Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL174785-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to develop a new noninvasive tool for early diagnosis of Peripheral Arterial Disease (PAD) and use the proposed method for monitoring the disease progression and the response to interventional treatment in PAD patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | Symptomatic patients with claudication, at risk for peripheral arterial disease (PAD) |
|
| Healthy Volunteers | Experimental | Healthy volunteers with normal ankle-brachial index (ABI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Imaging | Diagnostic Test | Non-invasive ultrasound will be performed using Angio Flow Reactivity Analysis (AFRA) The ultrasound probe will be attached to the subject's calf muscle and a pressure cuff will be secured around thigh. Ultrasound data will be collected for 1 minute. The cuff will then be induced to a tolerable pressure of no more than 160 mm Hg, and ultrasound data will be collected for 3 minutes while cuff is inflated. The cuff pressure will be released, and ultrasound data will be collected for 2 minutes after the release. Subject will be asked to perform 1 minute plantar flexion exercise, and ultrasound data will be collected for two minutes after the completion of exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of peripheral arterial disease using ultrasound perfusion estimation | Evaluate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ultrasound perfusion estimation compared to a reference standard (e.g., ankle-brachial index [ABI], CT angiography, or MR angiography) in diagnosing PAD. | Up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of peripheral arterial disease longitudinal changes using ultrasound perfusion estimation | To assess longitudinal changes in perfusion values measured via ultrasound following medical, endovascular, or surgical interventions for PAD. | Up to 4 years |
Not provided
Inclusion Criteria:
Patient volunteers:
Healthy volunteers:
Exclusion Criteria:
Patient volunteers:
Healthy volunteers:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Azra Alizad | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |