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Augmentation of Limb Perfusion With Contrast Ultrasound

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ClinicalTrials.gov Identifier: NCT03195556
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Jonathan R. Lindner, MD, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Ultrasound Not Applicable

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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

Resource links provided by the National Library of Medicine


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.
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




Primary Outcome Measures :
  1. Change in blood flow at 10 min [ Time Frame: 10 min post-therapeutic ultrasound cavitation. ]
    Change in blood flow in calf skeletal muscle

  2. Change in blood flow at 60 min [ Time Frame: 60 min post-therapeutic ultrasound cavitation ]
    Change in blood flow in calf skeletal muscle



Information from the National Library of Medicine

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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
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).

Information from the National Library of Medicine

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


Contacts
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Contact: Jonathan R Lindner, MD 5034943574 lindnerj@ohsu.edu

Locations
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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         
Sponsors and Collaborators
Oregon Health and Science University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jonathan R. Lindner, MD, Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03195556     History of Changes
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

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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
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases