Out-Of-Hospital Cardiac ArrestRIACNCT03220269
RIAC - Registro Italiano Arresti Cardiaci (Italian Registry of Cardiac Arrest)
An observational study of Out-Of-Hospital Cardiac Arrest and In-hospital Cardiac Arrest, run by Italian Resuscitation Council at 1 site in Italy.
Trial summary
RIAC - An Observational, Prospective, Multi-centre, Study of Epidemiology, Treatment, and Outcome of Cardiac Arrest in Italy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest, In-hospital Cardiac Arrest
- What is being tested?
- Out-of-hospital cardiac arrest (OHCA) and In-hospital cardiac arrest (IHCA)
- How many people
- 8,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2014to 30 Dec 2019
- How long will I take part?
- 6 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiac arrest patients
Who may be able to join
- All patients aged ≥ 18 years old who undergo an out-of-hospital cardiac or an in-hospital cardiac arrest.
Who cannot join
- All patients without a cardiac arrest diagnosis
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Italian Resuscitation Council
Bologna, 40128
Federico Semeraro, MD, +39 333 6592670, fsemeraro2008@gmail.com
Giuseppe Ristagno, PhD, +39 329 9738490, gristag@gmail.com
About this study
Official title: RIAC - Registro Italiano Arresti Cardiaci. An Observational, Prospective, Multi-centre, Study of Epidemiology, Treatment, and Outcome of Cardiac Arrest
RIAC - An Observational, Prospective, Multi-centre, Study of Epidemiology, Treatment, and Outcome of Cardiac Arrest in Italy.
Read the detailed description
The Italian Registry of Cardiac Arrest (RIAC) has been established in Italy by the Italian Resuscitation Council (IRC). It is a free web registry based on Utstein style data collection for all EMS and ICU departments that want to participate to this study.
This research project will include all events that occur between 00.00 on October 1st, 2014 and 23:59 on September 30th, 2019. The RIAC registry allows to follow and collect data from consecutive patients with cardiac arrest.
The expected outcomes of RIAC are:
- The implementation of an Italian registry of cardiac arrest that allows the prospective data collection.
- The study of the incidence of out-of-hospital cardiac arrest (OHCA) among the general population and related outcomes (hospital admission and long-term outcomes). An observational, prospective, multi-centre study on patients assisted by EMS which collect data on cardiac arrest using RIAC.
- The study of the incidence of in-hospital cardiac arrest (IHCA) among hospitalized patients, the quality level of treatments during the hospitalization period and the long-term outcomes. An observational, prospective, multi-centre study on hospitalized patients in hospitals which can efficaciously respond to an in-hospital emergency and collect data on cardiac arrest using RIAC.
- The study of the quality of post-resuscitation treatments for patients who suffered a cardiac arrest (OHCA-IHCA) admitted to ICUs. An observational, prospective, multi-centre study on patients admitted to ICUs which collect data on cardiac arrest using RIAC.
- A national database of cardiac arrest that will enable future participations to European projects, such as EuReCa "An international, prospective, multi-centre, three-month survey of epidemiology, treatment and outcome of patients suffering an out-of-hospital cardiac arrest in Europe".
For the perspective incidence study of IHCA, OHCA and the quality of post-resuscitation treatments, all cases with a cardiac arrest diagnosis aged ≥ 18 years old will be included. All patients without a cardiac arrest diagnosis will be excluded.
The main outcomes for the study population are listed for each subgroup.
Out-of-hospital Cardiac arrest:
- Estimate the incidence of cardiac arrest among the representative general population.
- Describe the implemented interventions outcomes.
- Define the cohort of out-of-hospital cardiac arrest arrived alive at the emergency department and describe the in-hospital pathway.
- Evaluate the quality of long-term outcomes (30-days survival; survival to discharge) of patients discharged alive.
In-hospital cardiac arrest:
- It is expected to enlist 10-20 patients per year per each participating hospital.
