Augmentation of Limb Perfusion With Contrast Ultrasound

Peripheral Arterial Disease Clinical Trial

Official title:

Augmentation of Limb Perfusion With Contrast Ultrasound

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03195556
• Other study ID #: IRB00017343
• Status: Recruiting
• Phase: N/A
• Start date: June 18, 2018
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: Oregon Health and Science University
• Contact: Jonathan R Lindner, MD
• Phone: 5034943574
• Email: lindnerj[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 99 Years

Eligibility

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).

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	OHSU	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood flow at 10 min	Change in blood flow in calf skeletal muscle	10 min post-therapeutic ultrasound cavitation.
Primary	Change in blood flow at 60 min	Change in blood flow in calf skeletal muscle	60 min post-therapeutic ultrasound cavitation