Trial record 13 of 193 for:    Recruiting, Not yet recruiting, Available Studies | "Heart Arrest"

Outcome of Cardiac Arrest Survivors (DESAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02494414
Recruitment Status : Recruiting
First Posted : July 10, 2015
Last Update Posted : March 14, 2018
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment
Cardiac Arrest Survivors 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
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Cerebral Performance Categories Scale [ Time Frame: at last follow-up (48 months max) ]
    Combined vital and neurological status

Secondary Outcome Measures :
  1. SF-36 (Short-Form General Health Survey) [ Time Frame: at last follow-up (48 months max) ]
    Quality of life

  2. Overall Performance Categories (OPC) [ Time Frame: at last follow-up (48 months max) ]
  3. Activities of Daily Living (ADL) scale [ Time Frame: at last follow-up (48 months max) ]
  4. New cardiovascular events [ Time Frame: at last follow-up (48 months max) ]
  5. New York Heart Association (NYHA) status [ Time Frame: at last follow-up (48 months max) ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Inclusion Criteria:

  • Patients alive after resuscitation from a 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02494414

Contact: Alain Cariou, MD 00 33 1 58 41 25 01
Contact: Laurence Lecomte, PhD +33 1 71 19 64 94

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   
Contact: Laurence Lecomte, PhD    +33 1 71 19 64 94   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Study Chair: Jean-Philippe Empana, MD INSERM U970 Centre de Recherche Cardiovasculaire de Paris Equipe 4, Epidémiologie Cardiovasculaire et Mort Subite

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT02494414     History of Changes
Other Study ID Numbers: AOR12068
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cardiac arrest
neurological status

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases