Baylor/Texas Children's Hospital Pediatric Heart Network

摘要 先天性和后天性心脏病是世界范围内儿童的一个重大健康问题， 在童年时期患上严重的急性疾病和残疾。需要进行研究以改善 先天性和后天性心脏病患儿的预后和生活质量。单一的研究 由于以下原因，单独行动的临床试验机构在开展充分的临床研究时遇到困难： 小患者群体。需要设计良好的多中心临床研究。这样做的目的 补助金申请是贝勒医学院（Baylor College of Medicine）/德克萨斯儿童医院（Texas Children's Hospital）心脏中心， 更新参与由国家赞助的儿科心脏网络（PHN）的临床研究中心 心脏，肺和血液研究所。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， 肌肉疾病和心律失常。技合处将支持 SA 1）在PHN内部合作，提供科学的 儿童心血管疾病和成人心血管疾病相关研究开发方面的专业知识和监督 先天性心脏病，进行这类研究，并在7年周期内公布研究结果; SA 2） 利用可用于潜在研究入组的稳健和复杂TCH患者人群，以便 在所有多中心心血管临床试验中识别、招募和保留受试者; SA 3）为了有效和 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研究以及研究和行政活动;和SA 4）利用可持续发展/技术和通信网络 独特而强大的数据集成功能，可与各种心血管数据库进行交互， 内部和外部登记研究，以利用和促进临床研究活动 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地位， 心脏外科、心脏重症监护和心血管麻醉学，5年成功跟踪 参与PHN临床研究中心的记录。TCH有一个庞大的患者群体， 在2015财年，超过350万例患者就诊。TCH位于一个多样化和快速增长的地区， 美国，这提供了多样化的患者群体。这反映在心脏中心的各种诊断中 进行了913例心脏手术室病例，1,150例心脏导管插入术，27,746例超声心动图， 目前随访了900多例单心室解剖患者（0至+18岁）。与本临床 在参与临床研究方面的存在和能力以及经过证实的记录 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的周期。

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.