Augmentation of Limb Perfusion With Contrast Ultrasound

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

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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).

Contacts and Locations

Contacts

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

Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. 2019 Aug 8. pii: S1936-878X(19)30588-1. doi: 10.1016/j.jcmg.2019.06.012. [Epub ahead of print]

• 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
• 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

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases