Register and DNA Bank of Adult Extra-hospital Sudden Death (Protocol FASTER)
|ClinicalTrials.gov Identifier: NCT01321918|
Recruitment Status : Terminated (Recruitment difficulties)
First Posted : March 24, 2011
Last Update Posted : March 24, 2011
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 or disease||Intervention/treatment||Phase|
|Extra-hospital Sudden Death||Other: Case Controls Other: Control subjects||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Masking:||None (Open Label)|
|Official Title:||Register and DNA Bank of Adult Extra-hospital Sudden Death|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
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.
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.
- Identification of variants in DNAThe 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.
- Annual incidence of extra-hospital sudden death in adultsThe 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 adultsThe 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 adultsThe 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321918
|Nantes University Hospital|
|Nantes, France, 44093|
|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|