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NCT Number: NCT03195556

Augmentation of Limb Perfusion With Contrast Ultrasound

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.

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Key information

Conditions

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

Age range

19 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OHSU

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Brian Davidson, MD

SUB_INVESTIGATOR

Jonathan R Lindner, MD

CONTACT

[email protected]

503-494-8750

Jonathan R Lindner, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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).

Treatment and study plan

Ultrasound

Device

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 names: Contrast ultrasound

Primary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan R Lindner, MD

CONTACT

[email protected]

5034943574

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 22, 2017
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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