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.

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