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The HEART Study and version 1.0

  • Research type

    Research Study

  • Full title

    The Healthcare Evaluation of Absolute Risk Testing Study: A multi-centre, single arm, pragmatic study in primary care setting

  • IRAS ID

    285420

  • Contact name

    Ahmet Fuat

  • Contact email

    ahmetfuat@nhs.net

  • Sponsor organisation

    Genomics Plc

  • Clinicaltrials.gov Identifier

    46497, CPMS

  • Duration of Study in the UK

    0 years, 6 months, 20 days

  • Research summary

    Early detection of risk in order to prevent disease is a fundamental challenge for public health. In line with the “Predictive Prevention“ strategy, supported by the Government and public health bodies, there is an opportunity to embed genetics into healthcare. Genetics can be tested at any age and is constant for life. The combination of a large number of disease-associated common genetic variants into a predictive score is referred to as a Polygenic Risk Score (PRS). PRSs are clinically useful predictors for multiple diseases, such as cardiovascular disease (CVD), where they generate similar or greater effect sizes than smoking or high blood pressure. An Integrated Risk Tool (IRT) is an algorithm which combines an individual’s PRS (genetic risk score) with validated clinical risk factors (eg. BMI or smoking). The output for an individual synthesises their genetic and lifestyle factors to give them an overall understanding of their risk of developing disease. We have shown that this tool has superior predictive power in the UK Biobank cohort compared to other PRSs.\n\nThis 1000 patient study at circa 10 GP practices will evaluate the operational use of the IRT for CVD in GP practices and the perceived value for patients and healthcare professionals.\n\nEligible participants are aged 45-64 years old, either biological sex\nExclusion Patients using statins or not eligible for NHS health check are excluded.\n\nVisit 1 (Baseline) includes consent, demographics, blood collection for all participants of whom 100 will have additional saliva samples, QRISK2 score and a short questionnaire (4 questions).\nVisit 2 (Results)will inform participants of their results and collect adverse events.\nVisit 3 (Questionnaire) participants will receive an online questionnaire.\nVisit 4 (Interview)only 30 participants will be selected for interview.\nHealthcare professionals conducting the study are asked to complete a questionnaire and some will be invited for qualitative follow-up sessions.\n

  • REC name

    North of Scotland Research Ethics Committee 1

  • REC reference

    21/NS/0097

  • Date of REC Opinion

    17 Aug 2021

  • REC opinion

    Further Information Favourable Opinion