Cardiovascular DiseasesINNOPREVNCT05883878
Innovative Approaches for Personalised Cardiovascular Prevention
A study testing PRS and Digital app and wearable device in people with Cardiovascular Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 40 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- PRS and Digital app and wearable device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,020 participants
- Where
- 1 siteItaly
- Study dates
- 24 Jul 2023to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- high cardiovascular risk based on the SCORE 2 (between 2.5% and 10%)
- age between 40 and 69 years
Who cannot join
- diabetes.
- familiar hypercholesterolemia.
- established CVD.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Dipartimento Universitario di Scienze della Vita e Sanità Pubblica
Roma, Italia, 00168
Stefania Boccia, 0630154396, stefania.boccia@policlinicogemelli.it
About this study
Official title: Innovative Approaches for Personalised Cardiovascular Prevention: Multicenter Randomised Controlled Study and Multidisciplinary Evaluation for a National Health Service (NHS) Implementation
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
Read more
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.
Read the 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
- Being tested
- PRS, Digital app and wearable device
- Keywords
- Coronary Artery Disease (CAD)
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRSGenetic
genetic test for the evaluation of PRS cardiovascular risk
Digital app and wearable deviceDevice
a wearable device connected with its app
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Participants will receive traditional lifestyle advices in order to reduce the risk. |
| Genetic testing - PRS | Experimental | Participants will receive the information of the genetic cardiovascular risk (PRS) and personalized advices. Receives: Genetic: PRS |
| Digital intervention - app and wearable device | Experimental | Participants will receive an app and a wearable device for the evaluation of various parameters. Receives: Device: Digital app and wearable device |
| Digital intervention and genetic testing - PRS | Experimental | Participants will receive both app and wearable device and PRS information Receives: Genetic: PRS; Device: Digital app and wearable device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start24 Jul 2023
- Primary completionNov 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,020 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University Of Perugia, Policlinic Hospital "G. Rodolico", Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
- Responsible party
- Principal investigator, Boccia Stefania, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883878
- Sponsor's protocol ID
- 5506
- Acronym
- INNOPREV
- Status last verified
- Aug 2025
- First submitted
- 17 May 2023
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35766027
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Approaches for Personalised Cardiovascular Prevention: Multicenter Randomised Controlled Study and Multidisciplinary Evaluation for a National Health Service (NHS) Implementation
- ClinicalTrials.gov ID
- NCT05883878
- Acronym / sponsor ID
- INNOPREV / 5506
- Conditions
- Cardiovascular Diseases
- Keywords
- Coronary Artery Disease (CAD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,020 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- University Of Perugia, Policlinic Hospital "G. Rodolico", Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Participants will receive traditional lifestyle advices in order to reduce the risk. |
| Genetic testing - PRS | Experimental | Genetic: PRSParticipants will receive the information of the genetic cardiovascular risk (PRS) and personalized advices. |
| Digital intervention - app and wearable device | Experimental | Device: Digital app and wearable deviceParticipants will receive an app and a wearable device for the evaluation of various parameters. |
| Digital intervention and genetic testing - PRS | Experimental | Genetic: PRS, Device: Digital app and wearable deviceParticipants will receive both app and wearable device and PRS information |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- high cardiovascular risk based on the SCORE 2 (between 2.5% and 10%)
- age between 40 and 69 years
Key exclusion criteria (3 listed)
- diabetes.
- familiar hypercholesterolemia.
- established CVD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRSgenetic test for the evaluation of PRS cardiovascular risk | Genetic | Digital intervention and genetic testing - PRS, Genetic testing - PRS |
| Digital app and wearable devicea wearable device connected with its app | Device | Digital intervention - app and wearable device, Digital intervention and genetic testing - PRS |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Background: PubMed 35766027Lloyd-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRS and Digital app and wearable device in people with Cardiovascular Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefania Boccia (+390630154396, stefania.boccia@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Lifestyle Category (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05883878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.