Claudication: exercise vs endoluminal revascularization (CLEVER) study update.

Claudication: exercise vs endoluminal revascularization (CLEVER) study update.
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跛行:运动与腔内血运重建 (CLEVER) 研究更新。

DOI:
10.1016/j.jvs.2009.04.076
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发表时间:
2009
影响因子:
4.3
通讯作者:
CLEVERInvestigators
CLEVERInvestigators
中科院分区:
医学2区
文献类型:
--
作者:
Murphy,TimothyP;Hirsch,AlanT;Cutlip,DonaldE;Regensteiner,JudithG;Comerota,AnthonyJ;Mohler,Emile;Cohen,DavidJ;Massaro,Joseph;CLEVERInvestigators

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跛行:运动与腔内血运重建 (CLEVER) 研究是一项前瞻性多中心随机临床试验,旨在比较因主动脉瓣关闭不全而导致中重度跛行的队列中使用支架进行的侵入性血运重建与监督运动康复的相对临床和成本效益。该研究目前正在美国和加拿大的 28 个地点进行招募。计划招募 217 名参与者,收集基线、六个月和 18 个月的数据。主要研究终点是分级跑步机测试的最大步行持续时间(MWD);次要终点包括基于社区的步行、心血管疾病风险标记(体重指数、腰围、血压、血脂、葡萄糖耐量和血浆纤维蛋白原)、与健康相关的生活质量和成本效益。目前有六十名随机参与者;招募预计将于 2010 年 7 月结束,最终研究结果将于 2012 年 6 月报告。
The Claudication: Exercise vs Endoluminal Revascularization (CLEVER) Study is a prospective multicenter randomized clinical trial designed to compare the relative clinical and cost-effectiveness of invasive revascularization with stents to supervised exercise rehabilitation in a cohort with moderate to severe claudication due to aortoiliac insufficiency. The study is currently enrolling at twenty-eight sites in the US and Canada. Enrollment of 217 participants is planned, with data collected at baseline, six months, and 18 months. The primary study endpoint is maximum walking duration (MWD) on a graded treadmill test; secondary endpoints include community-based walking, markers of cardiovascular disease risk (body mass index, waist circumference, blood pressure, lipid profile, glucose tolerance, and plasma fibrinogen), health-related quality of life, and cost effectiveness. There are currently sixty randomized participants; recruitment is projected to end in July 2010 and final study results reported in June 2012.