Innovative Approaches for Personalised Cardiovascular Prevention

Study Overview
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Brief Summary
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The goal of this clinical trial is to study innovative approaches for personalized primary preventive interventions for cardiovascular diseases (CVD) in the population. The main questions it aims to answer are: efficacy and safety of the intervention how to implement the interventions in the NHS Participants will be randomized in one of the four parallel arms: standard of care; genetic testing for cardiovascular genetic risk (through the cardiovascular Polygenic Risk Score or PRS); digital intervention with a wearable device and its app; digital intervention and genetic testing (PRS) The primary outcome we are going to evaluate is the efficacy of returning PRS information of CVD measured at baseline, alone or in combination with the use of a wearable device, on two endpoints: i) change in lifestyle pattern; ii) CVD risk profile modification. The postulated hypothesis is that the achievement of these endpoints is more likely in presence of at least one of the aforementioned interventions than among subjects who receive only traditional risk assessment at baseline, nor respect to subjects receiving traditional risk assessment plus adopting wearable devices.

Detailed Description
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The trial will consist of four phases: an enrollment phase (T0), a disclosure visit three weeks later (T1), a follow-up visit five months after the disclosure visit (T2), and a final follow-up twelve months from enrollment (T3). Once enrolled (T0), all participants will sign the informed consent form and undergo a comprehensive assessment, which includes: Completing a questionnaire on socioeconomic status, area of residence, and lifestyle, using the Life's Essential 8 tool [1]. The questionnaire will cover smoking status, alcohol consumption, dietary pattern, sleep pattern, and physical activity. Participants will be classified into favorable, intermediate, or unfavorable individual lifestyle patterns according to the Life's Essential 8 score. Blood analysis will be performed to evaluate the lipid profile, including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. At T1, a disclosure visit will be conducted to explain the assigned lifestyle category, share the results of the blood tests, and provide information on the expected interventions based on the assigned group. The questionnaire will be administered at T0, T2, and T3. Blood analysis and cardiovascular profile evaluation will be conducted at both T0 and T3

Official Title
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Innovative Approaches for Personalised Cardiovascular Prevention: Multicenter Randomised Controlled Study and Multidisciplinary Evaluation for a National Health Service (NHS) Implementation

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Genetic: PRS
* Device: Digital app and wearable device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: high cardiovascular risk based on the SCORE 2 (between 2.5% and 10%) age between 40 and 69 years Exclusion Criteria: diabetes. familiar hypercholesterolemia. established CVD.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Participants will receive traditional lifestyle advices in order to reduce the risk. | |
| Experimental: Genetic testing - PRS<br>Participants will receive the information of the genetic cardiovascular risk (PRS) and personalized advices. | Genetic: PRS<br>* genetic test for the evaluation of PRS cardiovascular risk<br>|
| Experimental: Digital intervention - app and wearable device<br>Participants will receive an app and a wearable device for the evaluation of various parameters. | Device: Digital app and wearable device<br>* a wearable device connected with its app<br>|
| Experimental: Digital intervention and genetic testing - PRS<br>Participants will receive both app and wearable device and PRS information | Genetic: PRS<br>* genetic test for the evaluation of PRS cardiovascular risk<br>Device: Digital app and wearable device<br>* a wearable device connected with its app<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Lifestyle Category | The lifestyle category will be measured using the Life's Essential 8 tool. A change will be considered achieved if there is a shift towards a more favorable lifestyle category. | 12 months | 
| Modification of the Lipid Profile | We will evaluate whether there is a change in the lipid profile compared to the baseline value. The modification of the lipid profile can also be considered as an indicator of the modification of the cardiovascular risk profile measured with the SCORE 2 charts. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease (CAD)