Outcome of Cardiac Arrest Survivors (DESAC)
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|ClinicalTrials.gov Identifier: NCT02494414|
Recruitment Status : Recruiting
First Posted : July 10, 2015
Last Update Posted : March 14, 2018
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.
|Condition or disease||Intervention/treatment|
|Cardiac Arrest Survivors||Other: Long-term follow-up|
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|
|Estimated Enrollment :||600 participants|
|Official Title:||Outcome of Cardiac Arrest Survivors: Prospective Cohort of Ile-de-France|
|Actual Study Start Date :||July 24, 2015|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
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
- Cerebral Performance Categories Scale [ Time Frame: at last follow-up (48 months max) ]Combined vital and neurological status
- SF-36 (Short-Form General Health Survey) [ Time Frame: at last follow-up (48 months max) ]Quality of life
- Overall Performance Categories (OPC) [ Time Frame: at last follow-up (48 months max) ]
- Activities of Daily Living (ADL) scale [ Time Frame: at last follow-up (48 months max) ]
- New cardiovascular events [ Time Frame: at last follow-up (48 months max) ]
- New York Heart Association (NYHA) status [ Time Frame: at last follow-up (48 months max) ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494414
|Contact: Alain Cariou, MD||00 33 1 58 41 25 firstname.lastname@example.org|
|Contact: Laurence Lecomte, PhD||+33 1 71 19 64 email@example.com|
|INSERM U970 Centre de Recherche Cardiovasculaire de Paris Equipe 4, Epidémiologie Cardiovasculaire et Mort Subite||Recruiting|
|Paris, France, 75000|
|Contact: Alain Cariou, MD 00 33 1 58 41 25 01 firstname.lastname@example.org|
|Contact: Laurence Lecomte, PhD +33 1 71 19 64 94 email@example.com|
|Study Chair:||Jean-Philippe Empana, MD||INSERM U970 Centre de Recherche Cardiovasculaire de Paris Equipe 4, Epidémiologie Cardiovasculaire et Mort Subite|