Contrast Ultrasound Assessment of Perfusion Changes After Peripheral Artery Revascularization

Peripheral Artery Disease Clinical Trial

Official title:

Contrast Ultrasound Assessment of Perfusion Changes After Peripheral Artery Revascularization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02877563
• Other study ID #: 16395
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2018
• Source: Oregon Health and Science University
• Contact: Jonathan R Lindner, MD
• Phone: 503 494-9191
• Email: lindnerj[@]ohsu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 99 Years

Eligibility

Inclusion Criteria:

1. History of symptomatic PAD

2. Rutherford score <6

3. Age =18 y.o.

4. Scheduled to undergo surgical or percutaneous revascularization

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Other:
• Contrast ultrasound perfusion imaging of the limb
Contrast enhanced ultrasound imaging at rest and during contractile exercise will be performed prior to revascularization and 3-4 weeks after revascularization.

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
Other	Time to claudication on treadmill exercise test	Time to development of claudication for each leg will be determined on an upright treadmill walking exercise study	1 month
Primary	Skeletal muscle perfusion during exercise stress	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.	1 month
Secondary	Skeletal muscle perfusion at rest.	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.	1 month