NCT06569134

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 23, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2025

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

August 8, 2024

Last Update Submit

August 21, 2024

Conditions

Cardiac ArrestNeurologic DysfunctionCognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Cognitive Outcome

    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 Outcomes (3)

  • Death OoH

    Before hospital arrival

  • Death ICU

    During ICU stay

  • Death at Day 28

    28 days after cardiac arrest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Cardiac arrest requiring cardiopulmonary resuscitation

You may not qualify if:

  • Death before cardiopulmonary resuscitation
  • Pediatric Patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Brest

Brest, 29609, France

Location

CH des pays de Morlaix

Morlaix, 29600, France

Location

MeSH Terms

Conditions

Heart ArrestNeurologic ManifestationsCognitive Dysfunction

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 23, 2024

Study Start

July 24, 2022

Primary Completion

January 24, 2023

Study Completion

January 24, 2025

Last Updated

August 23, 2024

Record last verified: 2024-08

Locations

FR(2)