Contrast Ultrasound Perfusion Imaging in PAD With Sonazoid

NCT02398266 | Unknown Phase 2

• 1 other identifier: Sonazoid in PAD
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Skeletal muscle perfusion as measured by contrast ultrasound with Sonazoid microbubbles

  5 minutes

Study Arms (3)

Healthy subjects

EXPERIMENTAL

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)

Patients with PAD and ABI 0.4-0.6

EXPERIMENTAL

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)

Patients with PAD Undergoing Revascularization

EXPERIMENTAL

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)

Interventions

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

Also known as: Contrast ultrasound microvascular perfusion imaging, Sonazoid

Healthy subjects; Patients with PAD Undergoing Revascularization; Patients with PAD and ABI 0.4-0.6

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For Healthy controls: no active major medical problems or vasoactive medications
• For PAD: Known diagnosis with PAD an ABI of 0.4-0.6

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Sonazoid

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 25, 2015
• Study Start: August 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: June 19, 2017

Record last verified: 2017-06

Locations

US (1)