Augmentation of Limb Perfusion With Contrast Ultrasound
Key facts
- Where
- Portland, United StatesSee the site
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Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 19 and 99 years old?
Source: NCT03195556, who can take part
Where in United States
- OHSUPortland, United StatesContact: Jonathan R Lindner, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Oregon Health and Science University
- Trial code
- NCT03195556
- Record updated
- 23 August 2018
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Hypersensitivity to any ultrasound contrast agent; 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); 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; Known atrial septal defect or large right to left shunt; Hemodynamic instability (hypotension with systolic BP <90 mm Hg, need for vasopressors).