Claudication Exercise vs Endoluminal Revascularization

跛行运动与腔内血运重建术

• 批准号: 8470026
• 负责人: Donald Cutlip
• 金额: $ 27.17万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-15 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8470026
• 关键词: Activities of Daily Living; Adverse event; Age; Atherosclerosis; Biochemical; Blinded; Blood Pressure; Boston; C-reactive protein; Cardiovascular system; Case Report Form; Chronic; Chronic Disease; Clinical; Clinical Research; Clinical Trials Data Monitoring Committees; Conduct Clinical Trials; Costs and Benefits; Data; Data Coordinating Center; Databases; Demographic Analyses; Development; Doctor of Philosophy; Elderly; Event; Exercise; Fibrinogen; Generations; Health; Individual; Instruction; Intermittent Claudication; Investigation; Laboratories; Lipids; Living Costs; Maintenance; Medical; Metric; Morbidity - disease rate; Multi-Institutional Clinical Trial; Patients; Perceived quality of life; Peripheral arterial disease; Pharmacotherapy; Physical Function; Physical activity; Physical therapy exercises; Population; Prevalence; Process; Protocols documentation; Quality of life; Rehabilitation therapy; Relative (related person); Reporting; Research; Research Institute; Risk Factors; Role; Safety; Services; Site; Stents; Testing; Walking; adjudicate; adjudication; artery occlusion; cardiovascular disorder risk; claudication; cost effectiveness; data management; design; economic impact; electronic data; experience; health economics; improved; prospective; treatment as usual; treatment strategy

DESCRIPTION (provided by applicant): Intermittent claudication is common in older individuals and often substantially limits physical activity. Physical activity levels in the elderly strongly predict cardiovascular and other morbidity. Despite claudication's prevalence, there remains controversy regarding the roles of revascularization and exercise therapy to improve physical functioning. The BROAD, LONG-TERM OBJECTIVE of the proposal is to optimize physical functioning, increase activity levels, and reduce cardiovascular disease risk in older individuals with peripheral arterial disease. The SPECIFIC AIM of the proposed trial is to test the primary hypothesis that aortoiliac stenting/pharmacotherapy improves maximum walking duration (MWD) better than supervised exercise rehabilitation/exercise maintenance/pharmacotherapy for those with aortoiliac artery obstruction at 6 months. Other aims are to compare these two treatment groups with a third group, usual care/pharmacotherapy, at 6 months, and to compare all 3 groups with regard to the following variables: MWD change score at 18 months, changes in free-living daily activity levels, patient-perceived quality of life, and cost-effectiveness. We also will perform exploratory analyses of demographic and biochemical risk factors for atherosclerosis, including BMI, blood pressure, lipid profile, HgbAlc, fibrinogen, and C-reactive protein. The HEALTH-RELATEDNESS of this project is that claudication is common in older individuals, will increase in prevalence as our population ages, is chronic, and disabling. It limits physical activity and thereby increases cardiovascular disease risk. Optimum therapy is controversial, and varies by region and practitioner. The RESEARCH DESIGN AND METHODS is to divide 246 patients (at 9 study sites) with aortoiliac insufficiency and intermittent claudication randomly into 3 groups: usual care/pharmacotherapy, exercise rehabilitation/maintenance/pharmacotherapy, and stent/pharmacotherapy. Recruitment will be done over 28 months and patients will be followed for 18 months; the total study duration will be 5 years.

