RECRUITING

Augmentation of Limb Perfusion With Contrast Ultrasound

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Augmentation of Limb Perfusion With Contrast Ultrasound

Quick Facts

Study Start:2018-06-18
Study Completion:2019-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03195556

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥18 y.o.
  2. * 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.
  1. 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. 2. Pregnant or lactating females
  3. 3. Hypersensitivity to any ultrasound contrast agent
  4. 4. Known atrial septal defect or large right to left shunt.
  5. 5. Hemodynamic instability (hypotension with systolic BP \<90 mm Hg, need for vasopressors)
  6. 6. Evidence for ongoing myocardial ischemia
  7. 7. For normal controls, any known structural non-arrhythmic cardiovascular disease (coronary artery disease, heart failure, moderate or greater valve disease).

Contacts and Locations

Study Contact

Jonathan R Lindner, MD
CONTACT
5034943574
lindnerj@ohsu.edu

Study Locations (Sites)

OHSU
Portland, Oregon, 97239
United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-06-18
Study Completion Date2019-12

Study Record Updates

Study Start Date2018-06-18
Study Completion Date2019-12

Terms related to this study

Additional Relevant MeSH Terms

  • Peripheral Arterial Disease