RecruitingOBSERVATIONAL

The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)

The GENVASC study, across Leicestershire and Northamptonshire, investigates if including genetic information can improve how we predict a person's risk of developing coronary artery disease (CAD), a common type of heart disease. Currently, doctors use risk scores to identify people who might benefit from preventative care. However, many people who go on to develop heart disease are initially categorised as low or medium risk. This study wants to see if adding genetic details can make these predictions more accurate, potentially helping more people avoid heart problems. It involves participants aged 40-74 who are already having an NHS Health Check and don't have existing heart disease, by asking for an extra blood sample.

At a glance

Status

Recruiting

Sponsor

University of Leicester

Enrolment target

30,000

Start

09 Sep 2012

Estimated completion

31 Mar 2027

Cardiovascular Diseases

What is this study about?

Heart disease is a major health concern in the UK, often leading to serious illness or early death. Doctors currently use health information like age, gender, smoking habits, blood pressure, and cholesterol levels to estimate a person's risk of developing heart disease over the next ten years. This helps them decide who might need preventative treatments or lifestyle changes. However, these current methods aren't perfect, as many people who develop heart disease were originally thought to be at low or medium risk. This is because, even if the risk is small for an individual, a large number of people in these groups adds up to many cases of heart disease.

Now, scientists have made exciting progress in understanding how our genes can influence our risk of heart disease. This study, called GENVASC, is bringing together this new genetic knowledge with the traditional risk assessment. The main goal is to find out if adding information from a person's genes can make our predictions much more accurate, especially for those who wouldn't normally be considered at high risk. If we can better identify everyone at higher risk, we can offer them advice or treatment earlier, potentially preventing future heart problems.

The GENVASC study is taking place in Leicestershire and Northamptonshire. It's working with the NHS Health Check programme, which offers free health checks to everyone aged 40 to 74 who doesn't already have heart disease. If you're attending one of these health checks and meet the study's criteria, you might be asked if you'd like to take part. The study aims to recruit over 30,000 people to help understand the role of genetics in predicting heart disease.

Key takeaways

Aims to improve heart disease prediction using genetic information.
Involves providing an extra blood sample during an NHS Health Check.
Focuses on people aged 40-74 without existing heart disease.
Participation helps scientists understand heart disease better.
No direct treatments or medicines from the study itself.
You can withdraw at any time without affecting your medical care.

Who may be eligible?

To be considered for this study, you need to be eligible for an NHS Health Check, which means you're generally between 40 and 74 years old.

It's important that you don't already have a history of heart or blood vessel disease. Also, you must not have certain blood infections, such as HIV or Hepatitis B, as this might affect the study results or the safety of handling samples.

Finally, you need to be able to understand what the study involves and willingly agree to participate. This means you would need to be able to give your 'informed consent' to take part.

Quick self-check

Are you between 40 and 74 years old?
Are you eligible for an NHS Health Check?
Do you currently have heart or blood vessel disease?
Do you have certain blood-borne infections (like HIV or Hepatitis B)?
Can you understand the study information and agree to take part?

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

What does participation involve?

If you decide to take part in the GENVASC study, your involvement would be quite straightforward. Since this is an 'observational' study, it means researchers will be observing information and not giving you any new medicines or treatments. Your participation is linked with your routine NHS Health Check. When you attend your Health Check, in addition to the standard checks, you would be asked to provide an extra blood sample. This sample would be used to look at your genetic information as part of the study. There will be no further appointments or changes to your usual healthcare. The study will then follow up on your health over time through your medical records. The total duration of your participation, meaning how long the researchers will continue to observe your health, will be ongoing as part of the large-scale nature of the study.

Potential risks and benefits

Taking part in a study like GENVASC usually carries very few risks. The main involvement is providing an additional blood sample during your routine NHS Health Check, which is a common and generally safe procedure, though there's a small chance of bruising. You won't receive any direct medical advice or treatment from the study itself. While there are no direct benefits to you as an individual, your participation will greatly contribute to our understanding of heart disease. This could lead to better prediction methods and improved preventative care for future generations. You are free to withdraw from the study at any time without giving a reason, and this will not affect your ongoing medical care.

Locations (1)

Primary Care, LLR and Northamptonshire
Leicester, United Kingdom· Recruiting

Common questions

What is coronary artery disease?

It's a common type of heart disease where the blood vessels supplying the heart become narrowed, potentially leading to heart attacks or other problems.

What is an 'observational' study?

An observational study means researchers watch and collect information about people over time without giving them any specific treatments or medicines related to the study.

Will taking part affect my NHS Health Check?

No, your NHS Health Check will proceed as normal. You'll simply be asked to provide an additional blood sample for the study at the same time.

Will I get my genetic results?

The study aims to gather overall information for research purposes and will not provide individual genetic results back to participants.

Who is running this study?

This study, GENVASC, is run by researchers in conjunction with local NHS healthcare groups and GP practices across Leicester, Leicestershire, and Northamptonshire.

How to find out more

Emma P Beeston

epb2@leicester.ac.uk 0116 204 4738 Official trial record

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