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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with PAD | Patients with PAD who are to undergo surgical or percutaneous revascularization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Patients with atherosclerotic peripheral artery disease scheduled to undergo surgical or percutaneous revascularization.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan R Lindner, MD | Contact | 503 494-9191 | lindnerj@ohsu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU | Recruiting | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |