Randomized Clinical Trials for Pediatric Heart Disease

小儿心脏病的随机临床试验

• 批准号: 6797845
• 负责人: J Philip SAUL
• 金额: $ 48.45万
• 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/6797845
• 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） 南卡罗来纳州儿童心脏计划是一个全州范围的联盟 儿科心脏病专家，他们为美国 370 万居民中的 90% 提供护理 状态。该联盟拥有该中心的所有关键要素 拟议的研究网络：充足的患者量、临床研究 基础设施、科目入学记录以及经过证明的 致力于假设驱动的临床研究。申请中心，MUSC， 是儿童心脏计划的三级转诊中心。目前 MUSC 教师作为 PI 参与了总计 20 项多中心临床试验 或注册管理机构（10 个开放，2 个正在接受 IRB 审查）。该应用程序的PI有 是 20 项研究中 4 项的全国首席研究员。这些协议的范围 从行业赞助的药物或设备试验到 NIH 赞助的药物试验 对于胎儿心脏传导阻滞，请提交至 NIH 前瞻性登记处。师资队伍还 目前运行 11 个本地临床研究方案。参与全部 这些协议得到专门的儿科心脏研究支持的支持 小组由 2 名全职 RN 协调员和一名额外的 RN FTE 组成。合并后的 大量的资源和强大的研究基础设施使 MUSC 的 PI 在 18 个学科中的 6 个中成为排名前 2 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，该提案包含 短期和长期协议。 短期。主肺侧支线圈闭塞的随机试验 在丰坦之前。多种因素影响单一人群的发病率和死亡率 接受 Fontan 手术的心室患者。最近考虑的一项是 APC 的存在。然而多项回顾性研究均未能 明确描述 APC 的作用或其最佳管理。本协议 将前瞻性评估 APC 在术后 Fontan 中的作用 血流动力学和发病率，并确定术前线圈的重要性 栓塞治疗。 长期。胺碘酮与冷却尖端导管消融的随机试验 用于治疗患者复发性房内折返性心动过速 (IART) 患有先天性心脏病。 IART，发病率的最大单一原因 先天性心脏病修复后的晚期，往往会危及生命， 治疗令人沮丧，并且没有明显更好的治疗方法。该协议将 前瞻性地比较最成功的药物和导管疗法 IART。至少 2 年随访期间的主要终点将是 IART 成功消融后或药物负荷和心脏复律后复发。