Intermountain Pediatric Heart Disease Research Center

描述（由申请人提供） 心脏病是儿童发病和死亡的主要原因。一 研究中心网络，既有足够的临床人口， 经过多中心试验培训的研究人员团队可以提供 标准化、盲法、高质量的研究，具有统计学能力， 改变患有心脏病的儿童的治疗方式。小学生？S 医疗中心位于犹他州的盐湖，是唯一有资格 作为这样一个网络中的一个研究中心参与其中。它作为 Intermountain心脏病儿童的领先转诊医院 西方拟议的山间儿科心脏病的总体目标 研究中心将在前瞻性、随机、多机构 提供可靠数据的试验， 关于小儿心脏病和循证儿科 药山间儿科心脏病的具体目标 研究中心的目标是：提出科学合理、统计稳健的 可以在儿科心脏病中进行的研究方案 临床研究网络;在小学招收合格的儿童？S 医疗中心;收集完整的数据并随时传达结果 在儿科心脏病临床研究网络中， 促进研究成果的快速传播。我们提出了两 儿科心脏病临床研究网络的临床研究。 方案1的总体目标，“阿昔单抗治疗儿童的疗效 与大冠状动脉瘤相比， 与常规治疗相比， 溶解或预防血栓并促进大血管重塑 冠状动脉瘤归因于川崎，总体目标是 方案2，“脱细胞人同种异体瓣膜制备（Cryovalve SGR） 与标准冻存带瓣同种异体移植物在血管重建中的比较 儿童”，是决定功能和长期耐用性的 脱细胞人同种异体瓣膜制备与当前状态 art冷冻保存的带瓣同种异体移植物。研究人员同意， 积极参与并努力遵守任何选定的协议 儿科心脏病临床研究网络。申请人 组织，儿童？的医疗中心，同意每名患者 对研究方案的运营成本进行人头计算， 小儿心脏病临床研究网络。

DESCRIPTION (provided by applicant) Heart disease is a leading cause of morbidity and mortality in children. A network of research centers with both a sufficient clinical population and team of researchers trained to conduct multi-center trials could provide standardized, blinded, quality research that has the statistical power to change the way children with heart disease are managed. Primary Children?s Medical Center, located in Salt Lake City, Utah, is uniquely qualified to participate as a research center within such a network. It serves as the leading referral hospital for children with heart disease in the Intermountain West. The overall goal of the proposed Intermountain Pediatric Heart Disease Research Center is to collaborate in prospective, randomized, multi-institutional trials that provide robust data leading to the advancement of knowledge regarding pediatric heart disease and evidence-based pediatric medicine. The specific aims of the Intermountain Pediatric Heart Disease Research Center are: to propose scientifically sound, statistically robust research protocols that can be performed within the Pediatric Heart Disease Clinical Research Network; to enroll eligible children at Primary Children?s Medical Center; and to collect complete data and readily communicate results within the Pediatric Heart Disease Clinical Research Network so as to facilitate the rapid dissemination of research findings. We propose two clinical studies for the Pediatric Heart Disease Clinical Research Network. The overall goal of protocol 1, "Efficacy of Abciximab in Treating Children with Large Coronary Aneurysms," is to compare the effectiveness of abciximab added to conventional therapy versus conventional treatment alone for dissolving or preventing thrombi and for facilitating remodeling in large coronary artery aneurysms attributed to Kawasaki disease, The overall goal of protocol 2, "Decellularized Human Allograft Valve Preparation (Cryovalve SGR) versus Standard Cryopreserved Valved Allografts for Vascular Reconstruction in Children," is to determine the function and long-term durability of decellularized human allograft valve preparation versus the current state-of-the- art cryopreserved valved allograft. The investigators agree to enthusiastically participate in and diligently adhere to any protocol selected by the Pediatric Heart Disease Clinical Research Network. The applicant organization, Primary Children?s Medical Center, agrees to the per patient capitation of operational costs for the study protocols selected by the Pediatric Heart Disease Clinical Research Network.