NCT03962309|Completed
Selection of People at Low Cardiovascular Risk: Development of an Inexpensive Pre-screening Algorithm Using Only Non-laboratory Measures. The SKIM Risk Study.
SKIM
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SKIM
Sponsor study identifier
observational
2,699
1 country
3
Study Start
December 18, 2020
Actual (reported)Primary Completion
June 30, 2024
Actual (reported)Study Completion
August 31, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 21, 2019
Actual (reported)May 24, 2019
Actual (reported)December 18, 2020
Actual (reported)June 30, 2024
Actual (reported)August 31, 2024
Actual (reported)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
Race
1 day
Marital status
1 day
Education status
1 day
Employment status
1 day
Clinical Family History
1 day
In the study will be included patients in charge of the participating GPs aged 40-70 years
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Subjects aged 40-70 years in charge of GPs, giving the consent to partecipate in the study
Cooperativa Medici Milano Centro
Milan, Italy
Cooperativa Nucleo Cure Primarie Val Pescara
Pescara, Italy
Cooperativa Medici 2000
Siena, Italy
Roberto Latini, MD
Istituto Di Ricerche Farmacologiche Mario Negri
2,699 participants (actual enrollment reported by the registry).
First Submitted
May 21, 2019
First Posted
May 24, 2019
Study Start
December 18, 2020
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
June 30, 2024
Actual (reported)Study Completion
August 31, 2024
Actual (reported)Last Updated
May 7, 2025
Record last verified: 2025-05
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Source: ClinicalTrials.gov.
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