A polygenic risk score (PRS) will be developed and implemented into the primary care digital work-flow. 1000 study subjects with no known cardiovascular disease, diabetes or statin treatment and with high PRS (men of 30-65, women of 40-70 years of age) will be recruited from amongst the gene donors of Estonian Biobank (Estonian Genome Center at the University of Tartu). Subjects will be randomised to proactive primary preventive intervention incorporating provision of PRS information or usual care (opportunistic preventive strategy). Subjects in intervention group will be actively contacted and invited to a general practitioner (GP) based prevention intervention of total cardiovascular risk scoring and guideline recommended preventive measures. Subjects in control group will be observed for 12 month and then invited to a GP visit and provided the same information and advice as the intervention group. The impact of PRS on total 10 year cardiovascular disease (CVD) risk scoring will be assessed, the change in total 10 year CVD risk during the intervention will be measured and the difference in total 10 year CVD risk between the groups at month 12 will be reported. Satisfaction of subjects and GPs with the intervention will also be assessed as well as cost-effectiveness of the intervention.
A polygenic risk score (PRS) will be developed and implemented into the primary care digital work-flow. 1000 study subjects with no known cardiovascular disease, diabetes or statin treatment and with high PRS (men of 30-65, women of 40-70 years of age) will be recruited from amongst the gene donors of Estonian Biobank (Estonian Genome Center at the University of Tartu). Subjects will be randomised to proactive primary preventive intervention incorporating provision of PRS information or usual care (opportunistic preventive strategy). Subjects in intervention group will be actively contacted and invited to a GP based prevention intervention of total cardiovascular risk scoring and guideline recommended preventive measures. Subjects in control group will be observed for 12 month and then invited to a GP visit and provided the same information and advice as the intervention group. The impact of PRS on total 10 year CVD risk scoring will be assessed, the change in total 10 year CVD risk during the intervention will be measured and the difference in total 10 year CVD risk between the groups at month 12 will be reported. Satisfaction of subjects and GPs with the intervention will also be assessed as well as cost-effectiveness of the intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,000
Total CVD risk estimation using SCORE plus PRS and European Society of Cardiology (ESC) CVD prevention guideline based interventions.
Usual GP care (opportunistic CVD prevention)
North Estonia Medical Centre
Tallinn, Estonia
Tartu University Hospital
Tartu, Estonia
Total 10 year cardiovascular disease (CVD) risk
SCORE (Systematic COronary Risk Evaluation), estimates fatal cardiovascular disease events over a ten-year period in %. Employs categories of 1) low (calculated SCORE \<1%) 2) moderate-risk (calculated SCORE1% to \<5%), 39 ) high-risk (calculated SCORE5% to \<10%) and 3) very-high-risk (calculated SCORE ≥10%). Conroy RM , Pyorala K, Fitzgerald AP et al. Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. Eur H J2003;24:987-1003.
Time frame: 12 months
Treatment initiation (first prescription) or dose escalation (new prescription with a higher dose) of CVD preventive pharmacotherapy
New prescription or a dose escalation of any anti-hypertensive, lipid lowering, anti-platelet or anti-smoking medicinal product.
Time frame: 12 months
Adherence to CVD prevention recommendations
Adherence to CVD prevention recommendations - proportion of patients adhering to lifestyle advice as recorded by GP.
Time frame: 12 months
Systolic blood pressure
Sitting systolic blood pressure measured by automated device at GP office, mmHg
Time frame: 12 months
Diastolic blood pressure
Sitting diastolic blood pressure measured by automated device at GP office, mmHg
Time frame: 12 months
Total cholesterol
mmol/L
Time frame: 12 months
LDL cholesterol
mmol/L
Time frame: 12 months
BMI
Body mass index, height (m) and weight (kg) combined (kg/m2)
Time frame: 12 months
Waist circumference
cm, measured at GP office
Time frame: 12 months
Smoking status
Self-reported smoking status as recorded at GP office
Time frame: 12 months
Physical activity
Self-reported physical activity, min/week, as recorded at GP office
Time frame: 12 months
Satisfaction of gene donors with intervention
Satisfaction of gene donors with intervention - descriptive questionnaire, analysed qualitatively
Time frame: 12 months
Satisfaction of GPs with intervention
Satisfaction of GPs with intervention - descriptive questionnaire, analysed qualitatively
Time frame: 12 months
Cost-effectiveness of intervention
Incremental cost-effectiveness ratio (EUR/QALY): cost of intervention combined in an economic model with lifetime benefit (number of quality adjusted life years modelled based on change in total CVD risk, measured as primary endpoint).
Time frame: 12 months, modelled over lifetime
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