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

NCT03962309 | Completed

• 1 other identifier: IRFMN-7307
• Study Type: observational
• Target: 2,699
• Locations: 1 country
• Sites: 3

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.

Conditions

Epidemiology of Cardiovascular Risk

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Race

  1 day

• Marital status

  1 day

• Education status

  1 day

• Employment status

  1 day

• Clinical Family History

  1 day

Study Arms (1)

Patients in charge of the participating GPs

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

Other: Health self-assessment questionnaire

Interventions

Health self-assessment questionnaire 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.

Patients in charge of the participating GPs

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects aged 40-70 years in charge of GPs, giving the consent to partecipate in the study

You may qualify if:

• Subjects aged 40-70 years

You may not qualify if:

• Patients with previous cardiovascular events

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead
• Centro Cardiologico Monzino: collaborator
• IRCCS Multimedica: collaborator

Study Sites (3)

Cooperativa Medici Milano Centro

Milan, Italy

Location

Cooperativa Nucleo Cure Primarie Val Pescara

Pescara, Italy

Location

Cooperativa Medici 2000

Siena, Italy

Location

Study Officials

• Roberto Latini, MD

  Istituto Di Ricerche Farmacologiche Mario Negri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 24, 2019
• Study Start: December 18, 2020
• Primary Completion: June 30, 2024
• Study Completion: August 31, 2024
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

IT (3)