Contrast Ultrasound Perfusion Imaging in PAD With Sonazoid

Oregon Health & Science University (OHSU)

Status and phase: Unknown; Phase 2

Conditions: Peripheral Artery Disease

Treatments: Drug: Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging)

Study type: Interventional

Funder types: Other

Identifiers

NCT02398266

Sonazoid in PAD

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

55 participants in 3 patient groups

Healthy subjects

Experimental group

Description:

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.

Treatment:

Drug: Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging)

Patients with PAD and ABI 0.4-0.6

Experimental group

Description:

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.

Treatment:

Drug: Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging)

Patients with PAD Undergoing Revascularization

Experimental group

Description:

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.

Treatment:

Drug: Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging)