Embolic Protection During Renal Artery Stenting

肾动脉支架置入术期间的栓塞保护

• 批准号: 7906838
• 负责人: MATTHEW S EDWARDS
• 金额: $ 10.94万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-10 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7906838
• 关键词: American; Angioplasty; Area; Arterial Fatty Streak; Balloon Angioplasty; Blood Pressure; Cardiovascular system; Cerebrovascular Circulation; Chronic Kidney Failure; Collaborations; Conduct Clinical Trials; Contrast Media; Coronary; Dependence; Development; Development Plans; Devices; Dialysis procedure; Disease; Distal; Doctor of Medicine; Elderly; End stage renal failure; Event; Fostering; Foundations; Freedom; Glomerular Filtration Rate; Goals; Individual; Inferior; Kidney; Kidney Diseases; Kidney Failure; Lead; Lesion; Medical; Mentored Patient-Oriented Research Career Development Award; Mentorship; Morbidity - disease rate; NIH Program Announcements; National Heart, Lung, and Blood Institute; Nephrotoxic; Operative Surgical Procedures; Outcome; Performance; Population; Positioning Attribute; Procedures; Public Health; Randomized Clinical Trials; Renal Blood Flow; Renal Circulation; Renal function; Research; Research Personnel; Retrieval; Role; Safety; Secondary Hypertension; Secondary to; Testing; Therapeutic Embolization; authority; blood pressure regulation; career; career development; design; experience; functional decline; functional improvement; improved; kidney vascular structure; mortality; particle; patient oriented research; prevent; programs; prospective; public health relevance; renal artery; response

DESCRIPTION (provided by applicant): This is an application for a NHLBI Mentored Patient Oriented Research Career Development Award in response to program announcement PA-00-004. This proposal will foster the scientific development of Dr. Matthew Edwards. The proposed career development plan incorporates a multi-disciplinary program of collaboration and mentorship under the direction of Drs. Kimberley Hansen, Charles McCall, and Robert Byington, internationally recognized authorities in the areas of renovascular disease (RVD), investigator development, and the conduct of clinical trials. This plan is designed to create a focused patient-oriented research experience that will provide the foundation for a successful, independent academic career. RVD is a recognized cause of severe secondary hypertension, progressive renal insufficiency, and endstage renal disease among the elderly who are the fastest growing subsegment of both the general and dialysis dependent populations. Angioplasty and stenting (PTAS) of the renal artery has demonstrated beneficial effects with regard to improving blood pressure control. However, a lower rate of improved renal function has been observed. This limitation is critical as renal function response following renal revascularization has been demonstrated to be a major determinant of subsequent cardiovascular morbidity and mortality as well as dialysis free survival. We hypothesize that the low rate of improved renal function is due to embolization of atheromatous debris liberated during the PTAS procedure. To test this hypothesis we propose a prospective, randomized clinical trial of distal embolic protection device (DEP) use during the performance of renal artery PTAS to maximize the renal function response following the procedure. The specific aims of this project will be 1) to examine the safety and efficacy of DEP to improve renal function and blood pressure response following renal artery PTAS and 2) To characterize the atheromatous debris prevented from passage into the kidney through the use of DEP. The public health relevance of this proposal relates to the improvement of a procedure which may be applicable to millions of Americans with the potential to improve renal function (and by extension subsequent survival free of dialysis dependence and adverse cardiovascular events). Currently, up to 45% of individuals undergoing renal artery PTAS experience inferior renal function results to those observed following surgical revascularization. These inferior results likely lead to inferior survival benefit. Therefore, provision of evidence that DEP improves the outcomes of renal artery PTAS has the potential to alter contemporary medical practice and favorably impact the dialysis-free survival for thousands of individuals each year.

