Identification of Neuroprognostic Factors for Out-of-hosp... | NCT06569134

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

NCT06569134

Sponsor

University Hospital, Brest

Status

Active, not recruiting

Last Update Posted

Aug 23, 2024Actual

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Cardiac Arrest
Neurologic Dysfunction
Cognitive Impairment

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 24, 2022Actual

Primary Completion Date

Jan 24, 2023Actual

Completion Date

Jan 24, 2025Estimated

First Submitted Date

Aug 8, 2024

First Submission Date that Met QC Criteria

Aug 21, 2024

First Posted Date

Aug 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2024

Last Update Posted Date

Aug 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Death OoH	Death after resuscitation during the prehospital care phase	Before hospital arrival
Death ICU	Death within the ICU care

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cardiac arrest requiring cardiopulmonary resuscitation

Exclusion Criteria:

Death before cardiopulmonary resuscitation
Pediatric Patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Brest		Brest		29609	France
CH des pays de Morlaix

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest
D009461	Neurologic Manifestations
D060825	Cognitive Dysfunction

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided