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The Genetic Basis of Atrial Fibrillation (AF)

2016年1月4日 更新者:University of Pittsburgh

The Genetic Basis of Atrial Fibrillation

The investigators' goal with this research is to:

  1. Establish a clinical database and a DNA bank for 1000 individuals with AF and 1000 individuals without AF.
  2. 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:

  1. Increased oversight or intervention of at-risk subjects, which might prevent unnecessary morbidity and mortality due to AF.
  2. Further insight into the pathogenesis of AF, which may lead to preventative or curative therapies.

研究概览

地位

完全的

条件

详细说明

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:

  1. Establish a clinical database and a DNA bank for 1000 individuals with AF and 1000 individuals without AF.
  2. 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:

  1. Increased oversight or intervention of at-risk subjects, which might prevent unnecessary morbidity and mortality due to AF.
  2. 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.

研究类型

观察性的

注册 (实际的)

50

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15213
        • University of Pittsburgh Medical Center/Comprehensive Heart Ctr.

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Subjects must be patients of the UPMC Cardiovascular Institute who are under the medical care of UPMC cardiologists.

描述

Inclusion Criteria:

  • 18+ years of age
  • Able to give informed consent

Exclusion Criteria:

  • Inability to provide informed consent

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:病例对照
  • 时间观点:横截面

队列和干预

团体/队列
1
Patients of the Cardiovascular Institute with known cardiac conditions and no history of atrial fibrillation.
2
Patients of the Cardiovascular Institute with known cardiac conditions and a history of atrial fibrillation.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

调查人员

  • 首席研究员:David S. Schwartzman, MD、University of Pittsburgh/UPMC

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2005年1月1日

初级完成 (实际的)

2010年1月1日

研究完成 (实际的)

2010年1月1日

研究注册日期

首次提交

2005年11月2日

首先提交符合 QC 标准的

2005年11月2日

首次发布 (估计)

2005年11月3日

研究记录更新

最后更新发布 (估计)

2016年1月5日

上次提交的符合 QC 标准的更新

2016年1月4日

最后验证

2016年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • 0405107

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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