Contrast Ultrasound Assessment of Perfusion Changes After Peripheral Artery Revascularization

• Conditions: Peripheral Artery Disease
• Interventions: Other: Contrast ultrasound perfusion imaging of the limb

• Registration Number: NCT02877563
• Lead Sponsor: Oregon Health and Science University

Brief Summary

This study represents an important step to validate the use of contrast-enhanced ultrasound (CEU) as a clinical research tool that can be used as a biologic readout of new therapies for Peripheral Artery Disease (PAD), and as a clinically-reasonable method for assessing impact of revascularization. The primary aim is to establish that CEU limb perfusion imaging can be used to accurately assess therapeutic improvements in tissue perfusion that are linked to symptom improvement.

Detailed Description

The study will be performed in patients with known history of PAD that are scheduled to undergo either surgical or percutaneous revascularization. Limb rest-stress CEU perfusion imaging will be performed before and 3-4 weeks after revascularization. Quantitative measurements of pre-revascularization perfusion, post-revascularization perfusion, and change in perfusion will be compared to symptom status (Rutherford classification and PAD \[Criqui\] questionnaire) at each study point, and to data on time to onset of claudication on an upright treadmill exercise study (Gardiner protocol). Results of angiography will be scored and allow determination of the relationship between angiographic severity of disease and exercise perfusion.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-08-20
• Study First Submitted QC: 2016-08-23
• Study First Posted: 2016-08-24
• Study Start: 2018-06-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-08-23
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. History of symptomatic PAD
2. Rutherford score <6
3. Age ≥18 y.o.
4. Scheduled to undergo surgical or percutaneous revascularization

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Exclusion Criteria

1. Major medical illness affecting the limb other than PAD (muscle disease, neuromuscular disease, blood diseases).
2. Pregnant or lactating females (- HCG in women of child bearing age)
3. Hypersensitivity to any ultrasound contrast agent
4. Evidence right-to-left, bi-directional, or transient cardiac shunt; unexplained pulmonary hypertension (PA systolic pressure >40 mm Hg) or more than moderate reduction in left ventricular systolic function identified on screening echo.
5. Allergy to eggs
6. Inability to perform modest plantar flexion exercise

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with PAD	Contrast ultrasound perfusion imaging of the limb	Patients with PAD who are to undergo surgical or percutaneous revascularization.

Primary Outcome Measures

Name	Time	Method
Skeletal muscle perfusion during exercise stress	1 month	Calf skeletal muscle perfusion will be assessed by contrast-enhanced ultrasound during calf raise exercise (every 3 seconds for 30 seconds). This assessment will be performed before and 3-4 weeks after revascularization.

Secondary Outcome Measures

Name	Time	Method
Skeletal muscle perfusion at rest.	1 month	Calf skeletal muscle perfusion will be assessed by contrast-enhanced ultrasound at rest. This assessment will be performed before and 3-4 weeks after revascularization.

Trial Locations

Locations (1)

OHSU; 🇺🇸 Portland, Oregon, United States