Document Detail


The Claudication: Exercise Vs. Endoluminal Revascularization (CLEVER) study: rationale and methods.
MedLine Citation:
PMID:  18440181     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Intermittent claudication is the primary symptom of peripheral arterial disease, affecting between 1 and 3 million Americans. Symptomatic improvement can be achieved by endovascular revascularization, but such procedures are invasive, expensive, and may be associated with procedural adverse events. Medical treatment options, including claudication medications and supervised exercise training, are also known to be effective, albeit also with associated limitations. The CLEVER (Claudication: Exercise Vs. Endoluminal Revascularization) study, funded by the Heart, Lung, and Blood Institute of the National Institutes of Health, is a prospective, multicenter, randomized, controlled clinical trial evaluating the relative efficacy, safety, and health economic impact of four treatment strategies for people with aortoiliac peripheral arterial disease and claudication. The treatment arms are: (1) optimal medical care (claudication pharmacotherapy); (2) primary stent placement; (3) supervised exercise rehabilitation; and (4) combined stenting with supervised exercise rehabilitation. The CLEVER study is a 5-year randomized, controlled clinical trial to be conducted at approximately 25 centers in the United States that will monitor 252 patients and their responses to treatment during an 18-month follow-up period. The primary end point is change in maximum walking duration on a graded treadmill test. Secondary end points include the change at 18 months in maximum walking duration from baseline, comparisons of free-living daily activity levels assessed by pedometer, health-related quality of life, and cost-effectiveness. Other analyses include the effect of these treatment strategies on anthropomorphic and physiologic variables, including body mass index, waist circumference, blood pressure, pulse pressure, and resting pulse as well as biochemical markers of cardiovascular health, including fasting lipids, fibrinogen, C-reactive protein, and hemoglobin A 1c values.
Authors:
Timothy P Murphy; Alan T Hirsch; John J Ricotta; Donald E Cutlip; Emile Mohler; Judith G Regensteiner; Anthony J Comerota; David J Cohen;
Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2008-04-25
Journal Detail:
Title:  Journal of vascular surgery     Volume:  47     ISSN:  0741-5214     ISO Abbreviation:  J. Vasc. Surg.     Publication Date:  2008 Jun 
Date Detail:
Created Date:  2008-06-02     Completed Date:  2008-07-10     Revised Date:  2013-06-05    
Medline Journal Info:
Nlm Unique ID:  8407742     Medline TA:  J Vasc Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1356-63     Citation Subset:  IM    
Affiliation:
Rhode Island Hospital Vascular Disease Research Center and Brown Medical School Department of Diagnostic Imaging, Providence, RI 02903, USA. tmurphy@lifespan.org
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MeSH Terms
Descriptor/Qualifier:
Activities of Daily Living
Biological Markers / blood
Cardiovascular Agents / economics,  therapeutic use*
Cost-Benefit Analysis
Exercise Therapy* / economics
Humans
Intermittent Claudication / economics,  etiology,  physiopathology,  therapy*
Patient Selection
Peripheral Vascular Diseases / complications,  economics,  physiopathology,  therapy*
Prospective Studies
Quality of Life
Recovery of Function
Research Design
Stents* / economics
Time Factors
Treatment Outcome
United States
Vascular Surgical Procedures / economics,  instrumentation*
Walking
Grant Support
ID/Acronym/Agency:
U01 HL077221/HL/NHLBI NIH HHS; U01 HL077221-03/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:
0/Biological Markers; 0/Cardiovascular Agents
Investigator
Investigator/Affiliation:
Timothy P Murphy / ; Alan T Hirsch / ; John J Ricotta / ; Donald E Cutlip / ; Emile Mohler / ; Judith G Regensteiner / ; Anthony J Comerota / ; David J Cohen / ; Joseph Massaro / ; Beth A Lewis / ; Joselyn Cerezo / ; Michael W Steffes / ; Michael R Jaff / ; George Sopko / ; Suzanne H Goldberg / ; Abby G Ershow / ; Niki U Cotton-Oldenburg /
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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