Contrast Ultrasound Perfusion Imaging in PAD With Sonazoid

Phase 2

• Conditions: Peripheral Artery Disease
• Interventions: Drug: Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging)

• Registration Number: NCT02398266
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-03-03
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-25
• Study Start: 2016-08-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-16
• Last Update Posted: 2017-06-19
• Primary Completion: 2018-07-01
• Study Completion: 2018-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

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

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Exclusion Criteria

• Rutherford class 6 or greater
• Allergy to ultrasound contrast agents
• Previous limb amputation
• Pregnancy
• Known congenital or acquired right to left shunt

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with PAD and ABI 0.4-0.6	Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging)	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.
Patients with PAD Undergoing Revascularization	Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging)	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.
Healthy subjects	Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging)	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.

Primary Outcome Measures

Name	Time	Method
Skeletal muscle perfusion as measured by contrast ultrasound with Sonazoid microbubbles	5 minutes

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States