Augmentation of Limb Perfusion With Contrast Ultrasound
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease. Basic parameters: 19 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Ultrasound
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 measures
- Change in blood flow at 10 min [Time frame: 10 min post-therapeutic ultrasound cavitation.]
- Change in blood flow at 60 min [Time frame: 60 min post-therapeutic ultrasound cavitation]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- OHSU — Portland
Publications
- 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. PMID 31422129
Identifiers
NCT: NCT03195556 · IRB00017343