NCT04417387 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)
| NCT ID | NCT04417387 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Leicester |
| Condition | Cardiovascular Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 30,000 participants |
| Start Date | 2012-09-09 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30,000 participants in total. It began in 2012-09-09 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The Genetics and Vascular Health Check study (GENVASC) is a large study run in conjunction with Clinical Commissioning Groups and Primary Care practices across Leicester, Leicestershire and Northamptonshire. The purpose of GENVASC is to help determine whether gathering genetic information can improve the prediction of risk of Coronary Artery Disease (CAD). Currently, coronary risk scores are used to put individuals into low (\<10%), medium (10-20%) and high (\>20%) risk groups to help target prevention in individuals at the highest risk of developing CAD. While this approach has merit, since the majority of individuals fall into low or medium risk groups, in absolute terms more people develop CAD in these groups than in the high risk group (despite their proportional risk being lower). Therefore, improving the accuracy of risk categorisation for CAD has important public health and clinical benefits. In the last 5 years there has been remarkable progress in identifying genetic variants that affect risk of CAD, with much of this work being co-led from Leicester. These discoveries provide a framework for testing whether the addition of genetic information in the form of a genetic risk score can improve current risk prediction of CAD. The GENVASC study capitalises on the unique opportunity provided by the NHS Health Check Programme, which is being widely promoted and specifically targets all individuals aged 40-74 years who are free of cardiovascular disease. Consenting participants taking part in the health check programme are asked to provide an additional sample of blood to subsequently determine whether the addition of genetic information would have improved prediction of risk for coronary disease in individuals at low/medium risk. To date more than 100 GP surgeries in Leicester and Leicestershire are involved in the study, and recruitment has recently commenced in Northamptonshire . We aim to recruit and follow-up over 30,000 participants over the course of the study.
Eligibility Criteria
Inclusion Criteria: * Male and female patients who are eligible for an NHS Health Check * Aged between 40 and 74 years of age * Able to provide informed consent Exclusion Criteria: * History of preexisting cardiovascular disease * History of blood borne infection (such as HIV, Hepatitis B) * Unable to provide informed consent
Contact & Investigator
Nilesh J Samani, Professor
STUDY DIRECTOR
NIHR Leicester Biomedical Research Centre-Cardiovascular Theme
Frequently Asked Questions
Who can join the NCT04417387 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 74 Years, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04417387 currently recruiting?
Yes, NCT04417387 is actively recruiting participants. Contact the research team at epb2@leicester.ac.uk for enrollment information.
Where is the NCT04417387 trial being conducted?
This trial is being conducted at Leicester, United Kingdom.
Who is sponsoring the NCT04417387 clinical trial?
NCT04417387 is sponsored by University of Leicester. The principal investigator is Nilesh J Samani, Professor at NIHR Leicester Biomedical Research Centre-Cardiovascular Theme. The trial plans to enroll 30,000 participants.