Sample and data collection for cardiovascular research
Research type
Research Study
Full title
Sample and data collection for cardiovascular research
IRAS ID
31239
Contact name
Nilesh Samani
Contact email
Research summary
The principal objective is to improve upon our understanding of disease mechanisms in cardiovascular disease, using plasma and urine proteins or chemicals and a patient’s genetic makeup, which may impact on the diagnosis and assessment of prognosis of cardiovascular disease.[COVID-19 amendment 29/04/2020] This amendment seeks to enhance current data collection to incorporate participant data relating to COVID 19. The current cohort of participants enrolled onto the BRICCS study represents a wide demographic, age range and ethnicity mix. It is proposed that the study’s rich data and sample collection in secondary care provides opportunity to investigate why people with cardiovascular diseases are at higher risk from Covid-19 infection, to define the cardiovascular complications of Covid-19 and to understand the impact of Covid-19 on patients with cardiovascular diseases.\nThis 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 proposes that additional consent for this collection is not required in order to timely\nanswer 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.\nAs a second follow-on phase for this arm, BRICCS 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.\nDuring this process, all BRICCS 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\nCRF 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 non-substantial 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.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
09/H0406/114
Date of REC Opinion
3 Feb 2010
REC opinion
Further Information Favourable Opinion