RecruitingNAINTERVENTIONAL

SECURE Trial: Stress Echocardiography With Carotid Ultrasound vs Routine CT Coronary Angiography in Chronic Coronary Syndrome for Endpoints

The SECURE trial is looking into better ways to detect heart circulation problems, known as heart disease. Around 160,000 deaths each year are due to heart and circulation diseases in the UK. This study compares two common tests: a CT scan of the heart arteries, and an ultrasound of the heart (stress echocardiography) combined with an ultrasound of the neck arteries. The CT scan can show early signs of disease, while the ultrasound shows if enough blood reaches the heart. The trial aims to see if combining the ultrasounds can provide all necessary information in one go, helping doctors decide on the best treatment. Participants will be followed for 5 years to see how these different diagnostic approaches affect their health.

At a glance

Status

Recruiting

Phase

Sponsor

London North West Healthcare NHS Trust

Enrolment target

2,000

Start

18 Sep 2023

Estimated completion

31 Dec 2031

Chronic Coronary Syndrome Coronary Disease Coronary Artery Disease

What is this study about?

Cardiovascular diseases, which affect the heart and blood vessels, are a major health concern in the UK, causing many deaths every year. A common type is coronary heart disease, where fatty deposits, called atherosclerosis, build up in the blood vessels supplying the heart. This can lead to chest pain, or even a heart attack if a vessel becomes blocked.

Currently, doctors use different tests to find out if someone has coronary heart disease. Two main tests are a CT scan of the heart arteries (CT coronary angiography) and an ultrasound scan of the heart (stress echocardiography). The CT scan is great for spotting even very early signs of disease in the arteries, but it can be hard to tell how severe the problem is if there's a lot of build-up. The ultrasound, on the other hand, shows whether your heart muscle is getting enough blood, which helps determine if there's a serious blockage that needs treatment. However, it can't see the tiny early signs of disease in the arteries.

This study, called SECURE, is investigating whether combining the heart ultrasound with an ultrasound of the neck arteries could provide a more comprehensive picture. We know that if there's fatty build-up in other arteries, like those in the neck, it's very likely to be present in the heart arteries too. By combining these two ultrasound tests, researchers hope to find a single, non-invasive way to detect both early disease and more severe problems that need treatment. This could help doctors make more informed decisions about the best care for patients, without needing multiple different tests.

Key takeaways

This study compares two ways to check for heart disease: a heart CT scan or a heart and neck ultrasound.
It aims to find the most effective test for detecting both early and severe heart disease.
Participants will be followed for 5 years to see the long-term health outcomes.
The goal is to improve diagnosis and help doctors choose the best treatment for patients.
Participation involves undergoing one of the diagnostic test pathways and completing questionnaires over time.

Who may be eligible?

This study is looking for adults aged 18 or over who have been referred to a specialist for investigations into possible heart artery disease. You would typically be considered if your doctor thinks you need further imaging tests to check for this condition.

You might be eligible if you have symptoms that suggest angina (chest pain or discomfort) that is brought on by activity and relieved by rest or medication. Your doctor will assess whether your symptoms fit this description and if your risk of heart disease is at a certain level.

However, you wouldn't be able to join if you've recently had a heart attack or need urgent treatment. Also, if you already know you have significant blockages in your heart arteries, have had previous heart procedures, or have had recent heart scans, you wouldn't be eligible. There are also specific medical conditions or medication allergies that would prevent you from taking part, such as certain kidney problems, severe uncontrolled high blood pressure, or being pregnant.

Quick self-check

Are you 18 years old or older?
Has your doctor referred you for tests to check for heart artery disease?
Do you have chest pain that comes with activity and eases with rest or medication?
Have you NOT had a heart attack or previous heart procedures recently?
Are you NOT pregnant and don't have certain specific medical conditions (like severe kidney problems or uncontrolled high blood pressure)?

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

What does participation involve?

If you join the SECURE study, you will be randomly assigned to have one of two types of heart scans: either a CT scan of your heart arteries, or a combination of a special heart ultrasound (stress echocardiography) and an ultrasound of your neck arteries. You won't get to choose which test you have, as this is decided by chance to make the study fair.

After your scan, we will follow your health for 5 years. During this time, we will keep track of any health events or changes and ask you to complete a questionnaire. This helps us understand the long-term impact of the different diagnostic approaches. The specific number of follow-up visits will be communicated to you by the study team, but generally it involves monitoring your health and completing surveys over time.

Potential risks and benefits

Participating in this study might benefit you by providing a comprehensive assessment of your heart health, potentially leading to a more tailored treatment plan sooner. For some, the study might help avoid procedures that are not needed. You'll receive one of the standard diagnostic tests for heart disease, but the combination of tests in one group is experimental. As with any medical test, there are small risks associated with the scans themselves, such as exposure to a small amount of radiation with the CT scan, or potential reactions to contrast dyes used. You can withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

London North West University Healthcare NHS Trust
Harrow, United Kingdom· Recruiting

Common questions

What is coronary heart disease?

It's a condition where fatty material builds up in the blood vessels supplying your heart, which can cause chest pain or even a heart attack.

What's the difference between the two main tests being studied?

A CT scan of the heart arteries shows early signs of disease, while a stress echocardiography shows if your heart muscle is getting enough blood. The study combines the latter with a neck artery ultrasound.

Will I have to pay to be in the study?

No, all study-related tests and follow-up will be provided at no cost to you.

How long will I be involved in the study?

You'll be followed for 5 years after your initial tests to see how your health progresses.

Can I leave the study once I've started?

Yes, you can withdraw from the study at any time without it affecting your medical care.

How to find out more

Emma Howard

emma.howard16@nhs.net 0208 869 2548 Official trial record

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