Clinical trial NCT01321918: Register and DNA Bank of Adult Extra-hospital Sudden Death (Protocol FASTER)
Official title: Register and DNA Bank of Adult Extra-hospital Sudden Death
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Extra-hospital Sudden Death
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2011-03-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: 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.


Eligibility criteria: INCLUSION CRITERIA :

* Inclusion criteria for register :
* 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.
* Inclusion criteria for DNA bank :
* 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 :

* Exclusion criteria for register :
* Violent death : criminal, suicidal or accidental.
* Exclusion criteria for DNA bank :
* 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.

Primary outcomes:
measure: Identification of variants in DNA
Secondary outcomes:
measure: Annual incidence of extra-hospital sudden death in adults
measure: Annual mortality related to extra-hospital sudden death in adults
measure: Characterization of victims of extra-hospital sudden death in adults
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Vincent PROBST, Profesor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Angers
name: Jean-Luc CHASSEVENT, Doctor
role: STUDY_CHAIR
affiliation: CH de Châteaubriant
name: Nicolas HOURDIN, Doctor
role: STUDY_CHAIR
affiliation: CH de la Roche-sur-Yon
name: Yves-Marie PLUCHON, Doctor
role: STUDY_CHAIR
affiliation: CH du Mans
name: Christophe SAVIO, Doctor
role: STUDY_CHAIR
affiliation: CHU de Marseille
name: Jean-Pierre AUFFRAY, Profesor
role: STUDY_CHAIR
affiliation: CH de Saint-Brieuc
name: Christian HAMON, Doctor
role: STUDY_CHAIR
affiliation: CH de Saint-Nazaire
name: Christophe BERRANGER, Profesor
role: STUDY_CHAIR
affiliation: University Hospital, Toulouse
name: Jean-Louis DUCASSE, Doctor
role: STUDY_CHAIR
affiliation: CH de Vannes
name: BOULANGER, Doctor
role: STUDY_CHAIR
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