Outcome of Cardiac Arrest Survivors | NCT02494414

Studies
Outcome of Cardiac Arrest Survivors

NCT02494414

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Jul 1, 2026Actual

Enrollment

601Actual

Phase

Not provided

Conditions

Cardiac Arrest Survivors

Interventions

Long-term follow-up

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

ID	Type	Description	Link
AOR12068	Other Identifier	AOR

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 24, 2015Actual

Primary Completion Date

Jan 22, 2021Actual

Completion Date

Jan 22, 2021Actual

First Submitted Date

Apr 20, 2015

First Submission Date that Met QC Criteria

Jul 7, 2015

First Posted Date

Jul 10, 2015Estimated

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

Jun 29, 2026

Last Update Posted Date

Jul 1, 2026Actual

Name	Class
URC-CIC Paris Descartes Necker Cochin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

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.

Detailed Description

The collection of clinical and biological data of patients who experienced cardiac arrest and survive from hospital, including a regular follow-up with qualitative data (functional, neurological and quality of life) may provide important benchmark on the evolution of these patients and on the impact of acute interventions (such as cardio-pulmonary resuscitation, defibrillation, emergent coronary revascularization, neuroprotective treatments).

Using a large identified cohort of survivors of cardiac arrest, we aim to describe the qualitative long-term prognosis of these cardiac arrest patients (functional, neurological and quality of life status). Secondarily, we intend to identify the long-term prognostic factors, and particularly the role of early interventions, using a long-term and qualitative combined endpoint (vital status, functional scales, SF36).

This project is observational and will include all patients over 18 admitted alive after non-traumatic cardiac arrest in the area of Ile-de-France (France), whatever the cause of the cardiac arrest. Patients or their proxies, refusing their participation, will not be included.

We will collect all pre- and in-hospital information related to the event and performs prospectively interviews at 3 months and every year anniversary. The questionnaire will include vital status, cardiovascular events, medication and a complete qualitative report (SF36, ADL scale, OPC, CPC, social-professional activities).

This project will provide important data over time on the evolution of these patients. Findings will help in measuring the role of different strategies on long-term prognosis and consequently improve the overall management of cardiac arrest.

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

Retention

Enrollment

601Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
French prospective cohort of cardiac arrest survivors		Outcome of cardiac arrest survivors: prospective cohort of Ile-de-France	Other: Long-term follow-up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Long-term follow-up	Other	Vital and neurological follow-up	French prospective cohort of cardiac arrest survivors

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cerebral Performance Categories Scale	Combined vital and neurological status	at last follow-up (48 months max)

Secondary Outcomes

Measure	Description	Time Frame
SF-36 (Short-Form General Health Survey)	Quality of life	at last follow-up (48 months max)
Overall Performance Categories (OPC)		at last follow-up (48 months max)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Philippe Empana, MD	INSERM U970 Centre de Recherche Cardiovasculaire de Paris Equipe 4, Epidémiologie Cardiovasculaire et Mort Subite	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
INSERM U970 Centre de Recherche Cardiovasculaire de Paris Equipe 4, Epidémiologie Cardiovasculaire et Mort Subite		Paris		75000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41953986	Result	Dumas F, Bougouin W, Perier MC, Marin N, Goulenok C, Vieillard-Baron A, Diehl JL, Legriel S, Deye N, Cronier P, Ricome S, Chemouni F, Mekontso-Dessap A, Champigneulle B, Combes A, Demoule A, Thuong M, Sonneville R, Contou D, Outin H, Lamhaut L, Chelly J, Beganton F, Marijon E, Geri G, Jouven X, Empana JP, Cariou A. Long-Term Neurological Outcome of Out-of-Hospital Cardiac Arrest Survivors and Associated Factors: Results of the DESAC Study, a French Multicentric Prospective Cohort. Circ Popul Health Outcomes. 2026 May;19(5):e012269. doi: 10.1161/CIRCOUTCOMES.125.012269. Epub 2026 Apr 9.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases