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

Purpose

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.

Condition	Intervention
Extra-hospital Sudden Death	Other: Case Controls Other: Control subjects

Study Type:	Interventional
Study Design:	Masking: Open Label
Official Title:	Register and DNA Bank of Adult Extra-hospital Sudden Death

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:

Identification of variants in DNA [ Designated as safety issue: No ]
The primary endpoint is the identification of variants (polymorphisms and / or mutations) in DNA significantly associated with risk of extra-hospital sudden death in adults. Study populations are : (i) the entire population of case subjects included in the DNA bank (ii) two subpopulations at high risk of sudden death : patients with a history of myocardial infarction and patients with LVEF < 30 %. The variable analyzed is the nucleotide sequence of DNA in populations of case and control subjects.

Secondary Outcome Measures:

Annual incidence of extra-hospital sudden death in adults [ Designated as safety issue: No ]
The annual incidence of extra-hospital sudden death in adults. The variable analyzed is the number of incident cases per year of extra-hospital sudden death in adults.
Annual mortality related to extra-hospital sudden death in adults [ Designated as safety issue: No ]
The annual mortality related to extra-hospital sudden death in adults. The variable analyzed is the number of annual deaths due to sudden death in adults.
Characterization of victims of extra-hospital sudden death in adults [ Designated as safety issue: No ]
The characterization of victims of extra-hospital sudden death in adults, their medical care in emergency and their future from D0 to D28. Variables analyzed are clinical data are collected in case report forms.

Estimated Enrollment:	2000
Study Start Date:	June 2007
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Case subjects	Other: 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.
Control subjects	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.

Arms

Assigned Interventions

Case subjects

Other: 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.

Control subjects

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321918

Locations

France
Nantes University Hospital
Nantes, France, 44093

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator:	Vincent PROBST, Profesor	CHU de Nantes
Study Chair:	Jean-Luc CHASSEVENT, Doctor	University Hospital, Angers
Study Chair:	Nicolas HOURDIN, Doctor	CH de Châteaubriant
Study Chair:	Yves-Marie PLUCHON, Doctor	CH de la Roche-sur-Yon
Study Chair:	Christophe SAVIO, Doctor	CH du Mans
Study Chair:	Jean-Pierre AUFFRAY, Profesor	CHU de Marseille
Study Chair:	Christian HAMON, Doctor	CH de Saint-Brieuc
Study Chair:	Christophe BERRANGER, Profesor	CH de Saint-Nazaire
Study Chair:	Jean-Louis DUCASSE, Doctor	University Hospital, Toulouse
Study Chair:	BOULANGER, Doctor	CH de Vannes

More Information

No publications provided

Responsible Party:	Anne OMNES, Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT01321918 History of Changes
Other Study ID Numbers:	06/6-A, 2006-A00544-47
Study First Received:	March 23, 2011
Last Updated:	March 23, 2011
Health Authority:	France : AFSSAPS

Additional relevant MeSH terms:

Death
Death, Sudden
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013