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)是人们日益关注的健康问题 美国人。尤其是，间歇性跛行(IC)影响行走功能和一般生活质量(QOL)，并可预示缺血恶化。近年来，动脉血管成形术和支架置入术在治疗下肢动脉闭塞性疾病中的应用日益增多。然而，临床结果好坏参半，其对患者生活质量的影响很难衡量，特别是对糖尿病患者来说，他们可能会有额外的生物学和功能障碍来获得治疗成功。Louis Nguyen，医学博士，工商管理硕士，哈佛医学院附属布里格姆妇女医院(BWH)血管和内血管外科的外科讲师和外科和公共卫生中心的研究员。这项提案详细说明了一项将阮博士培养成一名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培训和经验， 阮博士打算结合机构的临床研究和国家收集的数据库来研究血管外科中的问题。这项赠款中提出的计划将利用几个哈佛大学机构的教育、研究和职业发展资源。迈克尔·孔特博士(血管外科)、约翰·阿亚尼安博士(医学和哈佛大学公共卫生学院[HSPH])和马克·克里格博士(心血管内科)将组成咨询委员会。乔斯林糖尿病中心的Allison Goldfine博士和HSPH的Myriam Hunink博士将担任顾问。这五人都是各自领域的国际公认的临床医生和研究人员。这项拟议的前瞻性观察队列研究将检验糖尿病、胰岛素抵抗和炎症对腹股沟下经皮外周介入治疗IC结果的影响。第一个目标是使用动脉双功检查血流动力学结果。第二个目的是通过跑步机行走能力和生活质量调查来检查功能结果。第三个目标是将这些发现与成本分析和专门针对糖尿病患者护理的CMS数据库分析结合起来，以检查更大的治疗影响。预计这项研究将有助于更好地了解存在PAD危险因素的糖尿病患者的IC治疗结果。 (摘要结束)

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)