An observational study in Epidemiology of Cardiovascular Risk, sponsored by Mario Negri Institute for Pharmacological Research. Completed at 3 sites in Italy. Open to participants aged 40 Years to 69 Years. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by Mario Negri Institute for Pharmacological Research · Observational
Early identification of individuals at high risk remains the cornerstone of primary cardiovascular prevention (CV). However, cardiovascular screening including people at low CV diseases (CVD) risk are too costly, time consuming and poorly effective in reducing incident CV events to be proposed at population level. Thus, innovative tools that allow to exclude low risk subjects in order to concentrate the relatively poor resources of NHS for primary prevention in high risk groups are needed. In this study, we will assess whether a new low cost strategy for CV risk stratification, based on non-laboratory measures, will allow to recognize low risk subjects who do not need further and expensive measures. To this end, we will take advantage of a General Practitioners (GPs) national network that will allow to work in the natural contest of primary prevention. If successful, the project will provide the basis for future, cost-effective prevention programs to be performed at national level.
National, multicenter cross-sectional study.
The current study will be performed as part of Italian Cardiology Network implemented by the Italian Ministry of Health.
This study will be carried out with the collaboration with Study Center for Primary Care.
A random sample of subjects identified by the list of patients in charge of the participating GPs aged 40-70 years will be invited to a screening for the evaluation of their CV risk.
All patients who agree to participate in the study and sign the consent will complete a health self-assessment questionnaire which includes questions covering anthropometric, sociodemographics, personal and family health history, life style habits and aspects of the behavioral domain.
This will be followed by biometric measurements including height, weight and waist circumference conducted at the consulting room of the GP by certified staff. Informative predictors, selected among all variables selected, will be identified by a stepwise multivariable logistic regression. The low risk CV score will be calculated as the sum of the coefficients of the retained variables.
Mario Negri Institute for Pharmacological Research is the lead sponsor of 159 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects aged 40-70 years in charge of GPs, giving the consent to partecipate in the study
Exclusion Criteria:
In the study will be included patients in charge of the participating GPs aged 40-70 years
Other: Health self-assessment questionnaire
The health self-assessment questionnaire includes questions covering anthropometric, sociodemographics, personal and family health history, life style habits and aspects of the behavioral domain. The questionnaire will be administered as paper format or web-based electronic format according to participants' preferences.
To develop of a low cost CVD risk score
The low cost CVD risk score will be developed using variable obtainable only by the self-assessment questionnaire (low-cost) to identify persons at low CVD risk according to Progetto CUORE or SCORE risk estimation.
Time frame: 1 day
Race
Questions about the ethnic origin will be asked
Time frame: 1 day
Marital status
Questions about the marital status will be asked
Time frame: 1 day
Education status
Questions about the educational attainment will be asked
Time frame: 1 day
Employment status
Questions about the employment will be asked
Time frame: 1 day
Clinical Family History
Questions about the family health history will be asked
Time frame: 1 day
Personal Clinical History
Questions about the personal health history will be asked
Time frame: 1 day
The dietary habits
Questions about diet, alcohol consumption and salt consumption will be asked.
Time frame: 1 day
Physical activity
Questions about physical activity usually practiced will be asked
Time frame: 1 day
Smoking habits
Questions about smoking habits will be asked
Time frame: 1 day
Behavioral domain
Questions about aspects of the behavioral domain will be asked
Time frame: 1 day
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Mario Negri Institute for Pharmacological Research