Ultrasound Perfusion Measurement for Peripheral Artery Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an ultrasound technique to track changes in blood flow for individuals with peripheral artery disease (PAD), a condition where narrowed arteries reduce blood flow to the limbs. The study aims to detect PAD early and monitor how the condition evolves or responds to treatments. Healthy volunteers and individuals with symptoms like claudication (leg pain when walking) who are scheduled for vascular tests might be suitable candidates. The goal is to develop a reliable, cost-effective method to improve PAD management. As a Phase 2 trial, this research measures the effectiveness of the ultrasound technique in an initial, smaller group, offering participants a chance to contribute to innovative PAD management.
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 prior data suggests that this ultrasound imaging technique is safe for assessing peripheral artery disease?
Research has shown that ultrasound perfusion imaging is generally safe. As a non-invasive method, it avoids surgery or entering the body, reducing risk compared to other procedures. Although detailed safety data for this specific ultrasound type isn't always available, it is commonly used in labs to assess blood flow. The operator's skill can affect image quality but typically does not impact safety. Overall, ultrasound is a well-tolerated and accessible tool for evaluating conditions like peripheral artery disease.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a new way to detect and monitor peripheral artery disease (PAD) using ultrasound perfusion imaging. Unlike traditional methods like the ankle-brachial index, which can be invasive or uncomfortable, this technique is non-invasive and potentially more cost-effective. It aims to provide a clear, quantitative estimation of blood flow in the calf muscles, which could help in the early detection of PAD and in tracking how well patients respond to treatment. This innovative approach could revolutionize how PAD is diagnosed and monitored, making it easier and more accessible for patients.
What evidence suggests that this ultrasound imaging technique is effective for assessing peripheral artery disease?
Research has shown that ultrasound imaging is a promising method for checking peripheral artery disease (PAD). In this trial, one arm will focus on the early detection of PAD, assessment of disease progression, and monitoring treatment response using ultrasound perfusion imaging. Studies have found that this technique effectively measures blood flow in the legs, aiding in early detection and monitoring of PAD. For example, using ultrasound without contrast agents has successfully demonstrated blood flow, making it a valuable tool for diagnosing PAD. Additionally, ultrasound can assess blood flow to muscles during exercise, which is crucial for understanding how PAD affects circulation. Overall, ultrasound imaging offers a non-invasive and cost-effective way to track PAD and its response to treatment.46789
Who Is on the Research Team?
Azra Alizad, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for men and women over 18 who have symptoms of claudication, which often indicates peripheral arterial disease (PAD), and are scheduled for vascular testing. It's not suitable for patients with gangrene, lower leg amputations, ulcers, or conditions that prevent ultrasound use. Vulnerable populations are also excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Early Detection and Assessment
Quantify perfusion of calf muscle in patients with lower leg claudication and compare results to healthy individuals
Treatment Response Monitoring
Quantify perfusion of calf muscle in PAD patients at 3 time points, 6 months, and every year after treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ultrasound
Trial Overview
The study is exploring the effectiveness of an ultrasound technique to track how PAD progresses and responds to treatment by looking at changes in tiny blood vessels and blood flow.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
A group of healthy volunteers ages 18 and above with no history of smoking, cardiovascular, diabetes or surgery on legs.
The objective of this arm of the study is to evaluate the potentials of Ultrasound Perfusion imaging technique for early detection of peripheral arterial disease in patients and assess the disease progression and monitor the treatment response. The investigators anticipate that our new cost-effective and non-invasive ultrasound perfusion technique offers a quantitative perfusion estimation of calf muscle that would separate PAD from non-PAD and help early detection of PAD and would help monitoring the disease progression and treatment response.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Citations
Sonography Vascular Peripheral Arterial Assessment ... - NCBI
Duplex ultrasound plays a key role not only in initial diagnosis but also in monitoring disease progression, evaluating treatment effectiveness, ...
Contrast-free ultrasound imaging for blood flow ...
In this study, we present a contrast-free ultrasound-based quantitative blood flow imaging technique for PAD diagnosis.
Ultrasound and Photoacoustic Imaging of Peripheral Arteries
The average success rates for imaging the carotid, common femoral and superficial femoral arteries in healthy volunteers were 75%, 100% and 33.3%, respectively, ...
Limb Stress-Rest Perfusion Imaging With Contrast ...
Limb microvascular perfusion imaging during exercise, using contrast-enhanced ultrasound can evaluate muscle blood in patients with peripheral arterial disease.
Contrast ultrasound perfusion imaging of lower extremities in ...
It is estimated that ∼15–20% of patients with PAD will progress to critical limb ischaemia, which is associated with a 1-year mortality rate of about 20%.6–8 ...
Perfusion imaging techniques in lower extremity peripheral ...
The examination is safe, cheap and accessible in most vascular laboratories. However, like all ultrasound examinations, it is operator-dependent and is limited ...
Ultrasound Imaging for Peripheral Arterial Disease
Is ultrasound imaging for peripheral arterial disease safe for humans? The research articles reviewed do not provide specific safety data for ultrasound imaging ...
New horizons in nuclear cardiology: Imaging of peripheral ...
This review provides a comprehensive reassessment of radiotracer-based imaging of PAD in preclinical and clinical studies, emphasizing the challenges that arise ...
Role of Doppler Ultrasound in Assessing the Severity ...
Our study shows that Duplex Doppler sonography aided by color Doppler sonography can accurately locate the site and severity of stenosis/occlusion.
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