描述（由申请人提供）： 这是 NHLBI 指导的以患者为导向的研究职业发展奖的申请 对计划公告 PA-00-004 的回应。该提案将促进马修·爱德华兹博士的科学发展。拟议的职业发展计划包括在博士的指导下的多学科合作和指导计划。 Kimberley Hansen、Charles McCall 和 Robert Byington 是肾血管疾病 (RVD)、研究者开发和临床试验实施领域的国际公认权威。该计划旨在创造一种以患者为中心的研究体验，为成功、独立的学术生涯奠定基础。 RVD 是老年人中严重继发性高血压、进行性肾功能不全和终末期肾病的公认原因，老年人是普通人群和透析依赖人群中增长最快的群体。肾动脉血管成形术和支架置入术 (PTAS) 已证明对改善血压控制具有有益效果。然而，观察到肾功能改善率较低。这一限制至关重要，因为肾血运重建后的肾功能反应已被证明是随后心血管发病率和死亡率以及无透析生存的主要决定因素。我们推测肾功能改善率低是由于 PTAS 手术期间释放的动脉粥样硬化碎片栓塞所致。为了检验这一假设，我们提出了一项前瞻性、随机临床试验，研究在肾动脉 PTAS 期间使用远端栓塞保护装置 (DEP)，以最大限度地提高术后肾功能反应。该项目的具体目标是 1) 检查 DEP 在肾动脉 PTAS 后改善肾功能和血压反应的安全性和有效性，以及 2) 表征通过使用 DEP 防止动脉粥样硬化碎片进入肾脏。 该提案与公共卫生的相关性涉及改进一种程序，该程序可能适用于数百万美国人，有可能改善肾功能（并通过扩展随后的生存，避免透析依赖和不良心血管事件）。目前，高达 45% 的接受肾动脉 PTAS 的患者的肾功能结果低于手术血运重建后观察到的结果。这些较差的结果可能会导致较差的生存获益。因此，提供 DEP 改善肾动脉 PTAS 结局的证据有可能改变当代的医疗实践，并对每年数千人的免透析生存产生有利影响。

项目成果

A vascular disease educational program in the preclinical years of medical school increases student interest in vascular disease.

医学院临床前阶段的血管疾病教育计划提高了学生对血管疾病的兴趣。

• 发表时间: 2010-09
• 作者: Godshall, Christopher J;Moore, Phillip S;Fleming, Shawn H;Andrews, Jeanette S;Hansen, Kimberley J;Hoyle, John R;Edwards, Matthew S
• 通讯作者: Edwards, Matthew S

Atherosclerotic renovascular disease among hypertensive adults.

成人高血压患者的动脉粥样硬化性肾血管疾病。

• DOI: 10.1016/j.jvs.2009.03.062
• 发表时间: 2009-09
• 期刊: Journal of vascular surgery
• 影响因子: 4.3
• 作者: Davis, Ross P.;Pearce, Jeffrey D.;Craven, Timothy E.;Moore, Phillip S.;Edwards, Matthew S.;Godshall, Christopher J.;Hansen, Kimberley J.
• 通讯作者: Hansen, Kimberley J.

Atheroembolism during percutaneous renal artery revascularization.

经皮肾动脉血运重建期间的动脉粥样硬化栓塞。

• 发表时间: 2007-07
• 影响因子: 4.3
• 作者: Edwards, Matthew S;Corriere, Matthew A;Craven, Timothy E;Pan, Xian Mang;Rapp, Joseph H;Pearce, Jeffrey D;Mertaugh, Nicholas B;Hansen, Kimberley J
• 通讯作者: Hansen, Kimberley J

Is embolic protection during renal artery intervention really necessary?

肾动脉介入治疗中的栓塞保护真的有必要吗？

• 发表时间: 2007-08
• 作者: Corriere, M A;Crutchley, T A;Edwards, M S
• 通讯作者: Edwards, M S

Diastolic function predicts survival after renal revascularization.

舒张功能可预测肾血运重建后的生存率。

• 发表时间: 2011-12
• 作者: Ghanami, Racheed J;Rana, Hamza;Craven, Timothy E;Hoyle, John;Edwards, Matthew S;Hansen, Kimberley J
• 通讯作者: Hansen, Kimberley J