Contrast Ultrasound Perfusion Imaging in PAD With Sonazoid

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Drug: Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging)

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States
      • Recruiting
      • Oregon Health & Science University
      • Contact: Jonathan Lindner, MD; Phone Number: 503-494-8750; Email: lindnerj@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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; Other Names: Sonazoid; Contrast ultrasound microvascular perfusion imaging
Experimental: 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.	Drug: 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; Other Names: Sonazoid; Contrast ultrasound microvascular perfusion imaging
Experimental: 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.	Drug: 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; Other Names: Sonazoid; Contrast ultrasound microvascular perfusion imaging

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: March 3, 2015
• First Submitted That Met QC Criteria: March 24, 2015
• First Posted (Estimate): March 25, 2015

Study Record Updates

• Last Update Posted (Actual): June 19, 2017
• Last Update Submitted That Met QC Criteria: June 16, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: Sonazoid in PAD