Clinical trial NCT03962309: Selection of People at Low Cardiovascular Risk: Development of an Inexpensive Pre-screening Algorithm Using Only Non-laboratory Measures. The SKIM Risk Study.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epidemiology of Cardiovascular Risk
Keywords: Screening
General Practice
Self Assessment
Algorithms for risk stratification
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
Collaborators: name: Centro Cardiologico Monzino
name: IRCCS Multimedica
First posted: 2019-05-24
Enrollment: 2699
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects aged 40-70 years in charge of GPs, giving the consent to partecipate in the study

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.

Eligibility criteria: Inclusion Criteria:

* Subjects aged 40-70 years

Exclusion Criteria:

* Patients with previous cardiovascular events

Primary outcomes:
measure: To develop of a low cost CVD risk score
timeFrame: 1 day
Secondary outcomes:
measure: Race
timeFrame: 1 day
measure: Marital status
timeFrame: 1 day
measure: Education status
timeFrame: 1 day
measure: Employment status
timeFrame: 1 day
measure: Clinical Family History
timeFrame: 1 day
measure: Personal Clinical History
timeFrame: 1 day
measure: The dietary habits
timeFrame: 1 day
measure: Physical activity
timeFrame: 1 day
measure: Smoking habits
timeFrame: 1 day
measure: Behavioral domain
timeFrame: 1 day
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Cooperativa Medici Milano Centro
city: Pescara
country: Italy
facility: Cooperativa Nucleo Cure Primarie Val Pescara
city: Siena
country: Italy
facility: Cooperativa Medici 2000
Study officials:
affiliation: Istituto Di Ricerche Farmacologiche Mario Negri
name: Roberto Latini, MD
role: PRINCIPAL_INVESTIGATOR
References: