Innovative Approaches for Personalised Cardiovascular Prevention

Condition(s) studied

Investigational drug(s) / intervention(s)

PRS: genetic test for the evaluation of PRS cardiovascular risk

Digital app and wearable device: a wearable device connected with its app

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in the Lifestyle Category — 12 months
  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.
• Modification of the Lipid Profile — 12 months
  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.

Trial sites (1)

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