肾动脉粥样硬化血管重建评估（RAVE研究）：一项随机试验的研究方案 [NCT00127738]
Renal athersosclerotic revascularization evaluation (RAVE study): study protocol of a randomized trial [NCT00127738].
作者信息
Tobe Sheldon W, Atri M, Perkins N, Pugash R, Bell Chaim M
机构信息
Departments of Medicine and Radiology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada.
出版信息
BMC Nephrol. 2007 Jan 26;8:4. doi: 10.1186/1471-2369-8-4.
BACKGROUND
It is uncertain whether patients with renal vascular disease will have renal or mortality benefit from re-establishing renal blood flow with renal revascularization procedures. The RAVE study will compare renal revascularization to medical management for people with atherosclerotic renal vascular disease (ARVD) and the indication for revascularization. Patients will be assessed for the standard nephrology research outcomes of progression to doubling of creatinine, need for dialysis, and death, as well as other cardiovascular outcomes. We will also establish whether the use of a new inexpensive, simple and available ultrasound test, the renal resistance index (RRI), can identify patients with renal vascular disease who will not benefit from renal revascularization procedures1.
METHODS/DESIGN: This single center randomized, parallel group, pilot study comparing renal revascularization with medical therapy alone will help establish an infrastructure and test the feasibility of answering this important question in clinical nephrology. The main outcome will be a composite of death, dialysis and doubling of creatinine. Knowledge from this study will be used to better understand the natural history of patients diagnosed with renal vascular disease in anticipation of a Canadian multicenter trial. Data collected from this study will also inform the Canadian Hypertension Education Program (CHEP) Clinical Practice Guidelines for the management of Renal and Renal Vascular Disease. The expectation is that this program for ARVD, will enable community based programs to implement a comprehensive guidelines based diagnostic and treatment program, help create an evidence based approach for the management of patients with this condition, and possibly reduce or halt the progression of kidney disease in these patients.
DISCUSSION
Results from this study will determine the feasibility of a multicentered study for the management of renovascular disease.
背景
肾血管疾病患者通过肾血管重建术恢复肾血流是否能在肾脏或死亡率方面获益尚不确定。RAVE研究将比较肾血管重建术与药物治疗对动脉粥样硬化性肾血管疾病（ARVD）患者及血管重建术指征的疗效。将对患者进行评估，以观察肌酐翻倍进展、透析需求、死亡等标准肾脏病学研究结果以及其他心血管结局。我们还将确定使用一种新的廉价、简单且可用的超声检查——肾阻力指数（RRI），是否能够识别出无法从肾血管重建术中获益的肾血管疾病患者。
方法/设计：这项单中心随机平行组试点研究比较肾血管重建术与单纯药物治疗，将有助于建立一个基础设施，并测试在临床肾脏病学中回答这个重要问题的可行性。主要结局将是死亡、透析和肌酐翻倍的综合结果。这项研究所得的知识将用于更好地了解被诊断为肾血管疾病患者的自然病程，为加拿大多中心试验做准备。从这项研究中收集的数据也将为加拿大高血压教育计划（CHEP）肾和肾血管疾病管理临床实践指南提供参考。预计这个针对ARVD的项目将使社区项目能够实施基于综合指南的诊断和治疗方案，帮助创建一种基于证据的方法来管理此类患者，并可能减缓或阻止这些患者的肾病进展。
讨论
这项研究的结果将确定一项关于肾血管疾病管理的多中心研究的可行性。
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