Contrast Ultrasound Assessment of Perfusion Changes After Peripheral Artery Revascularization

NCT ID: NCT02877563

Last Updated: 2018-08-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2019-12-31

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.

Conditions

Peripheral Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with PAD

Patients with PAD who are to undergo surgical or percutaneous revascularization.

Contrast ultrasound perfusion imaging of the limb

Intervention Type: OTHER

Contrast enhanced ultrasound imaging at rest and during contractile exercise will be performed prior to revascularization and 3-4 weeks after revascularization.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Jonathan R. Lindner, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

OHSU

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jonathan R Lindner, MD

Role: CONTACT

lindnerj@ohsu.edu

503 494-9191

Facility Contacts

Jonathan R Lindner, MD

Role: primary

lindnerj@ohsu.edu

503-494-8750

Other Identifiers

16395

Identifier Type: -

Identifier Source: org_study_id