Peripheral Artery Disease
Conditions
Brief summary
The measurement of limb skeletal muscle perfusion and perfusion reserve during exercise is an approach that can assess the total impact of the complex pathophysiologic processes in patients with limb ischemia, particularly in those with diabetes in whom distal arterial disease and abnormal microvascular functional responses are common. This trial is designed to: (a) optimize methods for assessment of limb perfusion at rest and during stress using contrast-enhanced ultrasound (normal subjects) and a microbubble contrast agent that is able to provide non-linear signal without destruction at medium acoustic pressures, and (b) to test whether perfusion imaging provides incremental information on the severity of disease in patients with peripheral artery disease.
Interventions
DRUGContrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging)
Skeletal muscle perfusion assessment of the thigh and calf skeletal muscle will be performed with contrast ultrasound of leg muscle with Sonazoid while at rest and during exercise stress
Sponsors
Oregon Health and Science University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* For Healthy controls: no active major medical problems or vasoactive medications * For PAD: Known diagnosis with PAD an ABI of 0.4-0.6
Exclusion criteria
* Rutherford class 6 or greater * Allergy to ultrasound contrast agents * Previous limb amputation * Pregnancy * Known congenital or acquired right to left shunt
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skeletal muscle perfusion as measured by contrast ultrasound with Sonazoid microbubbles | 5 minutes |
Countries
United States
Outcome results
None listed