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临床试验/NCT02494414
NCT02494414已完成不适用

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

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 601 人开始时间: 2015年7月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
601
试验地点
2
主要终点
Cerebral Performance Categories Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Cerebral Performance Categories Scale

时间窗: at last follow-up (48 months max)

Combined vital and neurological status

次要结局

  • SF-36 (Short-Form General Health Survey)(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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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