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The goal of this clinical trial is to determine whether incorporating a polygenic risk score (PRS) can optimize primary cardiovascular disease prevention in individuals with intermediate cardiovascular risk.
The main questions it aims to answer are:
Participants will:
Coronary artery disease (CAD) remains the leading cause of mortality worldwide. While current cardiovascular disease (CVD) prevention guidelines rely on clinical risk scores such as SCORE2, these tools may underestimate or overestimate risk in individuals with intermediate clinical risk. Polygenic risk scores (PRS) aggregate the effect of multiple common genetic variants and may provide additional predictive value when combined with traditional risk assessment.
This randomized controlled trial evaluates whether incorporating a PRS for CAD (PRS-CAD) into clinical decision-making improves cardiovascular risk stratification and leads to better primary prevention in individuals with intermediate estimated 10-year cardiovascular risk.
Participants aged 40-69 years with intermediate CVD risk based on the SCORE2 algorithm will be randomized 1:1 into two groups. In the intervention arm, the PRS-CAD will be calculated using a validated genome-wide algorithm and integrated with the SCORE2 risk to generate a combined PRS-CAD-SCORE2 estimate. Risk will be communicated to participants and their healthcare providers using a standardized, structured communication tool developed by the study team. Participants with elevated combined risk will be referred to lipid clinics for further evaluation. In the control arm, participants will receive standard SCORE2-based risk communication, without inclusion of genetic information.
All participants will receive written lifestyle guidance . Physicians will receive the results in a structured format.
The primary endpoint is the change in SCORE2 from baseline to 15 months. Secondary endpoints include changes in blood pressure, lipid levels, glucose, HbA1c, hs-CRP, BMI, weight, adherence to the Mediterranean diet (Predimed score), physical activity (IPAQ), tobacco abstinence, medication adherence (MARS), and psychological measures (DASS-21, motivation for change, satisfaction with risk communication). Prescription rates of statins and other preventive therapies, new diagnoses (e.g., diabetes), and new cardiovascular events will also be recorded. Epigenomic analyses will be conducted to explore interactions between genetic risk, lifestyle, and DNA methylation.
All outcomes will be assessed at 15 months with blinded outcome assessment. The study aims to inform the clinical utility of integrating PRS into preventive cardiovascular care and support the move toward personalized medicine in primary prevention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polygenic Risk Score Combined with SCORE2 | Experimental | Participants in this arm will receive cardiovascular risk assessment using a combination of traditional clinical risk factors (SCORE2 algorithm) and a polygenic risk score for coronary artery disease (PRS-CAD). The combined risk (PRS-CAD-SCORE2) will be communicated using a structured communication tool developed by the study team. Participants and their healthcare providers will receive the results, and those with elevated risk will be referred to a lipid consultation. Lifestyle guidance and educational materials will also be provided. |
|
| SCORE2-Based Risk Assessment | Active Comparator | Participants in this arm will receive standard cardiovascular risk assessment using the SCORE2 algorithm only. Risk results will be communicated using the same structured communication tool, without inclusion of genetic information. No polygenic risk score will be calculated or disclosed. Participants and their healthcare providers will receive the standard risk results and general lifestyle recommendations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polygenic Risk Score for Coronary Artery Disease (PRS-CAD) | Diagnostic Test | A polygenic risk score will be calculated based on genome-wide genotyping and combined with SCORE2 clinical risk factors to estimate personalized cardiovascular risk. The combined risk (PRS-CAD-SCORE2) will be communicated to participants and their healthcare providers using a standardized communication tool. Participants with elevated risk will be referred to a lipid clinic. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SCORE2 between baseline and 18 months | Mean change in SCORE2 cardiovascular risk score from baseline to 18-month follow-up, comparing the intervention (PRS-CAD + SCORE2) and control (SCORE2 only) arms. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in systolic blood pressure | Measured using validated automated oscillometric device at rest | Baseline to 18 months |
| Change in diastolic blood pressure | Measured using validated automated oscillometric device at rest |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Rodondi, MD | University of Bern | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bern, Institute of Primary Health Care (BIHAM) | Bern | 3012 | Switzerland | |||
| Hôpital Fribourgeois (HFR) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37984334 | Background | De Montmollin M, Betrisey S, Feller M, Moutzouri E, Blum MR, Amsler J, Papazoglou DD, Moller B, Rodondi N. Achilles tendon ultrasonography in the clinical screening of familial hypercholesterolaemia - a cross-sectional analysis. Swiss Med Wkly. 2023 Nov 20;153:40127. doi: 10.57187/smw.2023.40127. | |
| 32154731 | Background |
| Label | URL |
|---|---|
| UK government consultation paper outlining a national strategy to shift healthcare towards prevention, including the potential role of genomics and polygenic risk scores in personalized disease prevention. | View source |
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IPD will only be shared after official request
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Study nurse/Research Fellow providing the information of cardiovascular risk at baseline will be masked. Patients will be masked as both groups will receive genetic results (intervention group during the study, control group at the end of the study).
