Augmentation of Limb Perfusion With Contrast Ultrasound

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT03195556
Status
Recruiting
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Conditions

  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
19 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Ultrasound — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jun 18, 2018
Status verified
Aug 2018
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in blood flow at 10 min [ Time Frame: 10 min post-therapeutic ultrasound cavitation. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OHSUPortlandOregon97239
Jonathan R Lindner, MD
[email protected]
503-494-8750
Jonathan R Lindner, MD (PRINCIPAL_INVESTIGATOR)
Brian Davidson, MD (SUB_INVESTIGATOR)

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