schnaubelt S, Semeraro F, Hansen CM; European Resuscitation Guidelines 2025 Systems Saving Lives Writing Group. Smartphone-based alert of community first responders: A multinational survey to characterise contemporary systems. Resusc Plus. 2025 May 21;24:100988. doi: 10.1016/j.resplu.2025.100988. eCollection 2025 Jul.
- Results publication: PubMed 38123905Gamberini L, Del Giudice D, Tartaglione M, Allegri D, Coniglio C, Pastori A, Gordini G, Semeraro F; Collaborators. Logistic and cognitive-emotional barriers experienced by first responders when alarmed to get dispatched to out-of-hospital cardiac arrest events: a region-wide survey. Intern Emerg Med. 2024 Apr;19(3):813-822. doi: 10.1007/s11739-023-03487-2. Epub 2023 Dec 21.
- Results publication: PubMed 36822460Gamberini L, Del Giudice D, Saltalamacchia S, Taylor B, Sala I, Allegri D, Pastori A, Coniglio C, Gordini G, Semeraro F; Collaborators. Factors associated with the arrival of smartphone-activated first responders before the emergency medical services in Out-of-Hospital cardiac arrest dispatch. Resuscitation. 2023 Apr;185:109746. doi: 10.1016/j.resuscitation.2023.109746. Epub 2023 Feb 21.
- Results publication: PubMed 40123987Metelmann C, Metelmann B, Muller MP, Scquizzato T, Baldi E, Barry T, Bottiger BW, Busch HJ, Caputo ML, Cheskes S, Cresta R, Deakin CD, Degraeuwe E, Doshi AA, Ekkel MM, Elschenbroich D, Fredman D, Gamberini L, Ganter J, Henriksen FL, Jagtenberg C, Jonsson M, Khalemsky M, Kooy TA, Lott C, Marks T, Monsieurs KG, Moens E, Ng WM, Pooth JS, Prasse S, Salcido DD, Scapigliati A, Schittko N, Schnaubelt S, Scholz SS, Shahriari P, Snobelen P, Stieglis R, Strickmann B, Tan HL, Thies KC, Vercammen S, Wetsch WA, Greif R. Defining the terminology of first responders alerted for out-of-hospital cardiac arrest by medical dispatch centres: An international consensus study on nomenclature. Resusc Plus. 2025 Feb 20;22:100912. doi: 10.1016/j.resplu.2025.100912. eCollection 2025 Mar.
- Results publication: PubMed 41117565Baldi E, Wnent J, Caputo ML, Haywood KL, Lilja G, Masterson S, Nehme Z, Perkins GD, Rosell-Ortiz F, Stromsoe A, Tjelmeland IBM, Graesner JT. European Resuscitation Council Guidelines 2025 Epidemiology in Resuscitation. Resuscitation. 2025 Oct;215 Suppl 1:110733. doi: 10.1016/j.resuscitation.2025.110733.
- Results publication: PubMed 33773834Semeraro F, Greif R, Bottiger BW, Burkart R, Cimpoesu D, Georgiou M, Yeung J, Lippert F, S Lockey A, Olasveengen TM, Ristagno G, Schlieber J, Schnaubelt S, Scapigliati A, G Monsieurs K. European Resuscitation Council Guidelines 2021: Systems saving lives. Resuscitation. 2021 Apr;161:80-97. doi: 10.1016/j.resuscitation.2021.02.008. Epub 2021 Mar 24.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest (CA), run by Azienda Usl di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Gamberini, Medical Doctor (+390516478215, lorenzo.gamberini@ausl.bologna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at 30 Days After Out-of-Hospital Cardiac Arrest (time frame: 30 days after the index event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07589504, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.