Ultrasound Perfusion Estimation for Assessment of Peripheral Arterial Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound Imaging.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Ultrasound Perfusion Estimation for Assessment of PAD
Overview
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 test Ultrasound 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 a
Primary outcome measures
- Detection of peripheral arterial disease using ultrasound perfusion estimation [Time frame: Up to 4 years]
Secondary outcome measures (1)
- Detection of peripheral arterial disease longitudinal changes using ultrasound perfusion estimation [Time frame: Up to 4 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT06952543 · 24-002802 · 1R01HL174785-01