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

This study has been terminated.
(Recruitment difficulties)
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01321918
First received: March 23, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted

March 23, 2011
March 23, 2011
June 2007
November 2010   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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.
Same as current
Not Provided
Not Provided
 
Register and DNA Bank of Adult Extra-hospital Sudden Death (Protocol FASTER)
Register and DNA Bank of Adult Extra-hospital Sudden Death

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.

Not Provided
Interventional
Not Provided
Masking: Open Label
Extra-hospital Sudden Death
  • 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.
  • Case subjects
    Intervention: Other: Case Controls
  • Control subjects
    Intervention: Other: Control subjects
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2000
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01321918
06/6-A, 2006-A00544-47
No
Anne OMNES, Nantes University Hospital
Nantes University Hospital
Not Provided
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
Nantes University Hospital
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP