Actively Recruiting

Phase Not Applicable
Age: 19Years - 99Years
All Genders
Healthy Volunteers
NCT03195556

Augmentation of Limb Perfusion With Contrast Ultrasound

Led by Oregon Health and Science University · Updated on 2018-08-23

30

Participants Needed

1

Research Sites

75 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Augmentation of Limb Perfusion With Contrast Ultrasound

Who Can Participate

Age: 19Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • For PAD patients: confirmed unilateral or bilateral PAD diagnosed by reduced ankle-brachial index or angiography
  • Rutherford symptom class of 4-6 for PAD patients
Not Eligible

You will not qualify if you...

  • Major medical illnesses affecting the limb such as muscle diseases, blood disorders affecting flow or rheology, severe heart failure (NYHA class IV or left ventricular ejection fraction below 30%)
  • Pregnant or lactating females
  • Allergy to any ultrasound contrast agent
  • Known atrial septal defect or large right to left heart shunt
  • Hemodynamic instability including low blood pressure (systolic BP below 90 mm Hg) or need for vasopressors
  • Ongoing myocardial ischemia
  • For normal controls, any known structural non-arrhythmic cardiovascular disease such as coronary artery disease, heart failure, or moderate or greater valve disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

OHSU

Portland, Oregon, United States, 97239

Actively Recruiting

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Research Team

J

Jonathan R Lindner, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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