Quality of post-resuscitation treatments in ICUs:
- It is expected to enlist a number of patients which is calculated as the number of survived patients to IHCA and hospitalized in ICU plus the number of patients with OHCA arrived alive at emergency unit and hospitalized in ICU.
Statistical data analysis will be based on three main objectives. The incidence of cardiac arrest for OHCA will be evaluated as the ratio between the number of confirmed OHCA occurred during the whole study and the referring population.
The incidence of cardiac arrest for IHCA will be calculated using as denominator, the population at risk (ordinary recovery other than day hospital and day surgery). For the evaluation study of the quality level of treatments in Intensive Care Units, a multivariate analysis will be performed to assess the connection between outcomes and treatments. In particular, the relation between injury variable (duration of no-flow time and CPR defined as flow <20%), treatments (temperature, glycaemia, convulsions, hypothermia, serum potassium levels, acidosis during the first 72 hours, etc.) and outcome to discharge defined using CPC classification, will be evaluated.
The proportion of patients with CPC 3 and CPC 4 on the amount of IHCA an OHCA cardiac arrests, will be evaluated.
All participanting EMS/hospitals able to provide at least the core data, need to fill out a letter of intent to participate in this study and must provide an ethical approval from the local Ethical Committee.
- Being tested
- Out-of-hospital cardiac arrest (OHCA), In-hospital cardiac arrest (IHCA)
- Keywords
- Utstein, Resuscitation, Epidemiology, Emergency medicine, Resuscitation Registry
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Out-of-hospital cardiac arrest (OHCA)Other
Data collection
In-hospital cardiac arrest (IHCA)Other
Data collection
| Study group | Role | What they receive |
|---|---|---|
| Out-of-hospital cardiac arrest (OHCA) | An OHCA is defined as cessation of cardiac mechanical activity that occurs outside of the hospital setting and is confirmed by the absence of signs of circulation. Receives: Other: Out-of-hospital cardiac arrest (OHCA) | |
| In-hospital cardiac arrest (IHCA) | An IHCA is defined as cessation of cardiac mechanical activity that occurs inside of the hospital setting and is confirmed by the absence of signs of circulation. Receives: Other: In-hospital cardiac arrest (IHCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence for OHCA and IHCA
The aim of the RIAC study is to determine the number of cardiac arrest for out-of hospital cardiac arrest and for in-hospital cardiac arrest events.
Measured: Latest data inclusion December, 31st 2019
Outcome for OHCA and IHCA
The aim is to determine the percentage of Return of Spontaneous Circulation (ROSC) and six months survival with good neurological performance (assessed with Cerebral Performance Category scale) with a CPC score between 1-2, after 6 months of the cardiac arrest.
Measured: Latest data inclusion March 31st, 2020
Secondary outcomes (1)
30 days survival
Status of survival after 30 days after cardiac arrest
Measured: Latest data inclusion December, 31st 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start1 Oct 2014
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (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.
- 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
- Prospective
- Enrolment
- 8,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Italian Resuscitation Council
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erga Cerchiari, MD, Principal investigator, Department of Anesthesia and Intensive Care, Maggiore Hospital, AUSL, Bologna, Italy and Italian Resuscitation Council, Bologna, ItalyGiuseppe Ristagno, MD, PhD, Study director, IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri", Milan, Italy and Italian Resuscitation Council, Bologna, ItalyFederico Semeraro, MD, Study director, Department of Anesthesia and Intensive Care, Maggiore Hospital, AUSL, Bologna, Italy and Italian Resuscitation Council, Bologna, ItalyGiovanni Gordini, MD, Principal investigator, Department of Anesthesia and Intensive Care, Maggiore Hospital, AUSL, Bologna, Italy and Italian Resuscitation Council, Bologna, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220269
- Sponsor's protocol ID
- RIAC
- Acronym
- RIAC
- Status last verified
- Jul 2017
- First submitted
- 22 Jun 2017
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available for inclusion/participation in European cardiac arrest registries from European scientific societies or consortium, i.e. EuReCa registry from European Resuscitation Council. Data sets to be shared will be selected based on data required from the European registry. Data shared will be anonimized with no possibility to retrieve personal patient information. Data sharing will be approved by the RIAC Steering Committe and data will be transfered to the other Registry in a secure way under the direction of the Scientific Committee
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RIAC - Registro Italiano Arresti Cardiaci. An Observational, Prospective, Multi-centre, Study of Epidemiology, Treatment, and Outcome of Cardiac Arrest
- ClinicalTrials.gov ID
- NCT03220269
- Acronym / sponsor ID
- RIAC / RIAC
- Keywords
- Utstein, Resuscitation, Epidemiology, Emergency medicine, Resuscitation Registry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Italian Resuscitation CouncilUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 18 Jul 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.
