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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.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03962309
Acronym
SKIM
Enrollment
2699
Registered
2019-05-24
Start date
2020-12-18
Completion date
2024-08-31
Last updated
2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidemiology of Cardiovascular Risk

Keywords

Screening, General Practice, Self Assessment, Algorithms for risk stratification

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.

Interventions

OTHERHealth 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.

Sponsors

Centro Cardiologico Monzino
CollaboratorOTHER
IRCCS Multimedica
CollaboratorOTHER
Mario Negri Institute for Pharmacological Research
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to 69 Years
Healthy volunteers
No

Inclusion criteria

* Subjects aged 40-70 years

Exclusion criteria

* Patients with previous cardiovascular events

Design outcomes

Primary

MeasureTime frameDescription
To develop of a low cost CVD risk score1 dayThe 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.

Secondary

MeasureTime frameDescription
Race1 dayQuestions about the ethnic origin will be asked
Education status1 dayQuestions about the educational attainment will be asked
Employment status1 dayQuestions about the employment will be asked
Clinical Family History1 dayQuestions about the family health history will be asked
Marital status1 dayQuestions about the marital status will be asked
The dietary habits1 dayQuestions about diet, alcohol consumption and salt consumption will be asked.
Physical activity1 dayQuestions about physical activity usually practiced will be asked
Smoking habits1 dayQuestions about smoking habits will be asked
Behavioral domain1 dayQuestions about aspects of the behavioral domain will be asked
Personal Clinical History1 dayQuestions about the personal health history will be asked

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026