BRAVO: Biomarker Risk Assessment in Vulnerable Outpatients

Recruitment & Eligibility

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

Study & Design

Primary Outcome Measures

Name	Time	Method
fatal and non-fatal coronary events	Every two months for up to three and a half years	Our primary outcome is fatal and non-fatal coronary events. Non-fatal coronary events will be defined as acute myocardial infarction (MI), hospitalizations for unstable angina, and new ECG findings consistent with MI

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (6)

Northwestern University Feinberg School of Medicine

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