NCT04417387: GENVASC

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)

Recruiting now Last updated 30 November 2023

What this trial tests

trial testing Observational in Cardiovascular Diseases in 30,000 participants. Currently enrolling.

Timeline

9 September 2012

Primary endpoint
31 March 2027

31 March 2027

Quick facts

Lead sponsor	University of Leicester
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	30,000
Start date	9 September 2012
Primary completion	31 March 2027
Estimated completion	31 March 2027
Sites	1 location across United Kingdom

Drugs / interventions tested

• Observational — full drug profile →

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

University of Leicester

Who can join

Adults 40 to 74, any sex, with Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Evaluating the clinical effectiveness of the NHS Health Check programme: a prospective analysis in the Genetics and Vascular Health Check (GENVASC) study.
   Debiec R, Lawday D, Bountziouka V, Beeston E, et al · · 2023 · cited 3× · PMID 37253489 · DOI 10.1136/bmjopen-2022-068025