Ultrasound Perfusion Estimation for Assessment of Peripheral Arterial Disease

NCT06952543 | Recruiting

• 2 other identifiers: 24-0028021R01HL174785-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Detection of peripheral arterial disease longitudinal changes using ultrasound perfusion estimation

  Up to 4 years

Study Arms (2)

Study Group

EXPERIMENTAL

Symptomatic patients with claudication, at risk for peripheral arterial disease (PAD)

Diagnostic Test: Ultrasound Imaging

Healthy Volunteers

EXPERIMENTAL

Healthy volunteers with normal ankle-brachial index (ABI)

Diagnostic Test: Ultrasound Imaging

Interventions

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

Healthy Volunteers; Study Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Azra Alizad

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 1, 2025
• Study Start: March 14, 2025
• Primary Completion (Estimated): May 30, 2029
• Study Completion (Estimated): August 30, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)