Selection of People at Low Cardiovascular Risk: Development of an Inexpensive Pre-screening Algorithm Using Only Non-laboratory Measures. The SKIM Risk Study.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Selection of People at Low Cardiovascular Risk: Development of an Inexpensive Pre-screening Algorithm Using Only Non-laboratory Measures. The SKIM Risk Study.

Conditions
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Epidemiology of Cardiovascular Risk

Intervention / Treatment
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* Other: Health self-assessment questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged 40-70 years Exclusion Criteria: Patients with previous cardiovascular events

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients in charge of the participating GPs<br>In the study will be included patients in charge of the participating GPs aged 40-70 years | Other: Health self-assessment questionnaire<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Race | Questions about the ethnic origin will be asked | 1 day | 
| Marital status | Questions about the marital status will be asked | 1 day | 
| Education status | Questions about the educational attainment will be asked | 1 day | 
| Employment status | Questions about the employment will be asked | 1 day | 
| Clinical Family History | Questions about the family health history will be asked | 1 day | 
| Personal Clinical History | Questions about the personal health history will be asked | 1 day | 
| The dietary habits | Questions about diet, alcohol consumption and salt consumption will be asked. | 1 day | 
| Physical activity | Questions about physical activity usually practiced will be asked | 1 day | 
| Smoking habits | Questions about smoking habits will be asked | 1 day | 
| Behavioral domain | Questions about aspects of the behavioral domain will be asked | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, General Practice, Self Assessment, Algorithms for risk stratification