- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01321918
Register and DNA Bank of Adult Extra-hospital Sudden Death (Protocol FASTER)
23. mars 2011 oppdatert av: 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.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
2000
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Nantes, Frankrike, 44093
- Nantes university hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Annen: Kontrollfag
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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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Annen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
|---|---|
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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 |
Tiltaksbeskrivelse |
|---|---|
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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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: 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
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2007
Primær fullføring (Faktiske)
1. november 2010
Studiet fullført (Faktiske)
1. november 2010
Datoer for studieregistrering
Først innsendt
23. mars 2011
Først innsendt som oppfylte QC-kriteriene
23. mars 2011
Først lagt ut (Anslag)
24. mars 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
24. mars 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. mars 2011
Sist bekreftet
1. mars 2011
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 06/6-A
- 2006-A00544-47 (Annen identifikator: AFSSAPS)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .