Actively Recruiting
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
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Augmentation of Limb Perfusion With Contrast Ultrasound
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- For PAD patients: confirmed unilateral or bilateral PAD diagnosed by reduced ankle-brachial index or angiography
- Rutherford symptom class of 4-6 for PAD patients
You will not qualify if you...
- Major medical illnesses affecting the limb such as muscle diseases, blood disorders affecting flow or rheology, severe heart failure (NYHA class IV or left ventricular ejection fraction below 30%)
- Pregnant or lactating females
- Allergy to any ultrasound contrast agent
- Known atrial septal defect or large right to left heart shunt
- Hemodynamic instability including low blood pressure (systolic BP below 90 mm Hg) or need for vasopressors
- 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
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Trial Site Locations
Total: 1 location
1
OHSU
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
J
Jonathan R Lindner, MD
CONTACT
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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