Clinical trial NCT02494414: Outcome of Cardiac Arrest Survivors
Official title: Outcome of Cardiac Arrest Survivors: Prospective Cohort of Ile-de-France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest Survivors
Keywords: Cardiac arrest
outcome
neurological status
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-07-10
Enrollment: 601
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Cerebral Performance Categories Scale
timeFrame: at last follow-up (48 months max)
Secondary outcomes:
measure: SF-36 (Short-Form General Health Survey)
timeFrame: at last follow-up (48 months max)
measure: Overall Performance Categories (OPC)
timeFrame: at last follow-up (48 months max)
measure: Activities of Daily Living (ADL) scale
timeFrame: at last follow-up (48 months max)
measure: New cardiovascular events
timeFrame: at last follow-up (48 months max)
measure: New York Heart Association (NYHA) status
timeFrame: at last follow-up (48 months max)
Other outcomes:
Locations:
city: Paris
country: France
facility: INSERM U970 Centre de Recherche Cardiovasculaire de Paris Equipe 4, Epidémiologie Cardiovasculaire et Mort Subite
Study officials:
affiliation: INSERM U970 Centre de Recherche Cardiovasculaire de Paris Equipe 4, Epidémiologie Cardiovasculaire et Mort Subite
name: Jean-Philippe Empana, MD
role: STUDY_CHAIR
References: