Ultrasound Imaging for Peripheral Arterial Disease

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Gangrene, Surgery, Ulcer, Vulnerable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Ultrasound Perfusion Estimation for Peripheral Arterial Disease?

Research shows that using ultrasound with contrast agents can improve imaging of blood flow in the legs for people with peripheral arterial disease, which may help in assessing and improving treatment outcomes. ^{1 2 3 4 5}

Is ultrasound imaging for peripheral arterial disease safe for humans?

The research articles reviewed do not provide specific safety data for ultrasound imaging in humans, but ultrasound is generally considered a safe, non-invasive imaging technique. ^{1 2 6 7 8}

How does ultrasound imaging differ from other treatments for peripheral arterial disease?

Ultrasound imaging for peripheral arterial disease is unique because it uses sound waves to create images of blood flow in the arteries, which is noninvasive and can be enhanced with contrast agents to improve accuracy. This differs from other methods like MR angiography, which uses magnetic fields and contrast material, or laser Doppler flowmetry, which measures blood flow and oxygen levels in tissues. ^{1 2 3 9 10}

What is the purpose of this trial?

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.

Research Team

Azra Alizad

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for individuals who may have Peripheral Arterial Disease (PAD), a condition affecting blood flow in the arteries, particularly in the legs. The study aims to include those who could benefit from early diagnosis and monitoring of PAD.

Inclusion Criteria

I am 18-75, have a normal weight, never smoked, and don't have heart disease or diabetes.

I am 18 or older with leg pain during walking, suspected of having PAD, and scheduled for a vascular test.

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.

I am a healthy volunteer with a BMI under 30, no smoking or major health issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment using ultrasound perfusion estimation to diagnose PAD

1-2 weeks

Monitoring

Participants are monitored for disease progression and response to interventional treatment using ultrasound perfusion estimation

Up to 4 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Ultrasound Perfusion Estimation

Trial Overview The trial is testing a new noninvasive ultrasound imaging technique designed to diagnose PAD more effectively and monitor disease progression as well as response to treatments.

Participant Groups

Group I: Study Group Experimental Treatment 1 Intervention

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

Group II: Healthy Volunteers Experimental Treatment 1 Intervention

Healthy volunteers with normal ankle-brachial index (ABI)

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Blood Oxygen Level-Dependent MR Imaging of Lower Extremities in Peripheral Artery Disease and Its Correlation With Walking Performance. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Peripheral arterial disease: comparison of color duplex US and contrast-enhanced MR angiography for diagnosis. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Ultrasound contrast-agent improves imaging of lower limb occlusive disease. [2019]

4. Ireland pubmed.ncbi.nlm.nih.gov

Dynamic contrast-enhanced ultrasound and transient arterial occlusion for quantification of arterial perfusion reserve in peripheral arterial disease. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Dynamic contrast-enhanced ultrasound for assessment of therapy effects on skeletal muscle microcirculation in peripheral arterial disease: pilot study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Limb stress-rest perfusion imaging with contrast ultrasound for the assessment of peripheral arterial disease severity. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Dynamic contrast-enhanced ultrasound for assessment of skeletal muscle microcirculation in peripheral arterial disease. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

A BMI-adjusted ultra-low-dose CT angiography protocol for the peripheral arteries-Image quality, diagnostic accuracy and radiation exposure. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Laser Doppler Flowmetry Combined with Spectroscopy to Determine Peripheral Tissue Perfusion and Oxygen Saturation: A Pilot Study in Healthy Volunteers and Patients with Peripheral Arterial Disease. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging based modeling of microvascular perfusion in patients with peripheral artery disease. [2020]