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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02494414
Other study ID # AOR12068
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 24, 2015
Est. completion date January 22, 2021

Study information

Verified date April 2021
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 601
Est. completion date January 22, 2021
Est. primary completion date January 22, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Long-term follow-up
Vital and neurological follow-up

Locations

Country Name City State
France INSERM U970 Centre de Recherche Cardiovasculaire de Paris Equipe 4, Epidémiologie Cardiovasculaire et Mort Subite Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cerebral Performance Categories Scale Combined vital and neurological status at last follow-up (48 months max)
Secondary SF-36 (Short-Form General Health Survey) Quality of life at last follow-up (48 months max)
Secondary Overall Performance Categories (OPC) at last follow-up (48 months max)
Secondary Activities of Daily Living (ADL) scale at last follow-up (48 months max)
Secondary New cardiovascular events at last follow-up (48 months max)
Secondary New York Heart Association (NYHA) status at last follow-up (48 months max)