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

NCT01321918 | Terminated

• 2 other identifiers: 06/6-A2006-A00544-47
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Extra-hospital Sudden Death

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• Annual incidence of extra-hospital sudden death in adults

• Annual mortality related to extra-hospital sudden death in adults

• Characterization of victims of extra-hospital sudden death in adults

Study Arms (2)

Case subjects

OTHER

Other: Case Controls

Control subjects

OTHER

Other: Control subjects

Interventions

Case Controls OTHER

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.

Case subjects

Control subjects OTHER

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.

Control subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Violent death : criminal, suicidal or accidental.
• 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,

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Study Officials

• Vincent PROBST, Profesor

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 24, 2011
• Study Start: June 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: March 24, 2011

Record last verified: 2011-03

Locations

FR (1)