- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01321918
Register and DNA Bank of Adult Extra-hospital Sudden Death (Protocol FASTER)
23. marts 2011 opdateret af: Nantes University Hospital
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
2000
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Nantes, Frankrig, 44093
- Nantes University Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Andet: Kontrolfag
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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.
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Andet: Case subjects
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
|---|---|
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Identification of variants in DNA
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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.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
|---|---|
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Annual incidence of extra-hospital sudden death in adults
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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.
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Annual mortality related to extra-hospital sudden death in adults
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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.
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Characterization of victims of extra-hospital sudden death in adults
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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.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Vincent PROBST, Profesor, CHU de Nantes
- Studiestol: Jean-Luc CHASSEVENT, Doctor, University Hospital, Angers
- Studiestol: Nicolas HOURDIN, Doctor, CH de Châteaubriant
- Studiestol: Yves-Marie PLUCHON, Doctor, CH de La roche-sur-yon
- Studiestol: Christophe SAVIO, Doctor, CH du Mans
- Studiestol: Jean-Pierre AUFFRAY, Profesor, CHU de Marseille
- Studiestol: Christian HAMON, Doctor, CH de Saint-Brieuc
- Studiestol: Christophe BERRANGER, Profesor, CH de Saint-Nazaire
- Studiestol: Jean-Louis DUCASSE, Doctor, University Hospital, Toulouse
- Studiestol: BOULANGER, Doctor, CH de Vannes
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2007
Primær færdiggørelse (Faktiske)
1. november 2010
Studieafslutning (Faktiske)
1. november 2010
Datoer for studieregistrering
Først indsendt
23. marts 2011
Først indsendt, der opfyldte QC-kriterier
23. marts 2011
Først opslået (Skøn)
24. marts 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
24. marts 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. marts 2011
Sidst verificeret
1. marts 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 06/6-A
- 2006-A00544-47 (Anden identifikator: AFSSAPS)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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