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.

Study Overview

• Status: Terminated
• Conditions: Extra-hospital Sudden Death
• Intervention / Treatment: Other: Case Controls; Other: Control subjects

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control subjects	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.
Other: Case subjects	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

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 Outcome Measures

Outcome Measure	Measure Description
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.

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: March 23, 2011
• First Submitted That Met QC Criteria: March 23, 2011
• First Posted (Estimate): March 24, 2011

Study Record Updates

• Last Update Posted (Estimate): March 24, 2011
• Last Update Submitted That Met QC Criteria: March 23, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Death; Death, Sudden
• Other Study ID Numbers: 06/6-A; 2006-A00544-47 (Other Identifier: AFSSAPS)