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Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

This study aims to understand how narrowed arteries in the legs (Peripheral Arterial Disease, or PAD) affect the rest of the body. PAD can cause leg pain and blockages, and it also increases the risk of heart attacks and strokes. Researchers will use special scans to look at inflammation, tiny calcium deposits, and blood clots in artery blockages in different parts of the body. By learning more about these processes, the study hopes to find out if blockages behave differently in various areas. This knowledge could help develop better treatments to stop the disease from getting worse and prevent serious issues like heart attacks and strokes.

At a glance

Status
Recruiting
Sponsor
University of Edinburgh
Enrolment target
100
Start
31 Jul 2025
Estimated completion
01 Jul 2029

What is this study about?

When you have Peripheral Arterial Disease (PAD), the arteries (blood vessels) in your legs can become narrowed and blocked. This happens because of a process called atherosclerosis, where fatty deposits and other substances build up on the artery walls. This makes it harder for blood to flow to your legs and feet, which can cause symptoms like pain when walking or, in severe cases, more serious problems like wounds that don't heal or even needing to have part of a leg removed. People with PAD are also at higher risk of blocked arteries in other parts of their body, which can lead to life-threatening conditions such as heart attacks and strokes.

Even with current treatments, the outlook for people with PAD hasn't improved much. That's why this study is so important. Researchers want to get a clearer picture of how atherosclerosis develops and behaves throughout the entire body, not just in the legs. They are particularly interested in understanding the links between inflammation (the body's response to damage), microcalcification (tiny specks of calcium that can build up in the arteries), and blood clots that form in these narrowed vessels.

By understanding these relationships better, doctors hope to find new ways to treat PAD more effectively. This could lead to therapies that specifically target these processes, helping to stop the disease from progressing and reducing the risk of heart attacks and strokes, which are major concerns for people with PAD. This study aims to gather vital information that could shape future treatments and improve the lives of those living with this condition.

Key takeaways

  • Aims to understand PAD better to find new treatments.
  • Uses special full-body scans, not new medicines.
  • Looks at arteries in legs and other body areas.
  • Seeks connections between inflammation, calcium, and clots.
  • Could help prevent future heart attacks and strokes.
  • Participation involves scan appointments, not daily routine changes.

Who may be eligible?

This study is looking for men and women aged 18 or over who have been diagnosed with Peripheral Arterial Disease (PAD) and are experiencing symptoms. This includes those who get cramping leg pain when walking that usually goes away with rest (called intermittent claudication), or those with more severe leg pain even at rest, or wounds or gangrene on their limb.

To join, your PAD diagnosis must be confirmed by specific tests, such as a low ankle-arm blood pressure ratio or significant narrowing of an artery. You might also be eligible if your PAD affects more than one area, or if you have other health conditions like diabetes, heart failure, or certain stages of kidney disease. If you've had a procedure to improve blood flow in your legs, like a bypass surgery or a stent, or even had a leg or foot amputation because of PAD, you might also be able to join.

However, there are reasons you might not be able to take part. For example, if you are allergic to certain medications or imaging dyes, or have severe kidney or liver disease. Pregnant or breastfeeding women, and women who could become pregnant and are not using reliable contraception, cannot join. Also, if you've recently had surgery on your leg (in the last 6 weeks), have certain other long-term medical needs, or any condition that makes it unlikely you can complete the study, you would not be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with symptomatic Peripheral Arterial Disease (PAD)?
  3. Are you able to give informed consent (understand and agree to take part)?
  4. Are you not pregnant or breastfeeding, and using reliable contraception if you could become pregnant?
  5. Do you have severe kidney or liver disease (check with your doctor)?
  6. Have you had recent leg surgery (within the last 6 weeks)?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo a series of special scans over time. These include different types of PET-CT scans and CT angiogram scans. These scans use small amounts of special tracers to help doctors see what's happening inside your arteries. The study is observational, meaning researchers will be watching and taking pictures, but you won't be given any new medications or treatments as part of the study itself. You will continue to receive your usual medical care from your own doctors. The researchers will be looking at how things like inflammation and calcium build-up in your arteries relate to each other. The total number of visits and the overall duration will be explained in detail by the study team if you are eligible and interested.

Potential risks and benefits

Taking part in this study might not directly benefit you, but the information gained could help improve treatments for people with PAD in the future. The scans involve exposure to a small amount of radiation, similar to other medical scans you might have. You might also experience minor discomfort from the injections of the special tracers used for the scans. You will have full rights to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Royal Infirmary of Edinburgh
    Verified postcode
    Edinburgh, United Kingdom· Recruiting

Common questions

What is Peripheral Arterial Disease (PAD)?

PAD is a condition where narrowed arteries reduce blood flow to your limbs, most commonly your legs, causing pain or other problems.

What are PET-CT scans?

PET-CT scans are special imaging tests that combine two types of scans to give detailed pictures of your body, often using a small amount of a 'tracer' to highlight specific areas.

Will I receive new treatment in this study?

No, this is an 'observational' study. You will not receive any new medications or treatments as part of the study itself; you will continue with your regular care.

What are the main risks of participating?

The main risks involve a small amount of radiation from the scans and potential minor discomfort from injections of the tracers used for the scans.

Can I leave the study at any time?

Yes, you are free to withdraw from the study at any point, and your decision will not affect your medical care.

How to find out more

Allison c Winarski, MBChB, MRCS(Ed)

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Symptomatic and Systemic Atherosclerotic Plaque Activity in …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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