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

NCT ID: NCT03962309

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2699 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-18
• Study Completion Date: 2024-08-31

Brief Summary

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

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.

Conditions

Epidemiology of Cardiovascular Risk

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients in charge of the participating GPs

In the study will be included patients in charge of the participating GPs aged 40-70 years

Health self-assessment questionnaire

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subjects aged 40-70 years

Exclusion Criteria

• Patients with previous cardiovascular events

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Cardiologico Monzino

OTHER

Sponsor Role: collaborator

IRCCS Multimedica

OTHER

Sponsor Role: collaborator

Mario Negri Institute for Pharmacological Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberto Latini, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Di Ricerche Farmacologiche Mario Negri

Locations

Cooperativa Medici Milano Centro

Milan, , Italy

Cooperativa Nucleo Cure Primarie Val Pescara

Pescara, , Italy

Cooperativa Medici 2000

Siena, , Italy

Countries

Italy

Other Identifiers

IRFMN-7307

Identifier Type: -

Identifier Source: org_study_id