|
| Standardized Risk Communication Tool (SCORE2) | Behavioral | Participants will receive risk communication based solely on clinical risk factors using the SCORE2 algorithm. The same structured communication tool will be used (without genetic data), along with general lifestyle guidance. |
|
| Baseline to 18 months |
| Change in total cholesterol | Measured via fasting venous blood sample | Baseline to 18 months |
| Change in HDL cholesterol (HDL-C) | Measured via fasting venous blood sample | Baseline to 18 months |
| Change in LDL cholesterol (LDL-C) | Measured via fasting venous blood sample | Baseline to 18 months |
| Change in triglyceride levels | Measured via fasting venous blood sample | Baseline to 18 months |
| Change in fasting glucose | Measured via fasting venous blood sample | Baseline to 18 months |
| Change in HbA1c | Measured via venous blood sample | Baseline to 18 months |
| Change in high-sensitivity C-reactive protein (hs-CRP) | Measured via fasting venous blood sample | Baseline to 18 months |
| Change in DNA methylation patterns | Assessment of genome-wide DNA methylation changes from peripheral blood samples. DNA methylation will be analyzed in relation to adherence to the Mediterranean diet (measured via Predimed 14-item questionnaire) and its interaction with polygenic risk scores for coronary artery disease. | Baseline to 18 months |
| Tobacco abstinence status | Self-reported smoking status assessed at follow-up | Baseline to 18 months |
| Change in body mass index (BMI) | Calculated using measured weight and height (kg/m²) | Baseline to 18 months |
| Change in body weight | Measured in kilograms using calibrated scale | Baseline to 18 months |
| Change in dietary adherence | Measured by the Predimed 14-item questionnaire (score range: 0-14; higher scores indicate greater adherence to the Mediterranean diet) | Baseline to 18 months |
| Change in physical activity level | Assessed using the International Physical Activity Questionnaire (IPAQ, long form; score expressed in MET-minutes/week; higher values indicate greater physical activity). | Baseline to 18 months |
| Change in medication adherence | Assessed using the Medication Adherence Report Scale (MARS, 5-item version) score range: 5-25; higher scores indicate better adherence. | Baseline to 18 months |
| Change in motivation for lifestyle change | Measured using the 32-item Readiness for Change Questionnaire; score range depends on subscale (e.g., Precontemplation, Contemplation, Action); higher scores indicate greater readiness for behavior change. | Baseline to 18 months |
| Change in psychological well-being | Assessed using the Depression Anxiety Stress Scale (DASS-21); each subscale score ranges from 0 to 42, with higher scores indicating greater severity of symptoms. | Baseline to 18 months |
| Participant satisfaction with the intervention | Measured via structured self-reported survey on a 5-point Likert scale (1 = not satisfied at all, 5 = very satisfied). | Baseline to 18 months |
| Number of visits to healthcare providers (HCPs) | Self-reported and verified via medical records when available | Baseline to 18 months |
| Initiation of new statin therapy | Number of participants with newly prescribed statins during follow-up period | Baseline to 18 months |
| Initiation of new antihypertensive therapy | Number of participants with newly prescribed antihypertensive medications during follow-up period | Baseline to 18 months |
| Initiation of new antidiabetic therapy | Number of participants with newly prescribed antidiabetic medications (oral or injectable) during follow-up period | Baseline to 18 months |
