Outcome of Cardiac Arrest Survivors (DESAC)

Outcome of Cardiac Arrest Survivors: Prospective Cohort of Ile-de-France

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest Survivors
• Intervention / Treatment: Other: Long-term follow-up

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.

• Study Type: Observational
• Enrollment (Actual): 601

Contacts and Locations

Study Locations

• France
  • Paris, France, 75000
    • INSERM U970 Centre de Recherche Cardiovasculaire de Paris Equipe 4, Epidémiologie Cardiovasculaire et Mort Subite

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
French prospective cohort of cardiac arrest survivors; Outcome of cardiac arrest survivors: prospective cohort of Ile-de-France	Other: Long-term follow-up; Vital and neurological follow-up

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Chair: Jean-Philippe Empana, MD, INSERM U970 Centre de Recherche Cardiovasculaire de Paris Equipe 4, Epidémiologie Cardiovasculaire et Mort Subite

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2015
• Primary Completion (Actual): January 22, 2021
• Study Completion (Actual): January 22, 2021

Study Registration Dates

• First Submitted: April 20, 2015
• First Submitted That Met QC Criteria: July 7, 2015
• First Posted (Estimate): July 10, 2015

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Cardiac arrest; outcome; neurological status
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: AOR12068