Contrast Ultrasound Perfusion Imaging in PAD With Sonazoid

Study Overview
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Brief Summary
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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.

Official Title
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Contrast Ultrasound Perfusion Imaging in PAD With Sonazoid

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Drug: Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy subjects<br>Intervention: administration of ultrasound contrast agent (drug) to assess muscle perfusion. Normal healthy subjects (n=10) will be used for optimization of dose and acoustic settings for performing real-time contrast ultrasound perfusion imaging of the limb. | Drug: Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging)<br>* 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<br>* Other names: Sonazoid;|
| Experimental: Patients with PAD and ABI 0.4-0.6<br>Intervention: administration of ultrasound contrast agent (drug) to assess muscle perfusion. Patients with moderate to severe PAD (ABI 0.4 to 0.6) will be evaluated with contrast ultrasound perfusion imaging using methods optimized in the first Arm to determine whether symptoms better correlate with perfusion imaging than other measures of PAD severity. | Drug: Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging)<br>* 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<br>* Other names: Sonazoid;|
| Experimental: Patients with PAD Undergoing Revascularization<br>Intervention: administration of ultrasound contrast agent (drug) to assess change in muscle perfusion produced by revascularization (surgical or percutaneous procedure). Patients with symptomatic PAD will be evaluated with contrast ultrasound perfusion imaging using methods optimized in the first Arm before and within 1 month of revascularization to determine whether improvement in symptoms correlate with perfusion imaging data. | Drug: Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging)<br>* 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<br>* Other names: Sonazoid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal muscle perfusion as measured by contrast ultrasound with Sonazoid microbubbles |  | 5 minutes |