EFFECT OF LIPID MODIFICATION ON PERIPHERAL ARTERIAL DISEASE AFTER ENDOVASCULA

脂质修饰对血管内术后周围动脉疾病的影响

• 批准号: 8356766
• 负责人: CHRISTIE Mitchell BALLANTYNE
• 金额: $ 1.19万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-12-01 至 2011-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8356766
• 关键词: Ankle; Arteries; Atherosclerosis; Blood Tests; Cardiovascular system; Caring; Clinical; Clinical Research; Combined Modality Therapy; Contralateral; Disease; Event; Funding; Grant; High Density Lipoproteins; Image; Imaging technology; Incidence; Inflammation; Leg; Limb structure; Lipids; Lipoproteins; Low-Density Lipoproteins; Magnetic Resonance Imaging; Measurement; Medical; Modification; National Center for Research Resources; Nicotinic Acids; Outcome; Patients; Peripheral arterial disease; Physiologic pulse; Principal Investigator; Quality of life; Questionnaires; Randomized; Recruitment Activity; Research; Research Infrastructure; Resolution; Resources; Source; Stents; Symptoms; Thrombosis; Ultrasonography; United States National Institutes of Health; Walking; claudication; cost; ezetimibe; femoral artery; hemodynamics; pressure; restenosis

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. I. HYPOTHESIS The hypothesis for the study is as follows: Intensive lipid modification with combination therapy will inhibit the progression of atherosclerosis and reduce the incidence of restenosis in femoral arteries following endovascular stenting by decreasing thrombosis and inflammation. II. SPECIFIC AIMS In general, we will recruit a total of 120 patients with symptomatic femoral artery occlusive disease in one leg. These patients will be treated with endovascular stenting, and then randomized into two treatment groups: 1)standard of medical care including statin therapy; and 2) standard of medical care with intensive lipid modification using a statin plus ezetimibe and extended release niacin to increase HDL (40) and decrease LDL (80) and TG (150). Specifically, we will follow these patients for 2 years and study the following specific aims: 1. To determine the effect of intensive lipid modification therapy on progression of atherosclerosis and restenosis of femoral arteries using high resolution MRI image technology to exam both the stented femoral artery for in-stent restenosis and the contralateral fermoral artery for progression of atherosclerosis. 2. To determine the effect of intensive lipid modification therapy on the clinically applicable hemodynamic measurements, clinical symptoms, reduction in systemic major cardiovascular events and the general quality of life of patients following PTA revascularization and stenting by assessment with Duplex ultrasound, segmental limb pressure, segmental pulse volume recording, ankle brachial indicies, treadmill walking distance, absolute claudication and quality of life questionnaires. 3. To determine the effect of intensive lipid modification therapy on lipoproteins, inflammation, and relationship to PAD progression, restenosis, and clinical events. 4. To determine the effect of intensive lipid modification therapy on thrombosis, and relationship to PAD progression, restenosis and clinical events. The association of these blood tests with clinical outcome and femoral artery image will be determined.

该副本是利用资源的众多研究子项目之一 由NIH/NCRR资助的中心赠款提供。对该子弹的主要支持 而且，副投影的主要研究员可能是其他来源提供的 包括其他NIH来源。 列出的总费用可能 代表subproject使用的中心基础架构的估计量， NCRR赠款不直接向子弹或副本人员提供的直接资金。 I.假设 该研究的假设如下：结合疗法的密集脂质修饰将抑制动脉粥样硬化的进展，并通过减少血栓形成和炎症后血管内置于血管内置入后股动脉的再狭窄发生率。 ii。具体目标 通常，我们将在一条腿中招募120例股骨动脉闭塞性疾病的患者。 这些患者将接受血管内支架的治疗，然后随机分为两个治疗组：1）包括他汀类药物治疗的医疗标准； 2）使用他汀类药物加二酰胺和扩展释放烟酸，以增加HDL（40）并降低LDL（80）和TG（150）的医疗保健标准。 具体来说，我们将关注这些患者2年，并研究以下具体目标： 1。使用高分辨率MRI图像技术来确定强化脂质修饰疗法对股动脉的动脉粥样硬化和股动脉再狭窄的影响，以检查股骨支架动脉的内部再狭窄和对侧效费疗法动脉，用于动脉粥样硬化的进展。 2。确定强化脂质修饰疗法对临床适用的血液动力学测量，临床症状，减少，全身主要心血管事件的减少以及PTA血运重建后患者的一般生活质量，并通过用二线超声进行评估和置于pTA的置于pta脉冲，分段的cl脉冲，分段脉冲，分段脉冲，分段脉冲，弯曲指示度，弯管，弯管，弯管，弯管，弯管，弯管，弯管，弯管，弯管，弯管，弯管，弯管，锻炼，弯管，弯管，弯曲， 生活质量问卷。 3。确定密集脂质修饰疗法对脂蛋白，炎症以及与垫进展，再狭窄和临床事件的关系的影响。 4。确定密集脂质修饰疗法对血栓形成的影响以及与垫进展，再狭窄和临床事件的关系。 这些血液检查与临床结果和股动脉图像的关联将得到确定。