Peripheral Vascular Diseases Clinical Trial
Official title:
Magnetic Resonance in Peripheral Arterial Disease
Peripheral arterial disease (PAD) is a disease in which fatty build-up, or "plaque," accumulates in the peripheral arteries. People with PAD often experience leg pain while walking due to reduced blood flow to the legs. This study will use magnetic resonance imaging (MRI) techniques to examine how specific features of plaque build-up in the leg arteries affect walking ability, leg strength, and balance in people with PAD.
Plaque build-up caused by atherosclerosis increases the risk of blood clots, heart attack,
and stroke. Blockages of plaque can occur in different areas of the body. PAD, a circulatory
disorder in which blockages occur in the peripheral arteries, is one manifestation of
atherosclerosis. Individuals with PAD experience reduced blood flow to the legs, which may
cause leg pain while walking. This study will use MRI techniques to examine how
characteristics of plaque build-up in the leg arteries change over time and how this change
affects function, walking ability, leg strength, and balance in people with PAD. Results
from this study may be used to shape future research studies that will attempt to identify
more effective treatments for people with PAD.
This study will enroll people with PAD, as well as a smaller control group of people who do
not have PAD. At an initial study visit, study researchers will interview participants to
collect information about their medical history, daily activity level, walking ability, and
mental functioning. Blood collection and a leg MRI will occur. Also, blood flow to the legs
will be measured by comparing blood pressure measurements in the arms and legs. Leg function
will be measured through a series of timed walks, leg strength exercises, and muscle power
exercises. Questionnaires to assess participants' medical history will be completed by each
participant's primary care doctor, and study researchers will review participants' medical
records. Participants with knee pain will have a knee x-ray, and participants may wear a
small device called an accelerometer for 1 week to monitor physical activity levels. During
the second and third study visits, occurring at one and two year follow-up, blood flow, leg
function, and leg strength will be measured. If participants cannot attend either study
visit, researchers may visit participants at their home or conduct an interview over the
phone. Study researchers may contact participants by phone once or twice a year for
follow-up.
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Observational Model: Cohort, Time Perspective: Prospective
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