Innovative Approaches for Personalised Cardiovascular Prevention

NCT ID: NCT05883878

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1020 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-24
• Study Completion Date: 2026-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard of Care

Participants will receive traditional lifestyle advices in order to reduce the risk.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Genetic testing - PRS

Participants will receive the information of the genetic cardiovascular risk (PRS) and personalized advices.

Group Type: EXPERIMENTAL

PRS

Intervention Type: GENETIC

genetic test for the evaluation of PRS cardiovascular risk

Digital intervention - app and wearable device

Participants will receive an app and a wearable device for the evaluation of various parameters.

Group Type: EXPERIMENTAL

Digital app and wearable device

Intervention Type: DEVICE

a wearable device connected with its app

Digital intervention and genetic testing - PRS

Participants will receive both app and wearable device and PRS information

Group Type: EXPERIMENTAL

PRS

Intervention Type: GENETIC

genetic test for the evaluation of PRS cardiovascular risk

Digital app and wearable device

Intervention Type: DEVICE

a wearable device connected with its app

Interventions

PRS

genetic test for the evaluation of PRS cardiovascular risk

Intervention Type: GENETIC

Digital app and wearable device

a wearable device connected with its app

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Of Perugia

OTHER

Sponsor Role: collaborator

Policlinic Hospital "G. Rodolico"

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

OTHER

Sponsor Role: collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Boccia Stefania

Full Professor of Hygiene and Preventive Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dipartimento Universitario di Scienze della Vita e Sanità Pubblica

Roma, Italia, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Stefania Boccia

Role: CONTACT

stefania.boccia@policlinicogemelli.it

+390630154396

Facility Contacts

Stefania Boccia

Role: primary

stefania.boccia@policlinicogemelli.it

0630154396

References

Lloyd-Jones DM, Allen NB, Anderson CAM, Black T, Brewer LC, Foraker RE, Grandner MA, Lavretsky H, Perak AM, Sharma G, Rosamond W; American Heart Association. Life's Essential 8: Updating and Enhancing the American Heart Association's Construct of Cardiovascular Health: A Presidential Advisory From the American Heart Association. Circulation. 2022 Aug 2;146(5):e18-e43. doi: 10.1161/CIR.0000000000001078. Epub 2022 Jun 29.

Reference Type: BACKGROUND

PMID: 35766027 (View on PubMed)

Other Identifiers

5506

Identifier Type: -

Identifier Source: org_study_id