Ultrasound Perfusion Estimation for Assessment of Peripheral Arterial Disease
Ultrasound Perfusion Estimation for Assessment of PAD
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
-
Contact:
- Azra Alizad, MD
- Phone Number: 507-538-1727
- Email: alizad.azra@mayo.edu
-
Contact:
- Fatima Zohra, MS
- Phone Number: 5075382234
- Email: Zohra.Fatima@mayo.edu
-
Principal Investigator:
- Azra Alizad
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study Group
Symptomatic patients with claudication, at risk for peripheral arterial disease (PAD)
|
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 |
|
Experimental: Healthy Volunteers
Healthy volunteers with normal ankle-brachial index (ABI)
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection of peripheral arterial disease using ultrasound perfusion estimation
Time Frame: 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.
|
Up to 4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection of peripheral arterial disease longitudinal changes using ultrasound perfusion estimation
Time Frame: Up to 4 years
|
To assess longitudinal changes in perfusion values measured via ultrasound following medical, endovascular, or surgical interventions for PAD.
|
Up to 4 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Azra Alizad, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-002802
- 1R01HL174785-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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