| Incidence of new cardiovascular events | Number of participants with new cardiovascular events defined as new diagnosis of myocardial infarction, stroke, or other major adverse cardiovascular event (MACE); verified through clinical records | Baseline to 18 months |
| Incidence of newly diagnosed diabetes mellitus | Number of participants with newly diagnosed type 2 diabetes confirmed by GP or medical record during follow-up | Baseline to 18 months |
| Fribourg |
| Switzerland |
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| 34458905 | Background | Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available. |
| 31504418 | Background | Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available. |
| 27673306 | Background | Silverman MG, Ference BA, Im K, Wiviott SD, Giugliano RP, Grundy SM, Braunwald E, Sabatine MS. Association Between Lowering LDL-C and Cardiovascular Risk Reduction Among Different Therapeutic Interventions: A Systematic Review and Meta-analysis. JAMA. 2016 Sep 27;316(12):1289-97. doi: 10.1001/jama.2016.13985. |
| 23245604 | Background | Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, Abraham J, Adair T, Aggarwal R, Ahn SY, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Barker-Collo S, Bartels DH, Bell ML, Benjamin EJ, Bennett D, Bhalla K, Bikbov B, Bin Abdulhak A, Birbeck G, Blyth F, Bolliger I, Boufous S, Bucello C, Burch M, Burney P, Carapetis J, Chen H, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahodwala N, De Leo D, Degenhardt L, Delossantos A, Denenberg J, Des Jarlais DC, Dharmaratne SD, Dorsey ER, Driscoll T, Duber H, Ebel B, Erwin PJ, Espindola P, Ezzati M, Feigin V, Flaxman AD, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabriel SE, Gakidou E, Gaspari F, Gillum RF, Gonzalez-Medina D, Halasa YA, Haring D, Harrison JE, Havmoeller R, Hay RJ, Hoen B, Hotez PJ, Hoy D, Jacobsen KH, James SL, Jasrasaria R, Jayaraman S, Johns N, Karthikeyan G, Kassebaum N, Keren A, Khoo JP, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lipnick M, Lipshultz SE, Ohno SL, Mabweijano J, MacIntyre MF, Mallinger L, March L, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGrath J, Mensah GA, Merriman TR, Michaud C, Miller M, Miller TR, Mock C, Mocumbi AO, Mokdad AA, Moran A, Mulholland K, Nair MN, Naldi L, Narayan KM, Nasseri K, Norman P, O'Donnell M, Omer SB, Ortblad K, Osborne R, Ozgediz D, Pahari B, Pandian JD, Rivero AP, Padilla RP, Perez-Ruiz F, Perico N, Phillips D, Pierce K, Pope CA 3rd, Porrini E, Pourmalek F, Raju M, Ranganathan D, Rehm JT, Rein DB, Remuzzi G, Rivara FP, Roberts T, De Leon FR, Rosenfeld LC, Rushton L, Sacco RL, Salomon JA, Sampson U, Sanman E, Schwebel DC, Segui-Gomez M, Shepard DS, Singh D, Singleton J, Sliwa K, Smith E, Steer A, Taylor JA, Thomas B, Tleyjeh IM, Towbin JA, Truelsen T, Undurraga EA, Venketasubramanian N, Vijayakumar L, Vos T, Wagner GR, Wang M, Wang W, Watt K, Weinstock MA, Weintraub R, Wilkinson JD, Woolf AD, Wulf S, Yeh PH, Yip P, Zabetian A, Zheng ZJ, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2095-128. doi: 10.1016/S0140-6736(12)61728-0. |
| 34584461 | Background | Wang F, Yu Y, Mubarik S, Zhang Y, Liu X, Cheng Y, Yu C, Cao J. Global Burden of Ischemic Heart Disease and Attributable Risk Factors, 1990-2017: A Secondary Analysis Based on the Global Burden of Disease Study 2017. Clin Epidemiol. 2021 Sep 21;13:859-870. doi: 10.2147/CLEP.S317787. eCollection 2021. |
| Heart Age Calculator | View source |
| Readiness for Change Questionnaire | View source |
| ID | Term |
|---|---|
| D000096442 | Genetic Risk Score |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D020022 | Genetic Predisposition to Disease |
| D004198 | Disease Susceptibility |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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