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

Extra-hospital Sudden Death Clinical Trial

Official title:

Register and DNA Bank of Adult Extra-hospital Sudden Death

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01321918
• Other study ID #: 06/6-A
• Secondary ID: 2006-A00544-47
• Status: Terminated
• Phase: N/A
• First received: March 23, 2011
• Last updated: March 23, 2011
• Start date: June 2007
• Est. completion date: November 2010

Study information

• Verified date: March 2011
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : AFSSAPS
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2000
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Masking: Open Label

Related Conditions & MeSH terms

• Death
• Death, Sudden
• Extra-hospital Sudden Death

Intervention

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
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.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of variants in DNA	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.		No
Secondary	Annual incidence of extra-hospital sudden death in adults	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.		No
Secondary	Annual mortality related to extra-hospital sudden death in adults	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.		No
Secondary	Characterization of victims of extra-hospital sudden death in adults	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.		No