An interventional study of PRS and Digital app and wearable device in Cardiovascular Diseases, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 40 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Prevention
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:
Participants will be randomized in one of the four parallel arms:
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.
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:
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
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's planned enrollment of 1,020 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive traditional lifestyle advices in order to reduce the risk.
Participants will receive the information of the genetic cardiovascular risk (PRS) and personalized advices.
Genetic: PRS
Participants will receive an app and a wearable device for the evaluation of various parameters.
Device: Digital app and wearable device
Participants will receive both app and wearable device and PRS information
Genetic: PRS · Device: Digital app and wearable device
genetic test for the evaluation of PRS cardiovascular risk
a wearable device connected with its app
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.
Time frame: 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.
Time frame: 12 months
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS