Innovative Approaches for Personalised Cardiovascular Prevention (INNOPREV)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Cardiovascular Diseases

Treatments: Genetic: PRS; Device: Digital app and wearable device

Study type: Interventional

Funder types: Other

Identifiers

NCT05883878

5506

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,020 estimated patients

Sex: All

Ages: 40 to 69 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,020 participants in 4 patient groups

Standard of Care

No Intervention group

Description:

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

Genetic testing - PRS

Experimental group

Description:

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

Treatment:

Genetic: PRS

Digital intervention - app and wearable device

Experimental group

Description:

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

Treatment:

Device: Digital app and wearable device

Digital intervention and genetic testing - PRS

Experimental group

Description:

Participants will receive both app and wearable device and PRS information

Treatment:

Device: Digital app and wearable device

Genetic: PRS