Back to resultsAugmentation of Limb Perfusion With Contrast Ultrasound
Primary Purpose
Peripheral Arterial Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 y.o.
- For PAD subjects: known history of unilateral or bilateral PAD diagnosed by reduced ankle-brachial index or angiography and a Rutherford symptom class of 4-6.
Exclusion Criteria:
- Major medical illness other than PAD affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure [NYHA class IV or LVEF <30%]).
- Pregnant or lactating females
- Hypersensitivity to any ultrasound contrast agent
- Known atrial septal defect or large right to left shunt.
- Hemodynamic instability (hypotension with systolic BP <90 mm Hg, need for vasopressors)
- Evidence for ongoing myocardial ischemia
- For normal controls, any known structural non-arrhythmic cardiovascular disease (coronary artery disease, heart failure, moderate or greater valve disease).
Sites / Locations
- OHSURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy subjects
Peripheral Artery Disease
Arm Description
Low-power contrast ultrasound perfusion imaging and measurement of ABI and TBI will be performed before and after a 15 min high-power ultrasound cavitation therapy with intermittent ultrasound and intravenous infusion of microbubbles.
Low-power contrast ultrasound perfusion imaging and measurement of ABI and TBI will be performed before and after a 15 min high-power ultrasound cavitation therapy with intermittent ultrasound and intravenous infusion of microbubbles.
Outcomes
Primary Outcome Measures
Change in blood flow at 10 min
Change in blood flow in calf skeletal muscle
Change in blood flow at 60 min
Change in blood flow in calf skeletal muscle
Secondary Outcome Measures
Full Information
NCT ID
NCT03195556
First Posted
June 16, 2017
Last Updated
August 21, 2018
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT03195556
Brief Title
Augmentation of Limb Perfusion With Contrast Ultrasound
Official Title
Augmentation of Limb Perfusion With Contrast Ultrasound
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Our laboratory has discovered that ultrasound (US) imaging together with clinically approved microbubble ultrasound contrast agents can augment limb tissue perfusion. These observations have been made in mice with and without peripheral artery disease (PAD), and also in humans where high power contrast enhanced ultrasound (CEU) was used to measure perfusion but was found also to augment perfusion by almost 2-fold. The latter human studies were performed with ultrasound protocols designed for perfusion imaging and not for flow augmentation. In this study, we will measure the degree to which limb perfusion is augmented with specific therapeutic CEU settings that are still within the FDA-approved limits with regards to US power and contrast dosing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy subjects
Arm Type
Experimental
Arm Description
Low-power contrast ultrasound perfusion imaging and measurement of ABI and TBI will be performed before and after a 15 min high-power ultrasound cavitation therapy with intermittent ultrasound and intravenous infusion of microbubbles.
Arm Title
Peripheral Artery Disease
Arm Type
Experimental
Arm Description
Low-power contrast ultrasound perfusion imaging and measurement of ABI and TBI will be performed before and after a 15 min high-power ultrasound cavitation therapy with intermittent ultrasound and intravenous infusion of microbubbles.
Intervention Type
Device
Intervention Name(s)
Ultrasound
Other Intervention Name(s)
Contrast ultrasound
Intervention Description
Ultrasound exposure of Definity microbubbles infused over 10 min. Ultrasound administered at 1.3 MHz, mechanical index of 1.3, and pulsing interval of 10 s.
Primary Outcome Measure Information:
Title
Change in blood flow at 10 min
Description
Change in blood flow in calf skeletal muscle
Time Frame
10 min post-therapeutic ultrasound cavitation.
Title
Change in blood flow at 60 min
Description
Change in blood flow in calf skeletal muscle
Time Frame
60 min post-therapeutic ultrasound cavitation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥18 y.o.
For PAD subjects: known history of unilateral or bilateral PAD diagnosed by reduced ankle-brachial index or angiography and a Rutherford symptom class of 4-6.
Exclusion Criteria:
Major medical illness other than PAD affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure [NYHA class IV or LVEF <30%]).
Pregnant or lactating females
Hypersensitivity to any ultrasound contrast agent
Known atrial septal defect or large right to left shunt.
Hemodynamic instability (hypotension with systolic BP <90 mm Hg, need for vasopressors)
Evidence for ongoing myocardial ischemia
For normal controls, any known structural non-arrhythmic cardiovascular disease (coronary artery disease, heart failure, moderate or greater valve disease).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan R Lindner, MD
Phone
5034943574
Email
lindnerj@ohsu.edu
Facility Information:
Facility Name
OHSU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan R Lindner, MD
Phone
503-494-8750
Email
lindnerj@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Jonathan R Lindner, MD
First Name & Middle Initial & Last Name & Degree
Brian Davidson, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31422129
Citation
Mason OR, Davidson BP, Sheeran P, Muller M, Hodovan JM, Sutton J, Powers J, Lindner JR. Augmentation of Tissue Perfusion in Patients With Peripheral Artery Disease Using Microbubble Cavitation. JACC Cardiovasc Imaging. 2020 Mar;13(3):641-651. doi: 10.1016/j.jcmg.2019.06.012. Epub 2019 Aug 14.
Results Reference
derived
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Augmentation of Limb Perfusion With Contrast Ultrasound
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