NCT05883878

Innovative Approaches for Personalised Cardiovascular Prevention

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,020 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 40 Years – 69 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
GENETIC	PRS	genetic test for the evaluation of PRS cardiovascular risk
DEVICE	Digital app and wearable device	a wearable device connected with its app

Timeline

• Start date: 2023-07-24
• Primary completion: 2025-11-01
• Completion: 2026-05-01
• First posted: 2023-06-01
• Last updated: 2025-08-22

Locations

1 site across 1 country: Italy