Augmentation of Tissue Perfusion in Patients With Peripheral Artery Disease Using Microbubble Cavitation.
O'Neil R Mason, Brian P Davidson, Paul Sheeran...
https://pubmed.ncbi.nlm.nih.gov/31422129Actively Recruiting
Phase Not Applicable
Age: 19Years - 99Years
All Genders
Healthy Volunteers
ID03195556
Augmentation of Limb Perfusion With Contrast Ultrasound
Led by Oregon Health and Science University · Updated on 2018-08-23
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how ultrasound imaging combined with microbubble contrast agents can improve blood flow to the limbs, particularly in people with peripheral artery disease (PAD). Previous studies showed that high power contrast-enhanced ultrasound could nearly double limb perfusion, but those studies focused on imaging rather than treatment. This study aims to measure how much limb blood flow can be increased using specific therapeutic ultrasound settings that remain within FDA-approved safety limits. Participants receive a 15-minute high-power ultrasound therapy with intermittent ultrasound bursts and an intravenous infusion of microbubbles. This treatment is followed by low-power contrast ultrasound imaging to measure blood flow changes. The study includes two groups: healthy subjects and those with PAD. Measurements such as the ankle-brachial index (ABI) and toe-brachial index (TBI) are taken before and after treatment to evaluate perfusion changes. Participants will undergo blood flow assessments at 10 and 60 minutes after the ultrasound therapy to monitor treatment effects. The research team evaluates changes in limb perfusion using ultrasound imaging and clinical measurements. The study is non-randomized and does not involve blinding. Participation involves intravenous microbubble infusion, ultrasound procedures, and clinical assessments to track blood flow improvements over a short period.
CONDITIONS
Brief Title
Augmentation of Limb Perfusion With Contrast Ultrasound
Who Can Participate
Age: 19Years - 99Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- For PAD subjects: known history of unilateral or bilateral peripheral artery disease diagnosed by reduced ankle-brachial index or angiography
- Rutherford symptom class of 4-6 for PAD subjects
You will not qualify if you...
- Major medical illness affecting the limb other than PAD, including muscle disease, blood diseases influencing 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 of ongoing myocardial ischemia
- For normal controls, any known structural non-arrhythmic cardiovascular disease such as coronary artery disease, heart failure, or moderate or greater valve disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 15 minutes
Participants receive high-power ultrasound cavitation therapy with intermittent ultrasound and intravenous infusion of microbubbles to augment limb perfusion.
1 treatment visit (in-person)
Monitoring
Duration - Up to 60 minutes after treatment
Participants have blood flow measurements taken before and after the ultrasound therapy to assess changes in limb perfusion.
1 follow-up visit with assessments at 10 and 60 minutes post-therapy
Trial Site Locations
Total: 1 location
1
OHSU
Portland, Oregon, United States, 97239
Actively Recruiting
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Research Team
J
Jonathan R Lindner, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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