Back to resultsContrast Ultrasound Perfusion Imaging in PAD With Sonazoid
Primary Purpose
Peripheral Artery Disease
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging)
Sponsored by
About this trial
This is an interventional diagnostic trial for Peripheral Artery Disease
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
Sites / Locations
- Oregon Health & Science UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Healthy subjects
Patients with PAD and ABI 0.4-0.6
Patients with PAD Undergoing Revascularization
Arm 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.
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.
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.
Outcomes
Primary Outcome Measures
Skeletal muscle perfusion as measured by contrast ultrasound with Sonazoid microbubbles
Secondary Outcome Measures
Full Information
NCT ID
NCT02398266
First Posted
March 3, 2015
Last Updated
June 16, 2017
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT02398266
Brief Title
Contrast Ultrasound Perfusion Imaging in PAD With Sonazoid
Official Title
Contrast Ultrasound Perfusion Imaging in PAD With Sonazoid
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
July 1, 2018 (Anticipated)
Study Completion Date
July 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy subjects
Arm Type
Experimental
Arm 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.
Arm Title
Patients with PAD and ABI 0.4-0.6
Arm Type
Experimental
Arm 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.
Arm Title
Patients with PAD Undergoing Revascularization
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging)
Other Intervention Name(s)
Contrast ultrasound microvascular perfusion imaging, Sonazoid
Intervention Description
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
Primary Outcome Measure Information:
Title
Skeletal muscle perfusion as measured by contrast ultrasound with Sonazoid microbubbles
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Lindner, MD
Phone
503-494-8750
Email
lindnerj@ohsu.edu
12. IPD Sharing Statement
Learn more about this trial
Contrast Ultrasound Perfusion Imaging in PAD With Sonazoid
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