- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01321918
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Nantes, Francia, 44093
- Nantes University Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: Soggetti di controllo
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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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Altro: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
|---|---|
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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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
|---|---|
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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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Vincent PROBST, Profesor, CHU de Nantes
- Cattedra di studio: Jean-Luc CHASSEVENT, Doctor, University Hospital, Angers
- Cattedra di studio: Nicolas HOURDIN, Doctor, CH de Châteaubriant
- Cattedra di studio: Yves-Marie PLUCHON, Doctor, CH de La roche-sur-yon
- Cattedra di studio: Christophe SAVIO, Doctor, CH du Mans
- Cattedra di studio: Jean-Pierre AUFFRAY, Profesor, CHU de Marseille
- Cattedra di studio: Christian HAMON, Doctor, CH de Saint-Brieuc
- Cattedra di studio: Christophe BERRANGER, Profesor, CH de Saint-Nazaire
- Cattedra di studio: Jean-Louis DUCASSE, Doctor, University Hospital, Toulouse
- Cattedra di studio: BOULANGER, Doctor, CH de Vannes
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 06/6-A
- 2006-A00544-47 (Altro identificatore: AFSSAPS)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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