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NCT Number: NCT05883878

Innovative Approaches for Personalised Cardiovascular 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:

* 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.

Recruiting

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Key information

Conditions

Cardiovascular Diseases Arterial Occlusive Diseases Arteriosclerosis Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

40 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dipartimento Universitario di Scienze della Vita e Sanità Pubblica

Roma, Italia, 00168, Italy

Location status: Recruiting

Location contact

Stefania Boccia

CONTACT

[email protected]

0630154396

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRS

Genetic

genetic test for the evaluation of PRS cardiovascular risk

Digital app and wearable device

Device

a wearable device connected with its app

Primary outcomes

  1. Change in the Lifestyle Category

    Time frame: 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.

  2. Modification of the Lipid Profile

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stefania Boccia

CONTACT

[email protected]

+390630154396

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
  • Policlinic Hospital "G. Rodolico"
  • University Of Perugia

Registry information

Official study title

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

Acronym: INNOPREV

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 1, 2023
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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