NCT03195556

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
12 months until next milestone

Study Start

First participant enrolled

June 18, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

June 16, 2017

Last Update Submit

August 21, 2018

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

  • Change in blood flow at 10 min

    Change in blood flow in calf skeletal muscle

    10 min post-therapeutic ultrasound cavitation.

  • Change in blood flow at 60 min

    Change in blood flow in calf skeletal muscle

    60 min post-therapeutic ultrasound cavitation

Study Arms (2)

Healthy subjects

EXPERIMENTAL

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

Peripheral Artery Disease

EXPERIMENTAL

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

Interventions

UltrasoundDEVICE

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.

Also known as: Contrast ultrasound
Healthy subjectsPeripheral Artery Disease

Eligibility Criteria

Age19 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

RECRUITING

Related Publications (1)

  • 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. 2020 Mar;13(3):641-651. doi: 10.1016/j.jcmg.2019.06.012. Epub 2019 Aug 14.

    PMID: 31422129DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Jonathan R Lindner, MD

CONTACT

5034943574lindnerj@ohsu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 16, 2017

First Posted

June 22, 2017

Study Start

June 18, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

August 23, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)