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Trial record 1 of 1 for:    NCT03220269
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RIAC - Registro Italiano Arresti Cardiaci (Italian Registry of Cardiac Arrest) (RIAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03220269
Recruitment Status : Unknown
Verified July 2017 by Italian Resuscitation Council.
Recruitment status was:  Recruiting
First Posted : July 18, 2017
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Italian Resuscitation Council

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

Condition or disease Intervention/treatment
Out-Of-Hospital Cardiac Arrest In-hospital Cardiac Arrest Other: Out-of-hospital cardiac arrest (OHCA) Other: In-hospital cardiac arrest (IHCA)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: RIAC - Registro Italiano Arresti Cardiaci. An Observational, Prospective, Multi-centre, Study of Epidemiology, Treatment, and Outcome of Cardiac Arrest
Actual Study Start Date : October 1, 2014
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: Out-of-hospital cardiac arrest (OHCA)
Data collection

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.
Other: In-hospital cardiac arrest (IHCA)
Data collection




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 30 days survival [ Time Frame: Latest data inclusion December, 31st 2019 ]
    Status of survival after 30 days after cardiac arrest



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cardiac arrest patients
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220269


Contacts
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Contact: Federico Semeraro, MD +39 333 6592670 fsemeraro2008@gmail.com
Contact: Giuseppe Ristagno, PhD +39 329 9738490 gristag@gmail.com

Locations
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Italy
Italian Resuscitation Council Recruiting
Bologna, Italy, 40128
Contact: Federico Semeraro, MD    +39 333 6592670    fsemeraro2008@gmail.com   
Contact: Giuseppe Ristagno, PhD    +39 329 9738490    gristag@gmail.com   
Principal Investigator: Erga Cerchiari, MD         
Sub-Investigator: Anita Luciani         
Sub-Investigator: Stefano Gandolfi         
Sponsors and Collaborators
Italian Resuscitation Council
Investigators
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Principal Investigator: Erga Cerchiari, MD Department of Anesthesia and Intensive Care, Maggiore Hospital, AUSL, Bologna, Italy and Italian Resuscitation Council, Bologna, Italy
Study Director: Giuseppe Ristagno, MD, PhD IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri", Milan, Italy and Italian Resuscitation Council, Bologna, Italy
Study Director: Federico Semeraro, MD Department of Anesthesia and Intensive Care, Maggiore Hospital, AUSL, Bologna, Italy and Italian Resuscitation Council, Bologna, Italy
Principal Investigator: Giovanni Gordini, MD Department of Anesthesia and Intensive Care, Maggiore Hospital, AUSL, Bologna, Italy and Italian Resuscitation Council, Bologna, Italy
Additional Information:
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Responsible Party: Italian Resuscitation Council
ClinicalTrials.gov Identifier: NCT03220269    
Other Study ID Numbers: RIAC
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Italian Resuscitation Council:
Utstein
Resuscitation
Epidemiology
Emergency medicine
Resuscitation Registry
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases