Contrast Ultrasound Perfusion Imaging in PAD With Sonazoid

Peripheral Artery Disease Clinical Trial

Official title:

Contrast Ultrasound Perfusion Imaging in PAD With Sonazoid

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02398266
• Other study ID #: Sonazoid in PAD
• Status: Recruiting
• Phase: Phase 2
• First received: March 3, 2015
• Last updated: June 16, 2017
• Start date: August 1, 2016
• Est. completion date: July 1, 2018

Study information

• Verified date: June 2017
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The measurement of limb skeletal muscle perfusion and perfusion reserve during exercise is an approach that can assess the total impact of the complex pathophysiologic processes in patients with limb ischemia, particularly in those with diabetes in whom distal arterial disease and abnormal microvascular functional responses are common. This trial is designed to: (a) optimize methods for assessment of limb perfusion at rest and during stress using contrast-enhanced ultrasound (normal subjects) and a microbubble contrast agent that is able to provide non-linear signal without destruction at medium acoustic pressures, and (b) to test whether perfusion imaging provides incremental information on the severity of disease in patients with peripheral artery disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• For Healthy controls: no active major medical problems or vasoactive medications

• For PAD: Known diagnosis with PAD an ABI of 0.4-0.6

Exclusion Criteria:

• Rutherford class 6 or greater

• Allergy to ultrasound contrast agents

• Previous limb amputation

• Pregnancy

• Known congenital or acquired right to left shunt

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Drug:
• Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging)
Skeletal muscle perfusion assessment of the thigh and calf skeletal muscle will be performed with contrast ultrasound of leg muscle with Sonazoid while at rest and during exercise stress

Locations

Country	Name	City	State
United States	Oregon Health & Science University	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	Skeletal muscle perfusion as measured by contrast ultrasound with Sonazoid microbubbles		5 minutes