Registry of Genetically Triggered Thoracic Aortic Aneurysms (GenTAC)

遗传性胸主动脉瘤登记 (GenTAC)

• 批准号: 8104506
• 负责人: BARBARA L KRONER
• 金额: $ 32.6万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2010-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8104506
• 关键词: Blood; Cardiovascular system; Clinical; Collaborations; Communication; Communities; Contractor; Data; Data Coordinating Center; Diagnosis; Dissection; Echocardiography; Enrollment; Health Sciences; Information Dissemination; International; Interview; Life Style; Medical; Medical Records; Monitor; National Heart, Lung, and Blood Institute; Observational Study; Operative Surgical Procedures; Oregon; Outcome; Patients; Pennsylvania; Persons; Physical Examination; Policies; Records; Registries; Reporting; Research; Research Personnel; Resources; Secure; Source; Specimen; Study Subject; Texas; Thoracic Aortic Aneurysm; Tissue Sample; Universities; data sharing; design; improved; meetings; operation; patient safety; repository; symposium; web site

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.

国家遗传性触发胸主动脉瘤和心血管疾病登记处（GenTAC）的目的是通过创建数据和标本库，改善接受已知或疑似遗传性诱发胸主动脉瘤和夹层治疗的患者的诊断和管理。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 International将作为数据协调中心和主承包商。该登记研究的设计和患者入组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、俄勒冈州健康科学大学和德克萨斯大学休斯顿分校。将入组约3，000例患者，并通过病历提取、体格检查、患者访谈和其他源记录（如放射学和超声心动图报告）的提取来收集数据。血液和组织样本将被送往NHLBI生物标本储存库。一个项目网站将作为交流、数据输入、数据查询、报告和传播信息的门户。安全页面将仅对授权用户可用。网站的一部分将包括针对研究受试者和外部研究者的公共页面。登记处的活动将由NHLBI和指导委员会及业务委员会通过定期电话会议和面对面会议进行指导和监测。此外，NHLBI任命的观察性研究监测委员会（OMSB）将对总体进展、临床结局和患者安全性进行独立监测。登记研究包括一项共享数据和标本的政策，允许登记研究的研究者和登记研究以外的研究人员申请这些资源用于研究目的。