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)
GENVASC
Genetics and Vascular Health Check Study (GENVASC)
1 other identifier
observational
30,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 9, 2012
CompletedFirst Submitted
Initial submission to the registry
June 1, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
November 30, 2023
November 1, 2023
14.6 years
June 1, 2020
November 29, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
To retrospectively analyse whether the addition of a genetic risk score would have improved risk prediction of Coronary Artery Disease (CAD) in an otherwise healthy population.
10 years
Interventions
Eligibility Criteria
All patients in Leicestershire and Northamptonshire who are eligible for the NHS Health Check.
You may qualify if:
- 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
You may not qualify if:
- History of preexisting cardiovascular disease
- History of blood borne infection (such as HIV, Hepatitis B)
- Unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Leicesterlead
- University Hospitals, Leicestercollaborator
Study Sites (1)
Primary Care, LLR and Northamptonshire
Leicester, United Kingdom
Related Publications (1)
Debiec R, Lawday D, Bountziouka V, Beeston E, Greengrass C, Bramley R, Sehmi S, Kharodia S, Newton M, Marshall A, Krzeminski A, Zafar A, Chahal A, Heer A, Khunti K, Joshi N, Lakhani M, Farooqi A, Patel R, Samani NJ. Evaluating the clinical effectiveness of the NHS Health Check programme: a prospective analysis in the Genetics and Vascular Health Check (GENVASC) study. BMJ Open. 2023 May 30;13(5):e068025. doi: 10.1136/bmjopen-2022-068025.
PMID: 37253489DERIVED
Biospecimen
EDTA sample for DNA extraction and plasma.
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nilesh J Samani, Professor
NIHR Leicester Biomedical Research Centre-Cardiovascular Theme
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2020
First Posted
June 4, 2020
Study Start
September 9, 2012
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
November 30, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
Anonymised data to be shared with partner organisations