- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03491202
The Genetic Basis for Atrial Fibrillation
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Atrial fibrillation (AF) is reaching epidemic proportions in the aging U.S. and European populations, but the mechanisms of increased susceptibility to atrial fibrillation are still unknown. In this study, the investigators look to further examine genetic and medical co-morbidity influence of atrial fibrillation duration and response to medications. In Specific Aim 1, the investigators propose the creation of a Veterans Affairs AF Biorepository (VAAFBio), which is a resource that will collect and store clinical, demographic, blood and DNA samples from patients with atrial fibrillation to aide this study and future studies of this type in the VA population. In Specific Aim 2, the investigators will examine common genetic polymorphisms in veteran patients with atrial fibrillation and examine gene-environment interactions with risk factors for atrial fibrillation.
Patients will be identified through the VA inpatient and outpatient clinic, and will be approached for inclusion in the study. The target enrollment for the research and biorepository is 600 participants. A detailed family history, medical background, study questionnaires and a blood sample will then be obtained by the principal investigator or a research coordinator, following written informed consent under a protocol approved by the Jesse Brown VA Institutional Review Board. Once enough samples are collected, coded DNA samples will be sent out to analyze for linkage to known/candidate loci for AF.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Katherine A Durham, APN
- Telefonnummer: 3125696635
- E-mail: Katherine.durham@va.gov
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Rekruttering
- Jesse Brown VA Medical Center
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Kontakt:
- Katherine A Durham, MS, APN
- Telefonnummer: 312-569-6635
- E-mail: Katherine.durham@va.gov
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Ledende efterforsker:
- Katherine A Durham, MS, APN
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Ledende efterforsker:
- Dawood Darbar, MD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Subjects must be at least 18 years of age, and up to 100.
- Subjects must have a documented history of atrial fibrillation by ECG, ECHO, and or Holter monitor event recorder.
- Subjects must be willing to give written, informed consent.
Exclusion Criteria:
- Patients with a history of AF or atrial flutter that is only associated with cardiac surgery will be excluded from the study.
- Subjects who cannot speak English will be excluded from the study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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atrial fibrillation
Patients with a diagnosis of atrial fibrillation will be eligible for enrollment
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Symptoms related to atrial fibrillation (chest pain, dyspnea, palpitations)
Tidsramme: 1 year
|
1 year
|
heart rate
Tidsramme: 1 year
|
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 977544
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Atrieflimren
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W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
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Pusan National University HospitalIkke rekrutterer endnuHjerteimplanterbar elektronisk enhed | Atrial High Rate EpisodeKorea, Republikken
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W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
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Academisch Medisch Centrum - Universiteit van Amsterdam...Tilmelding efter invitationKortkoblet idiopatisk ventrikulær fibrillationHolland
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Assiut UniversityTrukket tilbageASD2 (Secundum atrial septal defekt)
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Henry Ford Health SystemTrukket tilbage
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Nobles Medical Technologies II IncTilmelding efter invitationForamen Ovale, Patent | Septal defekt, atrial | Septaldefekt, HjerteForenede Stater, Italien
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HeartStitch.ComUkendtForamen Ovale, Patent | Septal defekt, atrial | Septaldefekt, HjerteForenede Stater
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Occlutech International ABAfsluttetSecundum atrial septal defekter
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University Hospital, Basel, SwitzerlandUniversity Hospital GreifswaldAfsluttetAtrium; Fibrillering | Arytmi AtrialTyskland, Schweiz