Baylor/Texas Children's Hospital Pediatric Heart Network

摘要 先天性和获得性心脏病是全世界儿童的一个重大健康问题，是 在儿童时期患有严重的急性疾病和残疾。需要进行研究来改善 先天性和获得性心脏病儿童的结局和生活质量。单一研究 由于以下原因，单独行动的中心在进行足够有力的临床研究方面遇到了困难 患者人数较少。需要设计良好的多中心临床研究。这样做的目的是 资助申请为贝勒医学院(BCM)/德克萨斯儿童医院(TCH)心脏中心 作为国家资助的儿科心脏网络(PHN)临床研究中心重新参与 心肺血研究所。PHN的目标是评估治疗和管理策略 对于患有先天性心脏病的儿童和成人以及患有炎症性心脏病的儿童，心脏 肌肉疾病，心律失常，通过多中心的临床研究。BCM/TCH将支持 PHN通过追求以下具体目标：SA1)在PHN内合作，提供科学 在与儿童心血管疾病和成人相关的研究发展方面的专门知识和监督 先天性心脏病，进行此类研究并在7年周期内传播结果；SA2)至 利用可用于潜在研究登记的强大而复杂的TCH患者群体，以便 确定、招募和留住所有多中心心血管临床试验的参与者；SA3)以有效和 有效地管理和沟通所有必要的资源，以实现最佳行为和绩效 支持PHN研究和活动，包括研究和行政；以及SA4)利用BCM/TCH 独特且强大的数据集成功能，可与各种心血管数据库和 内部和外部注册，以利用和促进临床研究活动 在整个PHN。贝勒/TCH心脏中心在心脏病学方面拥有多学科的领导经验， 心脏外科、心脏危重护理和心血管麻醉学成功的5年跟踪 作为PHN临床研究中心的参与记录。TCH有大量的患者群体提供了 2015财年，患者就诊人数超过350万人次。TCH位于一个多元化和快速增长的地区，拥有 美国，提供多样化的患者群体。这一点反映在心脏中心的各种诊断中 接受了913例心脏手术室病例，1150例心导管术，27746例超声心动图， 目前跟踪观察了900多名单脑室解剖患者(0至+18岁)。有了这个临床 参与临床研究的存在和能力，以及经过验证的跟踪记录 贝勒/TCH心脏中心计划在未来7年内继续成为领先的临床研究中心 PHN的循环。

Abstract Congenital and acquired heart disease is a significant health problem in children worldwide and is responsible for considerable acute illness and disability throughout childhood. Research is needed to improve the outcomes and quality of life for children living with congenital and acquired heart disease. Single research centers acting alone encounter difficulties with conducting adequately powered clinical research studies due to small patient populations. Well-designed multicenter clinical research studies are needed. The purpose of this grant application is for Baylor College of Medicine (BCM)/Texas Children's Hospital (TCH) Heart Center to renew participation as a Clinical Research Center of the Pediatric Heart Network (PHN) sponsored by National Heart, Lung, and Blood Institute. The goal of the PHN is to evaluate therapeutic and management strategies for children and adults with congenital heart defects and for children with inflammatory heart disease, heart muscle disease, and arrhythmias through multicenter clinical research. BCM/TCH will support the goals of the PHN by pursuing the following specific aims: SA1) To work cooperatively within the PHN to provide scientific expertise and supervision in development of studies related to pediatric cardiovascular disease and adult congenital heart disease, to conduct such studies and disseminate results over the 7-year cycle; SA2) To utilize the robust and complex TCH patient population available for potential study enrollment in order to identify, enroll and retain participants in all multi-center cardiovascular clinical trials; SA3) To effectively and efficiently manage and communicate all necessary resources for optimal conduct and performance in order to support PHN studies as well as activities, both research and administrative; and SA4) To utilize BCM/TCH's unique and robust data integration capabilities to interface with a variety of cardiovascular databases and registries, both internal and external, in order to leverage and contribute to clinical research activities throughout the PHN. Baylor/TCH Heart Center has experienced multidisciplinary leadership in Cardiology, Cardiac Surgery, Cardiac Critical Care, and Cardiovascular Anesthesiology with a successful 5-year track record of participation as a PHN clinical research center. TCH has a large patient population having provided over 3.5 million patient encounters in FY2015. TCH is located in a diverse and fast-growing region with the U.S., which provides a diverse patient population. This is reflected in the Heart Center's diverse diagnoses undergoing over 913 cardiac operating room cases, 1,150 cardiac catheterizations, 27,746 echocardiograms, and currently following more than 900 patients (0 to +18 years) with single ventricle anatomy. With this clinical presence and capabilities in conjunction with a proven track record in participating in clinical research Baylor/TCH Heart Center proposes to continue to be a leading Clinical Research Center within the next 7-year cycle of the PHN.