RIAC - An Observational, Prospective, Multi-centre, Study of Epidemiology, Treatment, and Outcome of Cardiac Arrest in Italy.
Detailed description
The Italian Registry of Cardiac Arrest (RIAC) has been established in Italy by the Italian Resuscitation Council (IRC). It is a free web registry based on Utstein style data collection for all EMS and ICU departments that want to participate to this study.
This research project will include all events that occur between 00.00 on October 1st, 2014 and 23:59 on September 30th, 2019. The RIAC registry allows to follow and collect data from consecutive patients with cardiac arrest.
The expected outcomes of RIAC are:
- The implementation of an Italian registry of cardiac arrest that allows the prospective data collection.
- The study of the incidence of out-of-hospital cardiac arrest (OHCA) among the general population and related outcomes (hospital admission and long-term outcomes). An observational, prospective, multi-centre study on patients assisted by EMS which collect data on cardiac arrest using RIAC.
- The study of the incidence of in-hospital cardiac arrest (IHCA) among hospitalized patients, the quality level of treatments during the hospitalization period and the long-term outcomes. An observational, prospective, multi-centre study on hospitalized patients in hospitals which can efficaciously respond to an in-hospital emergency and collect data on cardiac arrest using RIAC.
- The study of the quality of post-resuscitation treatments for patients who suffered a cardiac arrest (OHCA-IHCA) admitted to ICUs. An observational, prospective, multi-centre study on patients admitted to ICUs which collect data on cardiac arrest using RIAC.
- A national database of cardiac arrest that will enable future participations to European projects, such as EuReCa "An international, prospective, multi-centre, three-month survey of epidemiology, treatment and outcome of patients suffering an out-of-hospital cardiac arrest in Europe".
For the perspective incidence study of IHCA, OHCA and the quality of post-resuscitation treatments, all cases with a cardiac arrest diagnosis aged ≥ 18 years old will be included. All patients without a cardiac arrest diagnosis will be excluded.
The main outcomes for the study population are listed for each subgroup.
Out-of-hospital Cardiac arrest:
- Estimate the incidence of cardiac arrest among the representative general population.
- Describe the implemented interventions outcomes.
- Define the cohort of out-of-hospital cardiac arrest arrived alive at the emergency department and describe the in-hospital pathway.
- Evaluate the quality of long-term outcomes (30-days survival; survival to discharge) of patients discharged alive.
In-hospital cardiac arrest:
- It is expected to enlist 10-20 patients per year per each participating hospital.
Quality of post-resuscitation treatments in ICUs:
- It is expected to enlist a number of patients which is calculated as the number of survived patients to IHCA and hospitalized in ICU plus the number of patients with OHCA arrived alive at emergency unit and hospitalized in ICU.
Statistical data analysis will be based on three main objectives. The incidence of cardiac arrest for OHCA will be evaluated as the ratio between the number of confirmed OHCA occurred during the whole study and the referring population.
