Innovative Approaches for Personalised Cardiovascular Prevention

Cardiovascular Diseases Clinical Trial

— INNOPREV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05883878
• Other study ID #: 5506
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: May 2025

Study information

• Verified date: September 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Stefania Boccia
• Phone: +390630154396
• Email: stefania.boccia[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1020
• Est. completion date: May 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Genetic:
• PRS
genetic test for the evaluation of PRS cardiovascular risk

Device:
• Digital app and wearable device
a wearable device connected with its app

Locations

Country	Name	City	State
Italy	Dipartimento Universitario di Scienze della Vita e Sanità Pubblica	Roma	Italia

Sponsors (4)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo, Policlinic Hospital "G. Rodolico", Università degli Studi di Perugia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	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.	12 months