RecruitingNAINTERVENTIONAL

PET Imaging of Inflammation and Lipid Lowering Study

This study aims to find better ways to detect and treat inflammation (swelling) in arteries, especially in people with high cholesterol. We're using a special scanning technique called PET-MRI, which is better at showing artery inflammation than older methods. Participants will receive either Inclisiran or Colchicine, which are treatments for high cholesterol and inflammation. Researchers also want to test a new ultrasound method to get a clearer picture of artery plaques. By comparing these new scanning methods and treatments, the study hopes to improve how we understand and manage heart and artery health for people in the UK. This could lead to more personalised and effective care in the future.

At a glance

Status

Recruiting

Phase

Sponsor

University of Cambridge

Enrolment target

Start

20 Mar 2023

Estimated completion

01 Mar 2026

Hypercholesterolemia Hypercholesterolemia, Familial Atherosclerosis Carotid Artery Plaque

What is this study about?

This study, called the PET Imaging of Inflammation and Lipid Lowering Study, is all about improving how we understand and treat problems like high cholesterol and hardened arteries (a common condition called atherosclerosis). When arteries harden, it means fatty deposits, called plaques, build up inside them, which can make it harder for blood to flow and increase the risk of heart attacks and strokes.

Currently, it's hard to get a really clear picture of the inflammation (swelling) within these plaques using standard scans. This study is testing a new type of scan called 68Ga-DOTATATE PET-MRI. This special scan is much better at picking up on the specific cells involved in inflammation within your arteries, especially in your neck arteries (carotid arteries). This helps doctors see how much inflammation is present and how it changes with treatment. They also want to try out a new, more detailed ultrasound method to look at these plaques.

Participants in the study will be given either a new cholesterol-lowering medicine called Inclisiran, or an anti-inflammatory medicine called Colchicine. The aim is to see if these medicines reduce the inflammation in the arteries. By using these advanced scans, researchers hope to discover how well these treatments work to reduce inflammation, which is a key part of artery disease. This information could lead to better ways to manage heart and artery conditions, ultimately helping people live healthier lives.

Key takeaways

Tests new ways to scan and treat high cholesterol and artery hardening.
Uses special PET-MRI scans to detect inflammation in neck arteries.
Compares medicines Inclisiran and Colchicine for their impact on artery health.
Aims to improve understanding and treatment of heart and artery conditions.
You will receive either active drug or a dummy treatment (placebo) by chance.
Your regular cholesterol medicines will continue throughout the study.

Who may be eligible?

To join this study, you need to be at least 18 years old and able to lie flat for scans. You must have high cholesterol, either the common type or a family-related form, or a mix of unhealthy fats in your blood. You also need a history of heart or blood vessel disease (like a previous heart attack or stroke) and your 'bad' cholesterol (LDL) should still be high, even if you're already taking cholesterol-lowering medicines.

Also, your cholesterol-lowering medicines must have been the same for at least 6 weeks before you start the study. You'll need to have a plaque (fatty deposit) in your neck artery (carotid artery) that's at least 15mm long, which will be checked with an ultrasound scan.

There are also reasons why you might not be able to join. For example, if you're a woman who could get pregnant and aren't using effective contraception, or if you can't have an MRI scan. If you've had certain side effects to statins, already take inclisiran or colchicine, or have severe kidney or liver problems, you wouldn't be able to take part. Also, if you've had a heart-related event in the last 6 months, have an uncontrolled inflammatory condition, or have certain other serious health issues or are on specific medications, you wouldn't be eligible.

Quick self-check

Are you 18 or older?
Do you have high cholesterol and a history of heart or blood vessel disease?
Is your 'bad' cholesterol (LDL) still high despite taking medicines?
Have you been on the same cholesterol-lowering medicines for at least 6 weeks?
Can you lie flat for scans?
Are you NOT currently taking Inclisiran or Colchicine?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll have several visits over a period of time. These visits will involve various tests, including blood samples and urine tests. You'll have two special scans: a 68Ga-DOTATATE PET-MRI scan and a detailed ultrasound scan of your neck arteries. These scans help us see the plaques and any inflammation.

You'll be randomly assigned to receive either Inclisiran, a medicine given as an injection, or Colchicine, which is taken as tablets. Some people will receive a dummy treatment (placebo) instead of the active drug, but neither you nor the study team will know which you're getting. You'll continue to take your regular cholesterol-lowering medicines throughout the study. We expect you'll have follow-up appointments to monitor your health and how you respond to the treatment and scans. The exact total duration of your participation will be explained to you in detail by the study team.

Potential risks and benefits

Taking part in this study could offer several potential benefits. These include careful monitoring of your health, access to innovative scanning technologies, and potentially receiving a new or effective medicine (Inclisiran or Colchicine) that could help manage your cholesterol and artery inflammation. However, there are also potential risks, such as side effects from the study medicines, which will be fully explained to you. The scans involve a small amount of radiation, though the level is very low and considered safe. There's also the inconvenience of time commitment for appointments and tests. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University of Cambridge
Cambridge, United Kingdom· Recruiting

Common questions

What is 'inflammation' in my arteries?

Inflammation is your body's natural response to injury or irritation. In arteries with plaques, it means your immune system is actively involved in the plaque, contributing to its growth and potential instability.

What is a PET-MRI scan?

It's a special type of scan that combines two powerful imaging methods: PET, which measures how your body processes certain substances, and MRI, which creates detailed pictures of your organs and tissues. This combination helps us see both the activity and structure of your arteries.

What is Inclisiran?

Inclisiran is a medicine that helps lower 'bad' cholesterol (LDL-C) by targeting the liver to reduce its production. It's given by injection a few times a year.

What is Colchicine?

Colchicine is an older medicine primarily used for gout, but it has also been found to reduce inflammation in the body, which might be helpful in hardened arteries.

Will I know if I'm getting a real drug or a dummy pill?

No, this is a 'double-blind' study. Neither you nor the study doctors will know whether you are receiving the active drug or a dummy treatment (placebo). This helps make sure the results are unbiased.

How to find out more

Jason M Tarkin, MBBS PhD

jt545@cam.ac.uk +44(0)1223331504 Official trial record

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