Randomized Clinical Trials for Pediatric Heart Disease

小儿心脏病的随机临床试验

• 批准号: 6401212
• 负责人: J Philip SAUL
• 金额: $ 35.44万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-01 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6401212
• 关键词: amiodarone; arrhythmia; blood flow measurement; blood vessel occlusion; cardiovascular disorder therapy; child (0-11); clinical trials; collateral circulation; congenital heart disorder; cooperative study; drug screening /evaluation; heart catheterization; heart function; heart surgery; hemostasis; human subject; human therapy evaluation; patient oriented research; pediatrics; postoperative state; preoperative state; therapy

DESCRIPTION (provided by the applicant) The Children?s Heart Program of South Carolina is a statewide consortium of pediatric cardiologists, who care for 90% of the 3.7 million residents in the state. This consortium has all the critical elements for a center in the proposed research network: adequate patient volume, clinical research infrastructure, a track record of subject enrollment, and a demonstrated dedication to hypothesis driven clinical research. The applicant center, MUSC, is the tertiary referral center for the Children?s Heart Program. Current MUSC faculty have participated as PI?s in a total of 20 multicenter clinical trials or registries (10 open, 2 under IRB review). The PI of this application has been the lead investigator nationally in 4 of the 20. These protocols range from industry sponsored drug or device trials, to an NIH sponsored drug trial for fetal heart block, to an NIH prospective registry. The faculty also currently runs 11 local clinical research protocols. Participation in all of these protocols is supported by a dedicated pediatric cardiac research support group with 2 full time RN coordinators and an additional RN FTE. The combined resources of high volume and strong research infrastructure have enabled the PI?s at MUSC to be one of the top 2 subject recruiters in 6 of the 18 completed or active multicenter studies. As requested, the proposal contains a short-term and a long-term protocol. Short-Term. Randomized Trial of Aortopulmonary Collateral Coil Occlusion Prior to Fontan. Multiple factors influence morbidity and mortality for single ventricle patients undergoing Fontan operation. One considered recently is the presence of APC?s. However, multiple retrospective studies have failed to clearly delineate the role of APC?s or their optimum management. This protocol will prospectively evaluate the role of APC?s in postoperative Fontan hemodynamics and morbidity, and determine the importance of preoperative coil embolization in their management. Long-Term. Randomized Trial of Amiodarone vs Cooled- Tip Catheter Ablation for Treatment of Recurrent Intra-atrial Reentry Tachycardia (IART) in Patients with Congenital Heart Disease. IART, the single largest cause of morbidity late after repair of congenital heart disease, is often life-threatening, frustrating to treat and has no clearly superior therapy. This protocol will prospectively compare the most successful medical and catheter therapies for IART. The primary endpoint during a minimum of 2 years follow-up will be IART recurrence after successful ablation, or after drug loading and cardioversion.

描述（由申请人提供） 孩子们？南卡罗来纳州的心脏计划是一个全州范围的联盟， 儿科心脏病专家，他们照顾370万居民中的90%， 状态这个联盟拥有在世界上建立一个中心的所有关键要素。 拟议的研究网络：足够的患者数量，临床研究 基础设施、受试者入组的跟踪记录和已证明的 致力于假设驱动的临床研究。申请人中心，MUSC， 是儿童的三级转诊中心吗的心脏计划。当前MUSC 教职员工作为PI参与了吗？共20项多中心临床试验 或登记研究（10项开放，2项正在接受IRB审查）。本申请的PI 在20个国家中的4个国家担任首席调查员。这些协议的范围 从行业赞助的药物或器械试验，到NIH赞助的药物试验， 对于胎心传导阻滞，NIH前瞻性登记研究。教师也 目前正在执行11项本地临床研究方案。参加所有 这些方案得到专门的儿科心脏研究支持， 一组有2名全职RN协调员和额外的RN FTE。将合并的 大量的资源和强大的研究基础设施使 派？在18个国家中，有6个国家的MUSC是排名前两位的学科招聘人员之一。 已完成或正在进行的多中心研究。根据要求，该提案载有 短期和长期方案。 短期内主动脉-肺动脉侧支弹簧圈闭塞术的随机试验 在Fontan之前。多种因素影响单次手术的发病率和死亡率 脑室Fontan手术患者。最近考虑的一个问题是 APC的存在？S.然而，多项回顾性研究未能 明确界定APC的作用？或其最佳管理。本议定书 将前瞻性地评估APC的作用？术后Fontan 血流动力学和发病率，并确定术前弹簧圈的重要性 栓塞治疗。 长期。胺碘酮与冷却头端导管消融术的随机试验 用于治疗患者的复发性房内折返性心动过速（IART） 先天性心脏病IART，发病率的单一最大原因 先天性心脏病后期修复后，往往危及生命， 令人沮丧的治疗，并没有明显的上级治疗。本方案将 前瞻性比较最成功的药物和导管治疗， IART。至少2年随访期间的主要终点为IART 成功消融后或药物负荷和心脏复律后复发。