Percutaneous Treatment of Claudication: The Role of Diabetes and Inflammation

描述（由申请人提供）： 糖尿病（DM）和外周动脉疾病（PAD）是快速增长的健康问题， 美国人特别是，间歇性跛行（IC）影响步行功能，一般生活质量（QOL），并可能预示着缺血恶化。近年来，动脉血管成形术和支架置入术治疗下肢动脉闭塞性疾病的应用越来越多。然而，临床结局喜忧参半，其对患者QOL的影响难以衡量，尤其是对于可能存在其他生物学和功能障碍影响治疗成功的DM患者。 Louis Nguyen，医学博士，工商管理硕士，是布莱根妇女医院（BWH）血管和血管内手术部的外科讲师，也是外科和公共卫生中心的研究员，布莱根妇女医院是哈佛医学院的教学附属机构。该提案详细说明了将Nguyen博士培养为独立临床研究人员的计划。由于他在外科和卫生服务研究方面的独特训练和经验， 博士Nguyen打算通过使用基于机构的临床研究与全国收集的数据库相结合来研究血管外科中的问题。该计划将利用哈佛大学几个机构的教育、研究和职业发展资源。Michael Conte博士（血管外科）、John Ayanian博士（医学和哈佛公共卫生学院[HSPH]）和Mark Creager博士（心血管医学）将组成咨询委员会。Allison Goldfine博士（Joslin糖尿病中心）和Myriam Hunink博士（HSPH）将担任顾问。这五位都是各自领域国际公认的临床研究人员。 拟定的前瞻性观察性队列研究将检查DM、胰岛素抵抗和炎症对腹股沟下经皮外周介入治疗IC结局的影响。第一个目的是使用动脉多普勒检查血流动力学结局。第二个目标是使用跑步机行走性能和QOL调查检查功能结果。第三个目标结合这些研究结果，以检查更大的治疗影响与成本分析和CMS数据库分析具体到糖尿病患者的护理。预计这项研究将有助于更好地了解有PAD风险因素的DM患者IC治疗结局的临床和经济学意义。 (End摘要）

DESCRIPTION (provided by applicant): Diabetes (DM) and peripheral artery disease (PAD) are rapidly growing health concerns among Americans. In particular, intermittent claudicatiori (IC) affects walking function, general quality of life (QOL), and can herald worsening ischemia. The use of arterial angioplasty and stenting to treat lower extremity arterial occlusive disease has increased recently. However, clinical outcomes have been mixed and their impact on patient QOL difficult to measure, especially for patients with DM who may have additional biological and functional obstacles to treatment success. Louis Nguyen, MD, MBA, is Instructor of Surgery in the Division of Vascular & Endovascular Surgery and Investigator in the Center for Surgery and Public Health at Brigham & Women's Hospital (BWH), a teaching affiliate of Harvard Medical School. This proposal details a plan to develop Dr. Nguyen into an independent clinical researcher. Because of his unique training and experience in surgery and health services research, Dr. Nguyen intends to study problems in vascular surgery by using a combination of institutionally-based clinical studies with nationally collected databases. The plan proposed in this grant will capitalize on the educational, research, and career development resources of several Harvard University institutions. Drs. Michael Conte (Vascular Surgery), John Ayanian (Medicine and Harvard School of Public Health [HSPH]), and Mark Creager (Cardiovascular Medicine) will comprise the Advisory Committee. Drs. Allison Goldfine (Joslin Diabetes Center) and Myriam Hunink (HSPH) will serve as consultants. All five are internationally recognized clinician-researchers in their fields. The proposed prospective observational cohort study will examine the effects of DM, insulin resistance, and inflammation on outcomes of infrainguinal percutaneous peripheral interventions for IC. The first aim examines hemodynamic outcomes using arterial duplex. The second aim examines functional outcomes using treadmill walking performance and QOL surveys. The third aim combines these findings to examine larger treatment implications with a cost analysis and CMS database analysis specific to the care of DM patients. It is anticipated that this research will contribute to the better clinical and economic understanding of IC treatment outcomes for DM patients with PAD risk factors. (End of Abstract)