Peripheral Artery Disease
Conditions
Keywords
peripheral artery disease, contrast enhanced ultrasound
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.
Interventions
OTHERContrast 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.
Sponsors
Oregon Health and Science University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to claudication on treadmill exercise test | 1 month | Time to development of claudication for each leg will be determined on an upright treadmill walking exercise study |
Countries
United States
Contacts
Primary ContactJonathan R Lindner, MD
Outcome results
None listed