The incidence of cardiac arrest for IHCA will be calculated using as denominator, the population at risk (ordinary recovery other than day hospital and day surgery). For the evaluation study of the quality level of treatments in Intensive Care Units, a multivariate analysis will be performed to assess the connection between outcomes and treatments. In particular, the relation between injury variable (duration of no-flow time and CPR defined as flow <20%), treatments (temperature, glycaemia, convulsions, hypothermia, serum potassium levels, acidosis during the first 72 hours, etc.) and outcome to discharge defined using CPC classification, will be evaluated.
The proportion of patients with CPC 3 and CPC 4 on the amount of IHCA an OHCA cardiac arrests, will be evaluated.
All participanting EMS/hospitals able to provide at least the core data, need to fill out a letter of intent to participate in this study and must provide an ethical approval from the local Ethical Committee.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Out-of-hospital cardiac arrest (OHCA) | – | Other: Out-of-hospital cardiac arrest (OHCA)An OHCA is defined as cessation of cardiac mechanical activity that occurs outside of the hospital setting and is confirmed by the absence of signs of circulation. |
| In-hospital cardiac arrest (IHCA) | – | Other: In-hospital cardiac arrest (IHCA)An IHCA is defined as cessation of cardiac mechanical activity that occurs inside of the hospital setting and is confirmed by the absence of signs of circulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac arrest patients
Key inclusion criteria (1 listed)
- All patients aged ≥ 18 years old who undergo an out-of-hospital cardiac or an in-hospital cardiac arrest.
Key exclusion criteria (1 listed)
- All patients without a cardiac arrest diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Out-of-hospital cardiac arrest (OHCA)Data collection | Other | Out-of-hospital cardiac arrest (OHCA) |
| In-hospital cardiac arrest (IHCA)Data collection | Other | In-hospital cardiac arrest (IHCA) |
Primary outcome
Incidence for OHCA and IHCA
Time frame: Latest data inclusion December, 31st 2019
The aim of the RIAC study is to determine the number of cardiac arrest for out-of hospital cardiac arrest and for in-hospital cardiac arrest events.
Outcome for OHCA and IHCA
Time frame: Latest data inclusion March 31st, 2020
The aim is to determine the percentage of Return of Spontaneous Circulation (ROSC) and six months survival with good neurological performance (assessed with Cerebral Performance Category scale) with a CPC score between 1-2, after 6 months of the cardiac arrest.
1 secondary outcome
30 days survival
Time frame: Latest data inclusion December, 31st 2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- RIAC official websiteLink provided by the sponsor.
- IRC official websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be available for inclusion/participation in European cardiac arrest registries from European scientific societies or consortium, i.e. EuReCa registry from European Resuscitation Council. Data sets to be shared will be selected based on data required from the European registry. Data shared will be anonimized with no possibility to retrieve personal patient information. Data sharing will be approved by the RIAC Steering Committe and data will be transfered to the other Registry in a secure way under the direction of the Scientific Committee
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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. This study is not recruiting at the moment.
Erga Cerchiari, MD principal investigator
Department of Anesthesia and Intensive Care, Maggiore Hospital, AUSL, Bologna, Italy and Italian Resuscitation Council, Bologna, Italy
Giuseppe Ristagno, MD, PhD study director
IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri", Milan, Italy and Italian Resuscitation Council, Bologna, Italy
Federico Semeraro, MD study director
Department of Anesthesia and Intensive Care, Maggiore Hospital, AUSL, Bologna, Italy and Italian Resuscitation Council, Bologna, Italy
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 Out-Of-Hospital Cardiac Arrest and In-hospital Cardiac Arrest, run by Italian Resuscitation Council 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 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 18 Jul 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federico Semeraro, MD (+39 333 6592670, fsemeraro2008@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence for OHCA and IHCA (time frame: Latest data inclusion December, 31st 2019). The study lists 2 primary outcomes in all. 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 18 Jul 2017.