EFFECT OF LIPID MODIFICATION ON PERIPHERAL ARTERIAL DISEASE AFTER ENDOVASCULA
EFFECT OF LIPID MODIFICATION ON PERIPHERAL ARTERIAL DISEASE AFTER ENDOVASCULA
批准号:
8166761
负责人:
CHRISTIE Mitchell BALLANTYNE
金额:
$2.17万
依托单位国家:
美国
项目类别:
财政年份:
2009
资助国家:
美国
项目状态:
已结题
起止时间:
2009-12-01 至 2010-11-30
关键词:
AnkleArteriesAtherosclerosisBlood TestsCardiovascular systemCaringClinicalCombined Modality TherapyComputer Retrieval of Information on Scientific Projects DatabaseContralateralDiseaseEventFundingGrantHigh Density LipoproteinsImageImaging technologyIncidenceInflammationInstitutionLegLimb structureLipidsLipoproteinsLow-Density LipoproteinsMagnetic Resonance ImagingMeasurementMedicalModificationNicotinic AcidsOutcomePatientsPeripheral arterial diseasePhysiologic pulseQuality of lifeQuestionnairesRandomizedRecruitment ActivityResearchResearch PersonnelResolutionResourcesSourceStentsSymptomsThrombosisUltrasonographyUnited States National Institutes of HealthWalkingclaudicationezetimibefemoral arteryhemodynamicspressurerestenosis
中文摘要
这个子项目是许多研究子项目中的一个
由NIH/NCRR资助的中心赠款提供的资源。子项目和
研究者(PI)可能从另一个NIH来源获得主要资金,
因此可以在其他CRISP条目中表示。列出的机构是
研究中心,而研究中心不一定是研究者所在的机构。
本研究的假设如下:强化脂质修饰与联合治疗将通过减少血栓形成和炎症来抑制动脉粥样硬化的进展,并降低血管内支架植入术后股动脉再狭窄的发生率。
总体而言,我们将招募120例单侧下肢有症状性股动脉闭塞性疾病的患者。 这些患者将接受血管内支架植入术治疗,然后随机分为两个治疗组:1)标准医疗护理,包括他汀类药物治疗;和2)标准医疗护理,使用他汀类药物加依折麦布和缓释烟酸进行强化脂质修饰,以增加HDL(> 40)并降低LDL(<80)和TG(<150)。 具体而言,我们将对这些患者进行为期2年的随访,并研究以下具体目标:
1. 使用高分辨率MRI成像技术检查支架置入股动脉的支架内再狭窄和对侧股动脉的动脉粥样硬化进展,以确定强化脂质修饰治疗对动脉粥样硬化进展和股动脉再狭窄的影响。
2.通过双功超声、节段性肢体压力、节段性脉搏容积记录、踝肱指数、踏车行走距离、绝对跛行和
生活质量问卷。
3.确定强化脂质修饰治疗对脂蛋白、炎症的影响以及与PAD进展、再狭窄和临床事件的关系。
4.确定强化脂质修饰治疗对血栓形成的影响,以及与PAD进展、再狭窄和临床事件的关系。 将确定这些血液检查与临床结局和股动脉影像的相关性。
英文摘要
This subproject is one of many research subprojects utilizing the
resources provided by a Center grant funded by NIH/NCRR. The subproject and
investigator (PI) may have received primary funding from another NIH source,
and thus could be represented in other CRISP entries. The institution listed is
for the Center, which is not necessarily the institution for the investigator.
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.
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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