Recruiting

Observational Study

Sponsor:

Oregon Health and Science University

Code:

NCT02877563

Conditions

Peripheral Artery Disease

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

Contrast ultrasound perfusion imaging of the limb

Study Details

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

Study ID

NCT02877563

Start date

Jun 1, 2018

Status verified date

Aug, 2018

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Dec 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with PAD

Patients with PAD who are to undergo surgical or percutaneous 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.

Primary outcome measure

  • Skeletal muscle perfusion during exercise stress [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Jonathan R Lindner, MD

503 494-9191lindnerj@ohsu.edu

Locations

OHSU

Recruiting

Portland, Oregon, United States, 97239

Contacts

Jonathan R Lindner, MD

503-494-8750lindnerj@ohsu.edu

Principal Investigator:

Jonathan R Lindner, MD

More Information

Sponsor

Oregon Health and Science University

Last update posted

Aug 23, 2018

Last verified

Aug, 2018

Keywords

  • peripheral artery disease
  • contrast enhanced ultrasound

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2018-08-23.