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

Epidemiology of Cardiovascular Risk Clinical Trial

— SKIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03962309
• Other study ID #: IRFMN-7307
• Status: Recruiting
• Start date: December 18, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: Mario Negri Institute for Pharmacological Research
• Contact: Maria Carla Roncaglioni, MSc
• Phone: +390239014
• Email: carla.roncaglioni[@]marionegri.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: August 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 69 Years

Eligibility

Inclusion Criteria:

• Subjects aged 40-70 years

Exclusion Criteria:

• Patients with previous cardiovascular events

Related Conditions & MeSH terms

• Epidemiology of Cardiovascular Risk

Intervention

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.

Locations

Country	Name	City	State
Italy	Cooperativa Medici Milano Centro	Milano
Italy	Cooperativa Nucleo Cure Primarie Val Pescara	Pescara
Italy	Cooperativa Medici 2000	Siena

Sponsors (3)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research	Centro Cardiologico Monzino, IRCCS Multimedica

Country where clinical trial is conducted

Italy, 

Outcome

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