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NCT04417387Recruiting

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)

Genetics and Vascular Health Check Study (GENVASC)

Source: ClinicalTrials.gov · Last updated 30 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
30000 (estimated)
First submitted
1 Jun 2020
Start date
9 Sept 2012
Primary completion date
31 Mar 2027
Lead sponsor
University of Leicester
NCT number
NCT04417387

What you commit to

  • Study type: Observational
  • Planned participants: 30000
  • From 9 Sept 2012 to the primary completion date, 31 Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of preexisting cardiovascular disease
  • History of blood borne infection (such as HIV, Hepatitis B)

Other

  • Unable to provide informed consent

Who the study is looking for

  • 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

Age in the registry: 40 years to 74 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Primary Care, LLR and Northamptonshire
Coordinator of this site? Confirm its status
LeicesterUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.