Augmentation of Limb Perfusion With Contrast Ultrasound
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ClinicalTrials.gov Identifier: NCT03195556 |
Recruitment Status : Unknown
Verified August 2018 by Jonathan R. Lindner, MD, Oregon Health and Science University.
Recruitment status was: Recruiting
First Posted : June 22, 2017
Last Update Posted : August 23, 2018
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Condition or disease | Intervention/treatment | Phase |
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Peripheral Arterial Disease | Device: Ultrasound | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Augmentation of Limb Perfusion With Contrast Ultrasound |
Actual Study Start Date : | June 18, 2018 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | December 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Healthy subjects
Low-power contrast ultrasound perfusion imaging and measurement of ABI and TBI will be performed before and after a 15 min high-power ultrasound cavitation therapy with intermittent ultrasound and intravenous infusion of microbubbles.
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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.
Other Name: Contrast ultrasound |
Experimental: Peripheral Artery Disease
Low-power contrast ultrasound perfusion imaging and measurement of ABI and TBI will be performed before and after a 15 min high-power ultrasound cavitation therapy with intermittent ultrasound and intravenous infusion of microbubbles.
|
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.
Other Name: Contrast ultrasound |
- Change in blood flow at 10 min [ Time Frame: 10 min post-therapeutic ultrasound cavitation. ]Change in blood flow in calf skeletal muscle
- Change in blood flow at 60 min [ Time Frame: 60 min post-therapeutic ultrasound cavitation ]Change in blood flow in calf skeletal muscle

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Ages Eligible for Study: | 19 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195556
Contact: Jonathan R Lindner, MD | 5034943574 | lindnerj@ohsu.edu |
United States, Oregon | |
OHSU | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Jonathan R Lindner, MD 503-494-8750 lindnerj@ohsu.edu | |
Principal Investigator: Jonathan R Lindner, MD | |
Sub-Investigator: Brian Davidson, MD |
Responsible Party: | Jonathan R. Lindner, MD, Professor, Oregon Health and Science University |
ClinicalTrials.gov Identifier: | NCT03195556 |
Other Study ID Numbers: |
IRB00017343 |
First Posted: | June 22, 2017 Key Record Dates |
Last Update Posted: | August 23, 2018 |
Last Verified: | August 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Peripheral Arterial Disease Peripheral Vascular Diseases Atherosclerosis Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |