Cleveland Clinic Cardiothoracic Collaborative Clinical Center - C6

克利夫兰诊所心胸协作临床中心 - C6

基本信息

批准号：
7471476
负责人：
Eugene Hubert Blackstone
金额：
$ 49.49万
依托单位：
CLEVELAND CLINIC LERNER COM-CWRU
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-07-01 至 2012-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7471476
关键词：
Ablation Americas Aortic Diseases Atrial Fibrillation Cardiac Surgery procedures Cardiovascular Surgical Procedures Cardiovascular system Cessation of life Chronic Clinic Clinical Clinical Research Clinical Trials Complex Coronary Coronary Arteriosclerosis Coronary Artery Bypass Coupled Development Dissection Distal Education Exclusion Fellowship Heart Diseases Hemorrhage Innovative Therapy Intervention Invasive Leadership Lesion Life Mentors NCI Scholars Program Operative Surgical Procedures Patients Pulmonary veins Randomized Controlled Clinical Trials Recording of previous events Recurrence Registries Research Research Personnel Resort Role SECTM1 gene Secure Stroke Surgeon Testing Time abstracting base clinical application concept desire heart rhythm innovation medical specialties multidisciplinary planetary Atmosphere prevent programs skills

项目摘要

DESCRIPTION (provided by applicant): This is a defining moment in the 50-year history of cardiac surgery. For 30+ years, the specialty has been dominated by coronary artery bypass grafting (CABG). Percutaneous coronary intervention has largely replaced CABG as the initial treatment of coronary artery disease, making cardiac surgery a treatment of last resort for patients with complex heart disease. In redefining itself, an atmosphere of innovation abounds, but secure evidence for clinical application of new therapies lags behind enthusiasm. A Network of high-volume Clinical Centers, poised to perform proof-of-concept clinical trials and establish registries, is needed now as never before. Cleveland Clinic, America's highest-volume, highest-ranked cardiovascular surgery program, with the largest clinical research group, possesses the desire, capacity, capability, and track record to participate fully in this Network as a Clinical Center and Clinical Research Skills Development Core. We propose 2 randomized trials of new therapy. One represents the first of several needed steps in testing surgical ablation of permanent atrial fibrillation accompanying structural heart disease in need of surgical intervention. It will test the hypothesis that a more extensive, biatrial lesion set more effectively prevents recurrent atrial fibrillation than simple pulmonary vein isolation. The second tests the hypothesis that newly emerging endovascular exclusion of chronic distal aortic dissection that has undergone aneurysmal degeneration is safer than open surgery. We also propose a clinical research skills development core built on our existing successful Roadmap K12 multidisciplinary scholars program, targeting 1 full-time cardiovascular surgeon-scholar per year for a 2- year education and mentored research fellowship. Lay Summary: The specialty of cardiac surgery needs redirection, with innovation coupled with rigorous multicenter testing of new therapies to be certain of their value. We present 2 randomized trials: 1 tests new treatments for a common heart rhythm disturbance that causes strokes and death, and the other tests a new, less invasive therapy for a disease of the aorta that unexpectedly causes people to bleed to death. We also propose to educate and mentor new surgeon-investigators to take a leadership role in devising ways to build an evidence basis for use of innovative therapies in patients with life-threatening heart disease. (End of Abstract)

描述（由申请人提供）：这是心脏手术50年历史的决定性时刻。 30多年来，该专业一直由冠状动脉搭桥术（CABG）主导。经皮冠状动脉干预已在很大程度上取代了CABG作为冠状动脉疾病的初始治疗，使心脏手术成为患有复杂心脏病患者的最后手段。在重新定义自己的过程中，创新的气氛充斥着，但有证据表明新疗法的临床应用落后于热情。现在从未有过以前的大规模临床中心网络，该网络有望进行概念验证临床试验并建立注册表。克利夫兰诊所（Cleveland Clinic）是美国最多，最高的心血管外科手术计划，其中最大的临床研究小组具有渴望，容量，能力，能力和记录，以充分参与该网络，作为临床中心和临床研究技能发展核心。我们提出了2种新疗法的随机试验。其中一种代表了需要手术干预的结构性心脏病的永久性房颤的手术消融所需步骤中的第一个。它将检验以下假设：比简单的肺静脉分离，更广泛的双重病变套件更有效地防止了复发性心房颤动。第二个检验表明，新出现的内血管内排除的慢性远端主动脉夹层的排除，即进行动脉瘤性变性比开放性手术更安全。我们还建议建立在现有成功的路线图K12多学科学者计划的临床研究技能开发核心计划中，针对1个全职心血管外科医生，每年进行2年的教育，并指导了研究奖学金。摘要：心脏外科手术的特殊性需要重定向，并加上对新疗法的严格多中心测试，以确定其价值。我们提出了2项随机试验：1个测试新的治疗方法，用于导致中风和死亡的常见心律障碍，而其他测试对主动脉疾病进行了一种新的，侵入性的较少疗法，该疾病意外导致人们流血死亡。我们还建议教育和指导新的外科医生评估者在为建立危及生命的心脏病患者中使用创新疗法的证据基础的方法中发挥领导作用。（抽象的结尾）