Peripheral Arterial Disease
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTUltrasound Imaging
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
Sponsors
Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Patient volunteers: * Male and Female, ages 18 years old and up * Symptom of claudication and suspected for PAD * Scheduled for vascular testing. Healthy volunteers: * Male and female, ages 18-75 years old and up * Normal BMI * No history of smoking, cardiovascular disease, or diabetes.
Exclusion criteria
Patient volunteers: * Patients with gangrene * Patients having surgery or stent * Patients with ulcer on their leg * Any health condition that does not allow proper use of ultrasound scanning * People considered in "vulnerable" populations. Healthy volunteers: * Include volunteers with BMI not more than 30 * No history of smoking * No history of (diabetes, hypertension, cardiovascular diseases) * People considered in "vulnerable" populations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of peripheral arterial disease using ultrasound perfusion estimation | Up to 4 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of peripheral arterial disease longitudinal changes using ultrasound perfusion estimation | Up to 4 years | To assess longitudinal changes in perfusion values measured via ultrasound following medical, endovascular, or surgical interventions for PAD. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAzra Alizad
Mayo Clinic
Outcome results
None listed