描述（由申请人提供）： 间歇性的lau不平是老年人常见的，通常会大大限制体育锻炼。 老年人的体育活动水平强烈预测心血管和其他发病率。尽管有克劳的流行，但关于血运重建和运动疗法改善身体机能的作用仍然存在争议。该提案的广泛，长期目标是优化身体功能，提高活动水平并降低外周动脉疾病老年人的心血管疾病风险。拟议试验的具体目的是检验主要假设，即比监督的运动康复/锻炼/运动维护/药物治疗更好地提高了主动脉治治/药物治疗的最大步行持续时间（MWD），为6个月的主动脉动脉梗阻患者。其他目的是将这两个治疗组与第三组（通常为6个月）进行比较，并在6个月（在以下变量中进行比较）进行比较：MWD变化分数在18个月时的变化评分，自由生活的日常活动水平的变化，患者感知的生活质量的生活质量和成本效益。我们还将对动脉粥样硬化的人口统计学和生化危险因素进行探索性分析，包括BMI，血压，脂质谱，HGBALC，纤维蛋白原和C反应蛋白。该项目与健康相关的是，lau不休在老年人中很常见，随着我们的人口年龄的年龄，慢性病和残疾，患病率会增加。它限制了体育锻炼，从而增加了心血管疾病的风险。最佳治疗是有争议的，并且因地区和从业者而异。研究设计和方法是将246名患者（在9个研究地点）分为主动脉症不足和间歇性lau不平，将其随机分为3组：通常的护理/药物治疗，运动康复/维护/维护/药物治疗以及支架/药物治疗。招募将在28个月内完成，并将遵循18个月的患者；总学习持续时间为5年。

项目成果

Supervised exercise versus primary stenting for claudication resulting from aortoiliac peripheral artery disease: six-month outcomes from the claudication: exercise versus endoluminal revascularization (CLEVER) study.

• DOI: 10.1161/circulationaha.111.075770
• 发表时间: 2012-01-03
• 期刊: Circulation
• 影响因子: 37.8
• 作者: Murphy TP;Cutlip DE;Regensteiner JG;Mohler ER;Cohen DJ;Reynolds MR;Massaro JM;Lewis BA;Cerezo J;Oldenburg NC;Thum CC;Goldberg S;Jaff MR;Steffes MW;Comerota AJ;Ehrman J;Treat-Jacobson D;Walsh ME;Collins T;Badenhop DT;Bronas U;Hirsch AT;CLEVER Study Investigators
• 通讯作者: CLEVER Study Investigators

The effect of gender on outcomes of aortoiliac artery interventions for claudication.

性别对主动脉髂动脉跛行干预结果的影响。

• DOI: 10.1016/j.clinimag.2015.09.003
• 发表时间: 2016
• 期刊: Clinical imaging
• 影响因子: 2.1
• 作者: Krishnamurthy,VenkataramuN;Naeem,Muhammad;Murphy,TimothyP;Cerezo,Joselyn;Jordan,PaulGaither;Goldberg,SuzanneH;Ershow,AbbyG;Hirsch,AlanT;Oldenburg,Niki;Cutlip,DonaldE
• 通讯作者: Cutlip,DonaldE

Correlation of patient-reported symptom outcomes and treadmill test outcomes after treatment for aortoiliac claudication.

• DOI: 10.1016/j.jvir.2013.05.057
• 发表时间: 2013-10
• 期刊: Journal of vascular and interventional radiology : JVIR
• 作者: Murphy TP;Reynolds MR;Cohen DJ;Regensteiner JG;Massaro JM;Cutlip DE;Mohler ER;Cerezo J;Oldenburg NC;Thum CC;Goldberg S;Hirsch AT
• 通讯作者: Hirsch AT

Cost-effectiveness of supervised exercise, stenting, and optimal medical care for claudication: results from the Claudication: Exercise Versus Endoluminal Revascularization (CLEVER) trial.

监督运动、支架植入和跛行最佳医疗护理的成本效益：来自跛行：运动与腔内血运重建 (CLEVER) 试验的结果。

• DOI: 10.1161/jaha.114.001233
• 发表时间: 2014
• 期刊: Journal of the American Heart Association
• 影响因子: 5.4
• 作者: Reynolds,MatthewR;Apruzzese,Patricia;Galper,BenjaminZ;Murphy,TimothyP;Hirsch,AlanT;Cutlip,DonaldE;Mohler3rd,EmileR;Regensteiner,JudithG;Cohen,DavidJ
• 通讯作者: Cohen,DavidJ