Proactive Cardiovascular Prevention Strategy in Subjects With High Genetic Risk
- Conditions
- Primary PreventionCardiovascular Diseases
- Interventions
- Other: CVD risk estimation incorporating the PRS and guideline based preventive interventions.Other: Standard GP care
- Registration Number
- NCT04291157
- Lead Sponsor
- Alar Irs
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- Male 30-65 years or female 40-70 years
- No history of ischemic heart disease, stroke, TIA or PAD in electronic health record
- No cholesterol lowering treatment
- No history of diabetes
- High PRS of CVD
- No physical or mental conditions precluding informed consent or participation
- History of ischemic heart disease, stroke, transitory ischemic attack (TIA) or peripheral artery disease (PAD) in electronic health record
- Cholesterol lowering treatment
- History of diabetes
- No consent to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Proactive CVD prevention CVD risk estimation incorporating the PRS and guideline based preventive interventions. Proactive invitation to total CVD risk estimation incorporating the PRS and provision of guideline based preventive interventions. Usual care Standard GP care Usual GP care (opportunistic CVD risk estimation and prevention upon usual GP contacts).
- Primary Outcome Measures
Name Time Method Total 10 year cardiovascular disease (CVD) risk 12 months 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.
- Secondary Outcome Measures
Name Time Method Satisfaction of GPs with intervention 12 months Satisfaction of GPs with intervention - descriptive questionnaire, analysed qualitatively
Cost-effectiveness of intervention 12 months, modelled over lifetime 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).
Treatment initiation (first prescription) or dose escalation (new prescription with a higher dose) of CVD preventive pharmacotherapy 12 months New prescription or a dose escalation of any anti-hypertensive, lipid lowering, anti-platelet or anti-smoking medicinal product.
Adherence to CVD prevention recommendations 12 months Adherence to CVD prevention recommendations - proportion of patients adhering to lifestyle advice as recorded by GP.
Systolic blood pressure 12 months Sitting systolic blood pressure measured by automated device at GP office, mmHg
Diastolic blood pressure 12 months Sitting diastolic blood pressure measured by automated device at GP office, mmHg
Total cholesterol 12 months mmol/L
BMI 12 months Body mass index, height (m) and weight (kg) combined (kg/m2)
Waist circumference 12 months cm, measured at GP office
Smoking status 12 months Self-reported smoking status as recorded at GP office
Physical activity 12 months Self-reported physical activity, min/week, as recorded at GP office
Satisfaction of gene donors with intervention 12 months Satisfaction of gene donors with intervention - descriptive questionnaire, analysed qualitatively
LDL cholesterol 12 months mmol/L
Trial Locations
- Locations (2)
Tartu University Hospital
🇪🇪Tartu, Estonia
North Estonia Medical Centre
🇪🇪Tallinn, Estonia