NCT02494414

Brief Summary

Early prognosis of cardiac arrest - nearly 40000 new cases per year in France - has been extensively studied, highlighting a poor outcome (less than 8% at hospital discharge). However, little is known on mid and long-term prognostic factors and how these patients do survive from the event. Using a regional cohort, the aim of the study is to describe long-term survival rate of cardiac arrest survivors, and to assess the influence of treatment strategies on survival and functional outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
601

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 20, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

July 24, 2015

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2021

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

5.5 years

First QC Date

April 20, 2015

Last Update Submit

March 26, 2026

Conditions

Cardiac Arrest Survivors

Keywords

Cardiac arrestoutcomeneurological status

Outcome Measures

Primary Outcomes (1)

  • Cerebral Performance Categories Scale

    Combined vital and neurological status

    at last follow-up (48 months max)

Secondary Outcomes (5)

  • SF-36 (Short-Form General Health Survey)

    at last follow-up (48 months max)

  • Overall Performance Categories (OPC)

    at last follow-up (48 months max)

  • Activities of Daily Living (ADL) scale

    at last follow-up (48 months max)

  • New cardiovascular events

    at last follow-up (48 months max)

  • New York Heart Association (NYHA) status

    at last follow-up (48 months max)

Study Arms (1)

French prospective cohort of cardiac arrest survivors

Outcome of cardiac arrest survivors: prospective cohort of Ile-de-France

Other: Long-term follow-up

Interventions

Long-term follow-upOTHER

Vital and neurological follow-up

French prospective cohort of cardiac arrest survivors

Eligibility Criteria

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

Patients will be prospectively included if they are discharged alive from intensive care after being resuscitated from a cardiac arrest

You may qualify if:

  • Patients alive after resuscitation from a out-of-hospital cardiac arrest
  • All causes for cardiac arrest
  • Age above 18
  • Informed consent from the patient or next of kin

You may not qualify if:

  • Impossibility for communication after hospital discharge, whatever the cause (language, residence…)
  • Follow-up refusal from the patient or next of kin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INSERM U970 Centre de Recherche Cardiovasculaire de Paris Equipe 4, Epidémiologie Cardiovasculaire et Mort Subite

Paris, 75000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jean-Philippe Empana, MD

    INSERM U970 Centre de Recherche Cardiovasculaire de Paris Equipe 4, Epidémiologie Cardiovasculaire et Mort Subite

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

April 20, 2015

First Posted

July 10, 2015

Study Start

July 24, 2015

Primary Completion

January 22, 2021

Study Completion

January 22, 2021

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

FR(1)