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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Register and DNA Bank of Adult Extra-hospital Sudden Death

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.


Detailed Summary:
Sponsor: Nantes University Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Nantes University Hospital

Dates:
Date Received: March 23, 2011
Date Started: June 2007
Date Completion:
Last Updated: March 23, 2011
Last Verified: March 2011