RIAC - Registro Italiano Arresti Cardiaci (Italian Registry of Cardiac Arrest)

Out-Of-Hospital Cardiac Arrest Clinical Trial

— RIAC  

Official title:

RIAC - Registro Italiano Arresti Cardiaci. An Observational, Prospective, Multi-centre, Study of Epidemiology, Treatment, and Outcome of Cardiac Arrest

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03220269
• Other study ID #: RIAC
• Status: Recruiting
• Phase: N/A
• First received: June 22, 2017
• Last updated: July 13, 2017
• Start date: October 1, 2014
• Est. completion date: December 30, 2019

Study information

• Verified date: July 2017
• Source: Italian Resuscitation Council
• Contact: Federico Semeraro, MD
• Phone: +39 333 6592670
• Email: fsemeraro2008[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

RIAC - An Observational, Prospective, Multi-centre, Study of Epidemiology, Treatment, and Outcome of Cardiac Arrest in Italy.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All patients aged = 18 years old who undergo an out-of-hospital cardiac or an in-hospital cardiac arrest.

Exclusion Criteria:

All patients without a cardiac arrest diagnosis

Related Conditions & MeSH terms

• Heart Arrest
• In-hospital Cardiac Arrest
• Out-Of-Hospital Cardiac Arrest

Intervention

Other:
• Out-of-hospital cardiac arrest (OHCA)
Data collection
• In-hospital cardiac arrest (IHCA)
Data collection

Locations

Country	Name	City	State
Italy	Italian Resuscitation Council	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Italian Resuscitation Council

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Latest data inclusion December, 31st 2019
Primary	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.	Latest data inclusion March 31st, 2020
Secondary	30 days survival	Status of survival after 30 days after cardiac arrest	Latest data inclusion December, 31st 2019

External Links

•   IRC official website
•   RIAC official website