Evaluating new methods for predicting cardiovascular disease risk in Italy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The CVRISK-IT study investigates the health benefits of incorporating genetic and imaging risk information for individuals at low-to-moderate or high risk of cardiovascular diseases (CVD) in Italy. This multicenter, open randomized trial will recruit healthy participants aged 40 to 80 years from various primary care settings and assess their risk using SCORE2/SCORE2-OP models. Those identified as low-to-moderate or high risk will be randomized into groups receiving different levels of risk information alongside lifestyle advice and medical treatment. The study also aims to create a bioresource for future research on chronic diseases in the Italian population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age: 40-80 years
* Apparently healthy individuals without previous medical history of CVD or diabetes (based on medical diagnosis)
* Participant recruitment arranged only at selected IRCCS (and associated Spokes) as part of the 'Rete Cardiologica'
* Participants must have signed the Informed Consent and Data Privacy Treatment forms
* Participants must have a personal e-mail address and internet connection

Exclusion Criteria:

* Age ≤40 or ≥80 years
* Individuals have previous medical history related to CVD (e.g., heart failure, congenital heart disorder, coronary heart disease) based on medical diagnosis
* Candidates have previously participated in clinical studies of 'Rete Cardiologica' (e.g., PREVITAL)
* Medical diagnosis of mental disorders
* Pregnancy based on self-reported information
* Previous history of type 1 or type 2 diabetes (based on medical diagnosis)
* Oncology patients (based on physician indication)

Where it's running

• Irccs Inrca
  Ancona, Italy Recruiting
• IRCCS Auxologico Italiano
  Milan, Italy Recruiting
• IRCCS Cardiologico Monzino
  Milan, Italy Recruiting
• IRCCS Mario Negri
  Milan, Italy Recruiting
• IRCCS Multimedica
  Milan, Italy Recruiting
• IRCCS Ospedale San Raffaele
  Milan, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.