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

March 13, 2024 updated by: Mario Negri Institute for Pharmacological Research
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milano, Italy
        • Recruiting
        • Cooperativa Medici Milano Centro
        • Contact:
          • Alberto Aronica
        • Principal Investigator:
          • Alberto Aronica
      • Pescara, Italy
        • Recruiting
        • Cooperativa Nucleo Cure Primarie Val Pescara
        • Contact:
          • Silvio Basile
        • Principal Investigator:
          • Silvio Basile
      • Siena, Italy
        • Recruiting
        • Cooperativa Medici 2000
        • Contact:
          • Maurizio Pozzi
        • Principal Investigator:
          • Maurizio Pozzi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Subjects aged 40-70 years

Exclusion Criteria:

  • Patients with previous cardiovascular events

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To develop of a low cost CVD risk score
Time Frame: 1 day
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mario Negri Institute for Pharmacological Research

Collaborators

IRCCS Multimedica
Centro Cardiologico Monzino

Investigators

  • Principal Investigator: Roberto Latini, MD, Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2020

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

May 21, 2019

First Submitted That Met QC Criteria

May 22, 2019

First Posted (Actual)

May 24, 2019

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRFMN-7307

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epidemiology of Cardiovascular Risk

Clinical Trials on Health self-assessment questionnaire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe