Register and DNA Bank of Adult Extra-hospital Sudden Death (Protocol FASTER)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-11-30

Brief Summary

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The main objective of this study is the formation of a DNA bank to realise a case-control genetic study designed to identify sequence variations in DNA that predispose to sudden cardiac death in adults.

The secondary objective of this study is the creation of a register for epidemiological surveillance of adult extra-hospital sudden death.

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Detailed Description

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Conditions

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Extra-hospital Sudden Death

Study Design

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Blinding Strategy

NONE

Study Groups

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Case subjects

Group Type OTHER

Case Controls

Intervention Type OTHER

A blood sample of 10 ml (2 x 5 ml) on two EDTA tubes will be realised on a route of vascular development place in the context of medical practice.Clinical data will be indicated in the CRF and the computerized database. In the event an eligible patient has not been included during his support by an emergency ambulance service but, after successful resuscitation, he has been hospitalised in a cardiology department, its inclusion may be realised during the hospitalization by a physician investigator of the study. A blood sample of 10 ml of 2 EDTA tubes will be realised on a route of vascular development in the context of routine care.

Control subjects

Group Type OTHER

Control subjects

Intervention Type OTHER

A blood sample of 10 ml (2 x 5 ml) on two EDTA tubes will be realised and clinical data will be indicated in the CRF and the computerized database.

Interventions

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Case Controls

A blood sample of 10 ml (2 x 5 ml) on two EDTA tubes will be realised on a route of vascular development place in the context of medical practice.Clinical data will be indicated in the CRF and the computerized database. In the event an eligible patient has not been included during his support by an emergency ambulance service but, after successful resuscitation, he has been hospitalised in a cardiology department, its inclusion may be realised during the hospitalization by a physician investigator of the study. A blood sample of 10 ml of 2 EDTA tubes will be realised on a route of vascular development in the context of routine care.

Intervention Type OTHER

Control subjects

A blood sample of 10 ml (2 x 5 ml) on two EDTA tubes will be realised and clinical data will be indicated in the CRF and the computerized database.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults ≥ 18 years of age.
* Persons who experienced sudden death defined as follows :cardiovascular arrest of non traumatic origin that occurred unexpectedly within an hour after the start of any prodromes.
* Patients not hospitalized at the time of sudden death.
* Case subjects :
* Adults ≥ 18 years of age.
* Persons who experienced sudden death defined as follows :cardiovascular arrest of non traumatic origin that occurred unexpectedly within an hour after the start of any prodromes.
* Patients not hospitalized at the time of sudden death.
* Patients supported clinically by an emergency ambulance service.
* Control subjects :
* Adults ≥ 18 years of age.
* Adults hospitalized in an cardiac intensive care unit.

Exclusion Criteria

* Violent death : criminal, suicidal or accidental.
* Case subjects :
* Violent death : criminal, suicidal or accidental.
* Identified cause of death extra-cardiac : neurological cause, hypoxia, pulmonary embolism, aortic rupture or other identified extra-cardiac cause.
* In accordance with Articles L1221-5 L1221-L1221-8 and 8-1 of the Code of Public Health, the categories of persons are excluded from research due to the fact that it can be achieved with an efficiency comparable over another class of people :
* Adult subject to legal protection measure,
* Pregnant woman,
* Parturient,
* Breastfeeding mother,
* Person deprived of liberty,
* Person hospitalised without his consent,
* Person admitted to a medical or socially facility.
* Control subjects :
* History of sudden death,
* Documented history of ventricular fibrillation,
* History of sustained ventricular tachycardia (lasting longer than 30 seconds) documented.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No