Ultrasound Perfusion Estimation for Assessment of Peripheral Arterial Disease

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06952543
Status
Recruiting
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Conditions

  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

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

Study Details

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.

Key Dates

Start date
Mar 14, 2025
Status verified
Apr 2026
Primary completion
May 30, 2029
Completion
Aug 30, 2029

Study Design

Enrollment
400 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Study Group
    Symptomatic patients with claudication, at risk for peripheral arterial disease (PAD)
  • Experimental: Healthy Volunteers
    Healthy volunteers with normal ankle-brachial index (ABI)

Primary Outcome Measure

Detection of peripheral arterial disease using ultrasound perfusion estimation [ Time Frame: Up to 4 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Azra Alizad, MD
[email protected]
507-538-1727
Fatima Zohra, MS
[email protected]
5075382234
Azra Alizad (PRINCIPAL_INVESTIGATOR)

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