The GENVASC Study:Genetics and the Vascular Health Check Programme
Research type
Research Study
Full title
The GENVASC Study: Genetics and the Vascular Health Check Programme
IRAS ID
107325
Contact name
Nilesh J Samani
Contact email
Clinicaltrials.gov Identifier
Research summary
Cardiovascular diseases are the main cause of premature death and morbidity in the UK and worldwide. They poses a huge financial burden to the NHS. The best way to tackle them is to try and prevent them in the first place. Prevention of cardiovascular diseases requires better understanding of the factors that affect risk AND better methods for identifying individuals that are at increased risk. Improved prediction of who is at risk of cardiovascular disease is of benefit not only to the individual as preventative measures can be targeted earlier but also for society as a whole as prevention measures can be focused on those who are most at risk and therefore more cost-effectively. The principle objective of this project is to test whether new genetic risk factors identified for cardiovascular disease improve risk prediction. [COVID-19 amendment - approved 21 May 2020] This amendment seeks to enhance current data collection to incorporate participant data relating to COVID 19. This is inclusive of all reported incidents of symptomatic, suspected, and confirmed diagnosis recorded on both primary and secondary care medical records. Although the consent process includes a clause for contact of participants for future research the study team, therefore, proposes that additional consent for this collection is not required in order to timely answer questions in relation to public priority and urgency. There will be no amendment to the data collection process, the scientific critique or to the level of participant risk. Other than the collection of COVID related data alongside the currently collected data there is no other change to the study.\n\nAs a second follow-on phase for this arm, GENVASC participants, may be contacted for an additional data collection process to gain further information on who may have been infected and their experience during and post-infection. During this process, all GENVASC participants who have agreed for contact for future research or follow-up may be contacted via email, post or telephone. Participants may imply their consent with the return of the email or postal questionnaire, or verbal consent will be obtained for telephoned Participants will be asked to complete the COVID CRF or eCRF. Consent will be recorded in the eCRF and where appropriate a copy of the signed telephone ICF will be stored with the trial master file. The documentation for this phase of the amendment will follow in a nonsubstantial amendment once the relevant CRF questions are formulated. The collected data may be shared anonymously to analyse jointly with other similar national and international initiatives to get more robust insights.\n\n**Updated as a result of the Committee’s concerns**\nPIS and ICF amended to specify data usage statements\n\nRevised further on 18/05/20 after a teleconference with applicants in which it was agreed that the amendment would be restricted to the accessing of local medical records of current participants of the GENVASC study in order to determine their SARS-CoV-2 status. All other elements described in the original notice of substantial amendment were withdrawn.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
12/EM/0208
Date of REC Opinion
5 Jul 2012
REC opinion
Further Information Favourable Opinion