Registry of Genetically Triggered Thoracic Aortic Aneurysms (GenTAC)

国家遗传诱发胸主动脉瘤和心血管疾病登记处（GenTAC）的目的是通过建立数据和标本库，改善接受治疗的已知或怀疑遗传诱发的胸主动脉瘤和夹层患者的诊断和管理。收集的数据包括医疗、手术和生活方式，以及血液和组织样本。RTI国际公司将作为数据协调中心和主承包商。登记处的设计和患者登记将通过五个区域临床中心（rcc）的合作完成：康奈尔大学、约翰霍普金斯大学、宾夕法尼亚大学、俄勒冈健康科学大学和德克萨斯大学休斯顿分校。大约3000名患者将被纳入，数据将通过病历提取、体格检查、患者访谈和提取其他来源记录（如放射学和超声心动图报告）来收集。血液和组织样本将送往NHLBI生物标本库。项目网站将作为通信、数据输入、数据查询、报告和信息传播的门户。安全页面将仅供授权用户使用。网站的一部分将包括针对研究对象和外部调查人员的公共页面。书记官处的活动将通过定期电话会议和面对面会议，由国家卫生机构和指导及业务委员会指导和监测。此外，nhlbi指定的观察性研究监测委员会（OMSB）将对总体进展、临床结果和患者安全性进行独立监测。登记处包括一项共享数据和标本的政策，允许登记处以外的调查人员和研究人员为研究目的请求这些资源。

The purpose of the National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions (GenTAC) is to improve the diagnosis and management of patients receiving treatment for thoracic aortic aneurysms and dissections, which are known or suspected to be genetically induced, through the creation of a data and specimen repository. Data to be collected include medical, surgical, and lifestyle, as well as blood and tissue samples. RTI International will serve as the data coordinating center and prime contractor. The registry was designed and patient enrollment will be accomplished through the collaboration of five regional clinical centers (RCCs): Cornell University, Johns Hopkins University, University of Pennsylvania, Oregon Health Sciences University, and University of Texas at Houston. Approximately 3,000 patients will be enrolled, and data will be collected through medical record abstraction, physical examination, patient interview, and abstraction of other source records such as radiologic and echocardiography reports. Blood and tissue samples will be sent to the NHLBI biospecimen repository. A project website will serve as the portal for communications, data entry, data query, reporting, and dissemination of information. Secure pages will be available only to authorized users. A portion of the website will include public pages targeted to study subjects and outside investigators. Registry activities will be directed and monitored by the NHLBI and the Steering and Operations Committees through regular conference calls and in-person meetings. In addition, an NHLBI-appointed Observational Study Monitoring Board (OMSB) will perform independent monitoring of overall progress, clinical outcomes, and patient safety. The Registry includes a policy for sharing data and specimens that will permit Registry investigators and researchers outside the Registry to request these resources for research purposes.