NCT04993716

Brief Summary

Out-of-hospital cardiac arrest (OHCA) is a public health problem, affecting 50,000 people per year in France. Intervention time (initiation of cardiopulmonary resuscitation (CPR) and advanced CPR) are associated with a better prognosis. Despite this, the latest published data show a very low overall survival (5%). Our territory has only three centers distributed hospitals with both a 24-hour coronary angiography platform and an intensive care unit. Finally, although 60% of ACEHs receive coronary angiography in the Île de France region, it is performed on only 15% of patients in the Reims University Hospital. Therefore, it seems essential to conduct a study on the reality of the support of ACEH and to study the clinical and biological factors as well as the influence of the geographical distribution of specialized technical platforms on the prognosis of patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
294

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 18, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 4, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

2.2 years

First QC Date

June 18, 2021

Last Update Submit

July 29, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Analysis of prognostic factors associated with survival without severe neurological sequelae (CPC 1-2) at 3 months among the following variables

    3 months

  • Analysis of prognostic factors associated with survival without severe neurological sequelae (CPC 1-2) with collection of a bank of biological samples, identification of clinical factors and targeted temperature control

    12 months

Study Arms (1)

Cohort

Patient present in the SAU after an extra-hospital cardiac arrest

Other: observational

Interventions

Collect from a bank of biological samples, identification of prognostic factors associated with survival without serious neurological heavy sequelae

Cohort

Eligibility Criteria

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

Our participants must be the victim of an ACEH on the Champagne-Ardenne territory admitted living in the hospital and be over eighteen years old

You may qualify if:

  • Patient victim of ACEH in the Champagne-Ardenne region admitted living in hospital.

You may not qualify if:

  • patient under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

hospital center of Troyes

Troyes, Champagne Ardennes, 10000, France

RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Central Study Contacts

Stéphane Sanchez, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor

Study Record Dates

First Submitted

June 18, 2021

First Posted

August 6, 2021

Study Start

October 4, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 1, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations