Out-Of-Hospital Cardiac ArrestLombardia CAReNCT03197142
Cardiac Arrest Registry of the Lombardia Region (Lombardia CARe)
An observational study of Out-Of-Hospital Cardiac Arrest, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 21 sites in Italy.
Trial summary
The registry enroll all the patients who suffered an out-of-hospital cardiac arrest in the Lombardia Region with a follow-up up to ten years after the event. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- How many people
- 15,000 participants
- Where
- 21 sitesItaly
- Study dates
- 1 Oct 2014to 1 Oct 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients who suffered an out-of-hospital cardiac arrest of any etiology in the Lombardia Region
Who may be able to join
- Out-of-hospital cardiac arrest of any etiology in the Lombardia Region
Who cannot join
- In-hospital cardiac arrest
Trial locations and contacts
21 sites in 1 country.
Simone Savastano, MD contact
Enrico Baldi, MD contact
21 sites in 1 country
Italy21 sites, 21 recruiting
- Recruiting
AAT Brescia
Brescia
Marco Botteri
- Recruiting
Fondazione Poliambulanza di Brescia
Brescia
Diego Maffeo
- Recruiting
Spedali Civili di Brescia
Brescia
Daniele Ghiraldin
- Recruiting
Ospedale di Busto Arsizio, Gallarate
Busto Arsizio
Ivan Caico
- Recruiting
Ospedale Mater Domini di Castellanza
Castellanza
Cecilia Fantoni
- Recruiting
AAT Como
Como
Marco Paiella
- Recruiting
Ospedale Sant'Anna di Como,Ospedale Sant'Antonio Abate di Cantù e Ospedale Erba-Renaldi di Menaggio
Como
marta Ruffinazzi
- Recruiting
Azienda Socio Sanitaria Territoriale di Crema
Crema, Cremona, 26013
Cinzia Dossena
- Recruiting
Azienda Socio Sanitaria Territoriale di Cremona
Cremona, 26100
Luigi Moschini
Laura Zanotti
- Recruiting
AAT 118 - Cremona, AREU Lombardia
Cremona
Ugo Rizzi
Simone Ruggeri, RN
- Recruiting
Ospedale di Legnano
Legnano
Claudio Vimercati
- Recruiting
Azienda Socio Sanitaria Territoriale di Lodi
Lodi, 26900
Irene Raimondi Cominesi
- Recruiting
AAT 118 - Lodi, AREU Lombardia
Lodi
Giuseppe S Bergamini, MD
Francesca Reali
- Recruiting
Azienda Socio Sanitaria Territoriale di Mantova
Mantua, Mantova, 46100
Cristian Fava
Giovanni Buetto
- Recruiting
AAT 118 - Mantova, AREU Lombardia
Mantua
Pierpaolo Parogni, MD
Fabio Facchin, RN
- Recruiting
AAT 118 - Pavia, AREU Lombardia
Pavia
Alessandra Palo, MD
Enrico Contri, MD
- Recruiting
IRCCS Policlinico San Matteo
Pavia
Simone Savastano, MD, s.savastano@smatteo.pv.it
Enrico Baldi, MD, enrico.baldi88@gmail.com
- Recruiting
AAT Varese
Varese
Sabina Campi
- Recruiting
Ospedale di Angera, Cittiglio, Varese Circolo, Luino, Tradate
Varese
Roberto De Ponti
- Recruiting
Ospedale Civile di Vigevano, Azienda Socio-Sanitaria Territoriale di Pavia
Vigevano
Roberta Bertona, MD
- Recruiting
Ospedale Civile di Voghera, Azienda Socio-Sanitaria Territoriale di Pavia
Voghera
Fabrizio Giofrè, MD
About this study
The registry enroll all the patients who suffered an out-of-hospital cardiac arrest in the Lombardia Region with a follow-up up to ten years after the event.
