BRAVO: Biomarker Risk Assessment in Vulnerable Outpatients (BRAVO)

Inclusion Criteria:

• Peripheral arterial disease defined as an ABI less than or equal to 0.90 in either leg

We will also include PAD patients with an ABI > 0.90 who meet any of the following criteria:

• History of documented lower extremity revascularization. A written report from the medical record will be required as documentation
• An angiogram demonstrating >50% stenosis in one or more lower extremity arteries. Again, a written report will be required to document this. Participants with an angiogram noting moderate or greater stenosis will also be considered eligible, when a specific amount of stenosis is not denoted
• A report from the non-invasive vascular laboratory demonstrating a toe brachial pressure less than 0.60. Other criteria (i.e. PVR data) from the non-invasive vascular laboratory will not be considered sufficient for inclusion

Exclusion Criteria:

• Treatment for cancer other than non-melanoma skin cancer during the previous 2 years. (However, persons treated for non-invasive breast cancer or prostate cancer during the previous year will be potentially eligible if their physician indicates that their life expectancy is > 24 months, since non-invasive breast and prostate cancer often have an excellent prognosis)
• Unintentional weight loss of > 7.5 pounds in the last six months;
• Mini-Mental Status Exam (MMSE) score < 23 out of 30 or other history of cognitive impairment
• Communication difficulty due to language barriers
• Refusal to have regular blood draws or inability to obtain a blood sample at baseline
• Coronary or cerebrovascular event during the previous six months (these persons may become eligible at a later date)
• History of inflammatory arthritis (rheumatoid arthritis, lupus erythematosis, or polymyalgia rheumatic, gout), however participants with gouty arthritis will be eligible if the last episode was more than three months ago
• Residence more than 40 miles away from the medical center and unwillingness to travel to the medical center for every two month blood collection
• Unable to return for follow up testing for > a consecutive six month period in the next two years
• Heart transplant surgery
• Major surgery (one that required general anesthesia) within the past 3 months These persons may become eligible at a later date