Personalized prevention strategies for cardiovascular diseases
Innovative Approaches for Personalised Cardiovascular Prevention: Multicenter Randomised Controlled Study and Multidisciplinary Evaluation for a National Health Service (NHS) Implementation
This study is testing different ways to prevent heart disease by comparing standard care, genetic testing, a digital device, and a mix of both to see which works best for people.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1020 (estimated) |
| Ages | 40 Years to 69 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, Italia) |
| Trial ID | NCT05883878 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to explore innovative personalized primary preventive interventions for cardiovascular diseases by comparing four different approaches: standard care, genetic testing for cardiovascular risk, a digital intervention using a wearable device, and a combination of both genetic testing and digital intervention. Participants will be randomized into one of these four groups and will undergo assessments at multiple time points to evaluate changes in lifestyle patterns and cardiovascular risk profiles. The study will also investigate the efficacy and safety of these interventions and how they can be implemented within the NHS.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 40 to 69 years with a high cardiovascular risk based on the SCORE 2 assessment.
Not a fit: Patients with diabetes, familial hypercholesterolemia, or established cardiovascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective personalized prevention strategies for individuals at high risk of cardiovascular diseases.
How similar studies have performed: Other studies have shown promise in using genetic testing and digital interventions for cardiovascular risk management, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Roma, Italia
- Dipartimento Universitario di Scienze della Vita e Sanità Pubblica — Roma, Italia, Italy (Recruiting)
Study contacts
- Study coordinator: Stefania Boccia
- Email: stefania.boccia@policlinicogemelli.it
- Phone: +390630154396
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.