Identification of Neuroprognostic Factors for Out-of-hospital Cardiopulmonary Arrest (MIRA29) (MIRA29)

August 21, 2024 updated by: University Hospital, Brest

Identification of Neuroprognostic Factors for Out-of-hospital Cardiopulmonary Arrest in the North Finistère Population: Derivation and Validation of a Predictive Score

From the informatized prehospital care registry, data will be collected anonymously for all patients' requiring cardiopulmonary resuscitation for an out-of-hospital cardiac arrest within the Norther Finistere sanitary region.

First step of the model derivation will consist in multivariate analysis to extract the most pertinent variates associated with neurological outcome (evaluated using the CPC Score); Second step will consist in the use of artificial intelligence and machine-learning to derive the most discriminant score.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • Chu de Brest
      • Morlaix, France, 29600
        • CH des Pays de Morlaix

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients presenting a cardiac arrest requiring cardiopulmonary resuscitation, taken in charge by the Northern Finistere Prehospital Care System, will be included Datafiles will be individually revised

Description

Inclusion Criteria:

  • Cardiac arrest requiring cardiopulmonary resuscitation

Exclusion Criteria:

  • Death before cardiopulmonary resuscitation
  • Pediatric Patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Outcome
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
It will be evaluated at the end of the ICU stay using the CPC score; a CPC score equal or below 2 will be considered as a good outcome, while a CPC > 2 will be considered as a bad outcome
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death OoH
Time Frame: Before hospital arrival
Death after resuscitation during the prehospital care phase
Before hospital arrival
Death ICU
Time Frame: During ICU stay
Death within the ICU care
During ICU stay
Death at Day 28
Time Frame: 28 days after cardiac arrest
Death at Day 28, before or after hospital discharge
28 days after cardiac arrest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2022

Primary Completion (Actual)

January 24, 2023

Study Completion (Estimated)

January 24, 2025

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 21, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

August 23, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC22.0114 - MIRA29

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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