Read the detailed description
The registry is an observational study which enroll all the patients who suffered an out-of-hospital cardiac arrest of any etiology in the Lombardia Region The follow-up of the patients is at 1 month after the event, 6 month and every year up to five years after the event.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- cardiac arrest, resuscitation, Out-Of-Hospital Cardiac Arrest, CPR
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Heart 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 |
|---|---|---|
| Out-of-hospital cardiac arrest | All the patients who suffered an out-of-hospital cardiac arrest in the Lombardia Region |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival with good neurological outcome for OHCA patients of any etiology
Survival with Cerebral Performance Category of 1 or 2
Measured: From cardiac arrest date up to 10 years or up to death, whichever come first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start1 Oct 2014
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Regionale Emergenza Urgenza - AREU Lombardia, Azienda Socio-Sanitaria Territoriale di Pavia, Azienda Socio Sanitaria Territoriale di Lodi, Azienda Socio-Sanitaria Territoriale di Crema, Azienda Socio Sanitaria Territoriale di Mantova, Azienda Socio Sanitaria Territoriale di Cremona, Azienda Socio-Sanitaria Territoriale Sette Laghi, Azienda Socio Sanitaria Territoriale della Valle Olona, Azienda Socio-Sanitaria Territoriale Lariana, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, ASST FRANCIACORTA, Azienda Socio Sanitaria Territoriale del Garda, ASST Valcamonica
- Responsible party
- Principal investigator, Simone Savastano, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197142
- Sponsor's protocol ID
- Lombardia CARe
- Acronym
- Lombardia CARe
- Status last verified
- Feb 2023
- First submitted
- 17 Jun 2017
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Arrest Registry of the Lombardia Region (Lombardia CARe)
- ClinicalTrials.gov ID
- NCT03197142
- Acronym / sponsor ID
- Lombardia CARe / Lombardia CARe
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- cardiac arrest, resuscitation, Out-Of-Hospital Cardiac Arrest, CPR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Collaborators
- Azienda Regionale Emergenza Urgenza - AREU Lombardia, Azienda Socio-Sanitaria Territoriale di Pavia, Azienda Socio Sanitaria Territoriale di Lodi, Azienda Socio-Sanitaria Territoriale di Crema, Azienda Socio Sanitaria Territoriale di Mantova, Azienda Socio Sanitaria Territoriale di Cremona, Azienda Socio-Sanitaria Territoriale Sette Laghi, Azienda Socio Sanitaria Territoriale della Valle Olona, Azienda Socio-Sanitaria Territoriale Lariana, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, ASST FRANCIACORTA, Azienda Socio Sanitaria Territoriale del Garda, ASST Valcamonica
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 23 Jun 2017 (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.
The registry enroll all the patients who suffered an out-of-hospital cardiac arrest in the Lombardia Region with a follow-up up to ten years after the event.
Detailed description
The registry is an observational study which enroll all the patients who suffered an out-of-hospital cardiac arrest of any etiology in the Lombardia Region The follow-up of the patients is at 1 month after the event, 6 month and every year up to five years after the event.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Out-of-hospital cardiac arrest | – | –All the patients who suffered an out-of-hospital cardiac arrest in the Lombardia Region |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients who suffered an out-of-hospital cardiac arrest of any etiology in the Lombardia Region
Key inclusion criteria (1 listed)
- Out-of-hospital cardiac arrest of any etiology in the Lombardia Region
Key exclusion criteria (1 listed)
- In-hospital 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 with good neurological outcome for OHCA patients of any etiology
Time frame: From cardiac arrest date up to 10 years or up to death, whichever come first
Survival with Cerebral Performance Category of 1 or 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Out-Of-Hospital Cardiac Arrest
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CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
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The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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Compression-Only Versus Standard Basic Life Support Training in Nursing Students
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Cardiac Arrest, Out-Of-Hospital
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. This study is not recruiting at the moment.
Simone Savastano, MD contact
Enrico Baldi, MD contact
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-Of-Hospital Cardiac Arrest, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 21 sites 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simone Savastano, MD (s.savastano@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival with good neurological outcome for OHCA patients of any etiology (time frame: From cardiac arrest date up to 10 years or up to death, whichever come first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2023.