Contrast Ultrasound Perfusion Imaging in PAD With Sonazoid

NCT ID: NCT02398266

Last Updated: 2017-06-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-01
• Study Completion Date: 2018-07-01

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.

Conditions

Peripheral Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healthy subjects

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Patients with PAD and ABI 0.4-0.6

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Patients with PAD Undergoing Revascularization

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

Contrast 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

Intervention Type: DRUG

Other Intervention Names

Contrast ultrasound microvascular perfusion imaging; Sonazoid

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Jonathan R. Lindner, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oregon Health & Science University

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Jonathan Lindner, MD

Role: primary

lindnerj@ohsu.edu

503-494-8750

Other Identifiers

Sonazoid in PAD

Identifier Type: -

Identifier Source: org_study_id