Peripheral Arterial Disease Clinical Trial
Official title:
BRAVO: Biomarker Risk Assessment in Vulnerable Outpatients
The investigators hypothesize that among people with lower extremity peripheral artery
disease (PAD), biomarker levels are higher during time periods immediately preceding an
acute coronary event compared to time periods not immediately preceding an acute coronary
event. Biomarkers the investigators will study are CRP, SAA, and D-dimer. Biomarkers will be
measured at baseline and every two months during follow-up.
The primary aims of this study are as follows. Specific Aim #1. Among participants with PAD
who experience an acute coronary event during follow-up, the investigators will determine
whether biomarker levels measured immediately prior to the coronary event are higher than
levels that do not immediately precede coronary events. Specific Aim #2, Part 1. The
investigators will determine whether participants who experience a coronary event (cases)
have higher biomarker levels at the visit immediately prior to the event than participants
who have not experienced a coronary event (controls) at the time of the case event. Specific
Aim #2, Part 2. The investigators will determine whether participants who experience a
coronary event (cases) have a greater increase in biomarkers during the time period leading
up to the event compared to participants who have not experienced a coronary event
(controls).
To achieve these aims, the investigators will enroll up to 650 participants with PAD and
follow them prospectively, measuring blood samples every two months, and ascertaining the
presence of acute coronary events every two months.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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