Contrast Ultrasound Assessment of Perfusion Changes After Peripheral Artery Revascularization

NCT02877563 | Unknown FDA Drug

• 1 other identifier: 16395
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease

Keywords

peripheral artery disease; contrast enhanced ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Skeletal muscle perfusion at rest.

  1 month

Other Outcomes (1)

• Time to claudication on treadmill exercise test

  1 month

Study Arms (1)

Patients with PAD

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

Other: Contrast ultrasound perfusion imaging of the limb

Interventions

Contrast ultrasound perfusion imaging of the limb OTHER

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

Patients with PAD

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with atherosclerotic peripheral artery disease scheduled to undergo surgical or percutaneous revascularization.

You may qualify if:

• History of symptomatic PAD
• Rutherford score \<6
• Age ≥18 y.o.
• Scheduled to undergo surgical or percutaneous revascularization

You may not qualify if:

• Major medical illness affecting the limb other than PAD (muscle disease, neuromuscular disease, blood diseases).
• Pregnant or lactating females (- HCG in women of child bearing age)
• Hypersensitivity to any ultrasound contrast agent
• 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.
• Allergy to eggs
• Inability to perform modest plantar flexion exercise

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Jonathan R Lindner, MD

CONTACT

503 494-9191; lindnerj@ohsu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 20, 2016
• First Posted: August 24, 2016
• Study Start: June 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)