NCT03195556 Augmentation of Limb Perfusion With Contrast Ultrasound
| NCT ID | NCT03195556 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oregon Health and Science University |
| Condition | Peripheral Arterial Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2018-06-18 |
| Primary Completion | 2019-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2018-06-18 with a primary completion date of 2019-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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: 1. Major medical illness other than PAD affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure \[NYHA class IV or LVEF \<30%\]). 2. Pregnant or lactating females 3. Hypersensitivity to any ultrasound contrast agent 4. Known atrial septal defect or large right to left shunt. 5. Hemodynamic instability (hypotension with systolic BP \<90 mm Hg, need for vasopressors) 6. Evidence for ongoing myocardial ischemia 7. For normal controls, any known structural non-arrhythmic cardiovascular disease (coronary artery disease, heart failure, moderate or greater valve disease).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03195556 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 99 Years, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03195556 currently recruiting?
Yes, NCT03195556 is actively recruiting participants. Contact the research team at lindnerj@ohsu.edu for enrollment information.
Where is the NCT03195556 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT03195556 clinical trial?
NCT03195556 is sponsored by Oregon Health and Science University. The trial plans to enroll 30 participants.