Innovative Approaches for Personalised Cardiovascular Prevention
INNOPREV
1 other identifier
interventional
1,020
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cardiovascular-diseases
Started Jul 2023
Typical duration for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2023
CompletedFirst Posted
Study publicly available on registry
June 1, 2023
CompletedStudy Start
First participant enrolled
July 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedAugust 22, 2025
August 1, 2025
2.3 years
May 17, 2023
August 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (4)
Standard of Care
NO INTERVENTIONParticipants will receive traditional lifestyle advices in order to reduce the risk.
Genetic testing - PRS
EXPERIMENTALParticipants will receive the information of the genetic cardiovascular risk (PRS) and personalized advices.
Digital intervention - app and wearable device
EXPERIMENTALParticipants will receive an app and a wearable device for the evaluation of various parameters.
Digital intervention and genetic testing - PRS
EXPERIMENTALParticipants will receive both app and wearable device and PRS information
Interventions
genetic test for the evaluation of PRS cardiovascular risk
a wearable device connected with its app
Eligibility Criteria
You may qualify if:
- high cardiovascular risk based on the SCORE 2 (between 2.5% and 10%)
- age between 40 and 69 years
You may not qualify if:
- diabetes.
- familiar hypercholesterolemia.
- established CVD.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dipartimento Universitario di Scienze della Vita e Sanità Pubblica
Roma, Italia, 00168, Italy
Related 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.
PMID: 35766027BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor of Hygiene and Preventive Medicine
Study Record Dates
First Submitted
May 17, 2023
First Posted
June 1, 2023
Study Start
July 24, 2023
Primary Completion
November 1, 2025
Study Completion
May 1, 2026
Last Updated
August 22, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share