Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Of Perugia | OTHER |
| Policlinic Hospital "G. Rodolico" | OTHER |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo | OTHER |
Not provided
Not provided
Not provided
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:
Participants will be randomized in one of the four parallel arms:
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.
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:
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Digital intervention - app and wearable device | Experimental | Participants will receive an app and a wearable device for the evaluation of various parameters. |
|
| Digital intervention and genetic testing - PRS | Experimental | Participants will receive both app and wearable device and PRS information |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRS | Genetic | genetic test for the evaluation of PRS cardiovascular risk |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefania Boccia | Contact | +390630154396 | stefania.boccia@policlinicogemelli.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dipartimento Universitario di Scienze della Vita e Sanità Pubblica | Recruiting | Roma | Italia | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35766027 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
Not provided
Not provided
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| ID | Term |
|---|---|
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Digital app and wearable device | Device | a wearable device connected with its app |
|
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |