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Tracking Information | |||||
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First Received Date † | September 27, 2007 | ||||
Last Updated Date | May 19, 2008 | ||||
Start Date † | September 2006 | ||||
Current Primary Outcome Measures † |
walking time [ Time Frame: 24 months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00537225 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
quality of life, biomarkers of CVD risk, endothelial function [ Time Frame: 24 months ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Multifactor Risk Reduction for Optimal Management of PAD | ||||
Official Title † | Multifactor Risk Reduction for Optimal Management of PAD | ||||
Brief Summary | Patients with peripheral arterial disease (PAD) experience significant functional limitations due to ischemic symptoms (claudication) and are at high risk for CVD morbidity and mortality resulting from untreated cardiovascular disease (CVD) risk factors and aggressive atherosclerosis. The overall Goal of this randomized controlled clinical trial is to examine the synergistic effect of a multifactor risk reduction on walking distance, blood flow and quality of life in 300 patients with PAD. Specifically, we will compare the effects of 24 months of a novel, yet well-tested multiple risk factor reduction program, the Health Education and Risk Reduction Training (HEAR2T) Program for PAD versus enhanced standard care on: 1) symptom limited walking distance as assessed by treadmill exercise testing and walking impairment questionnaire; 2) endothelial function as measured by flow mediated vasodilation (FMVD) via brachial artery ultrasound. We will also explore the association between FMVD and decreased oxidative stress (as measured by oxygen radical absorbance capacity and urinary isoprostanes) and reduced degradation of nitric oxide (NO) and/or increased NO biosynthesis (as measured by urine nitrogen oxide, plasma nitrogen oxide, plasma asymmetric dimethylarginine, plasma, urine and platelet cyclic GMP). Secondary hypotheses examine the association between reducing CVD risk factors, improved endothelial function, increased walking distance, improved quality of life and number of metabolic syndrome abnormalities in PAD patients. Significance. This study will contribute to evidence on the efficacy of multiple risk factor reduction on improving physical function and quality of life in the understudied, elderly PAD patient. This study will also provide preliminary evidence for the biological basis for the efficacy of multifactor risk reduction in restoring vascular homeostasis, critical because of its role in antiatherogenesis and maintaining vasoreactivity, both necessary for slowing the progression of atherosclerosis. |
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Detailed Description | |||||
Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment | ||||
Condition † | Peripheral Arterial Disease | ||||
Intervention † | Behavioral: case management | ||||
Study Arms / Comparison Groups | Placebo Comparator: enhanced usual care | ||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 300 | ||||
Estimated Completion Date | June 2011 | ||||
Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria: Subjects eligible for this study include:
Exclusion Criteria: Exclusion criteria include:
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Gender | Both | ||||
Ages | 50 Years to 90 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00537225 | ||||
Responsible Party | Joan Kaiser, UCSF | ||||
Secondary IDs †† | NIH 5RO1NR9197-2 | ||||
Study Sponsor † | University of California, San Francisco | ||||
Collaborators †† |
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Investigators † |
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Information Provided By | University of California, San Francisco | ||||
Verification Date | September 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |