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- Ensaio Clínico NCT00248326
The Genetic Basis of Atrial Fibrillation (AF)
The Genetic Basis of Atrial Fibrillation
The investigators' goal with this research is to:
- Establish a clinical database and a DNA bank for 1000 individuals with AF and 1000 individuals without AF.
- Directly test the hypothesis that known functional polymorphisms in the coding sequences and the promoter regions of cardiac genes (ion channels and genes known to affect survival in the setting of left ventricular dysfunction) predispose individuals to AF.
Over the past decade, advancing techniques and technologies for gene characterization have yielded significant clues as to the molecular mechanism of certain human heart rhythm disorders. The role of ion channel polymorphisms in subjects with AF is unknown. Similarly, it is also not known whether polymorphisms in other genes have an impact on the risk of AF.
The ability to characterize genomic "at-risk" profiles would have many potential benefits for patient care. Paramount among these is:
- Increased oversight or intervention of at-risk subjects, which might prevent unnecessary morbidity and mortality due to AF.
- Further insight into the pathogenesis of AF, which may lead to preventative or curative therapies.
Visão geral do estudo
Status
Condições
Descrição detalhada
Atrial fibrillation (AF), a heart rhythm disorder, is a major health problem. As many as 3 million US persons are afflicted; this number is expected to rise significantly in coming decades because AF incidence is directly correlated with age. AF is significantly associated with cardiovascular morbidity and mortality.
Our goal with this research is to:
- Establish a clinical database and a DNA bank for 1000 individuals with AF and 1000 individuals without AF.
- Directly test the hypothesis that known functional polymorphisms in the coding sequences and the promoter regions of cardiac genes (ion channels and genes known to affect survival in the setting of left ventricular dysfunction) predispose individuals to AF.
Over the past decade, advancing techniques and technologies for gene characterization have yielded significant clues as to the molecular mechanism of certain human heart rhythm disorders. The role of ion channel polymorphisms in subjects with AF is unknown. Similarly, it is also not known whether polymorphisms in other genes have an impact on the risk of AF.
The ability to characterize genomic "at-risk" profiles would have many potential benefits for patient care. Paramount among these is:
- Increased oversight or intervention of at-risk subjects, which might prevent unnecessary morbidity and mortality due to AF.
- Further insight into the pathogenesis of AF, which may lead to preventative or curative therapies.
Subjects will be recruited from the patient pool of the Cardiovascular Institute (including the Comprehensive Heart Center and the PUH Outpatient Cardiology Clinic). For each subject enrolled, we will record demographic information; etiology and details of heart disease; family history of heart disease; non-cardiac medical history; physical exam findings; medicinal therapy; and results of prior cardiac testing (such as echocardiograms [Echo], gated blood pool scans of heart function [MUGAs], exercise stress tests [ESTs] cardiac catheterizations, and clinical electrophysiology studies [EP Studies]. Records will be maintained with identifiers in a locked file cabinet in the office of the Principal Investigator.
A blood sample of ~10 ml will be drawn from each participating subject on the day of enrollment. Blood samples will be drawn only once from each subject. There is no further follow up required for the subject. Blood will be sent to the University of Pittsburgh School of Medicine Cardiovascular Research Center where nucleated cells will be isolated from whole blood by centrifugation. DNA will be isolated from nucleated cells and stored at the Cardiovascular Research Center (on the 17th floor of the Biomedical Science Tower). All DNA samples will be coded to ensure confidentiality, and maintained in a locked freezer for the duration of the study (5 years). Samples will be destroyed if requested by the subject. Samples (blood and DNA) will be under the control of the Principal Investigator. The DNA samples will be used to identify polymorphisms in ion channel genes, as well as other genes that may be associated with an increased risk of AF. Genotyping of polymorphisms will be performed on the genomic DNA. The genomic DNA will be amplified by polymerase chain reaction method using gene-specific primers. For each polymorphism, genotype will be identified. We will determine the frequency of that genotype in our study population, and attempt to define significant associations with AF.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh Medical Center/Comprehensive Heart Ctr.
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- 18+ years of age
- Able to give informed consent
Exclusion Criteria:
- Inability to provide informed consent
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Controle de caso
- Perspectivas de Tempo: Transversal
Coortes e Intervenções
Grupo / Coorte |
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1
Patients of the Cardiovascular Institute with known cardiac conditions and no history of atrial fibrillation.
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2
Patients of the Cardiovascular Institute with known cardiac conditions and a history of atrial fibrillation.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: David S. Schwartzman, MD, University of Pittsburgh/UPMC
Publicações e links úteis
Publicações Gerais
- Gensini F, Padeletti L, Fatini C, Sticchi E, Gensini GF, Michelucci A. Angiotensin-converting enzyme and endothelial nitric oxide synthase polymorphisms in patients with atrial fibrillation. Pacing Clin Electrophysiol. 2003 Jan;26(1P2):295-8. doi: 10.1046/j.1460-9592.2003.00036.x.
- Lai LP, Lin JL, Lin CS, Yeh HM, Tsay YG, Lee CF, Lee HH, Chang ZF, Hwang JJ, Su MJ, Tseng YZ, Huang SK. Functional genomic study on atrial fibrillation using cDNA microarray and two-dimensional protein electrophoresis techniques and identification of the myosin regulatory light chain isoform reprogramming in atrial fibrillation. J Cardiovasc Electrophysiol. 2004 Feb;15(2):214-23. doi: 10.1046/j.1540-8167.2004.03423.x.
- Gaudino M, Andreotti F, Zamparelli R, Di Castelnuovo A, Nasso G, Burzotta F, Iacoviello L, Donati MB, Schiavello R, Maseri A, Possati G. The -174G/C interleukin-6 polymorphism influences postoperative interleukin-6 levels and postoperative atrial fibrillation. Is atrial fibrillation an inflammatory complication? Circulation. 2003 Sep 9;108 Suppl 1:II195-9. doi: 10.1161/01.cir.0000087441.48566.0d.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 0405107
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