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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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ClinicalTrials.gov Identifier: NCT03962309
Recruitment Status : Not yet recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Sponsor:
Collaborators:
Centro Cardiologico Monzino
IRCCS Multimedica
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

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.

Condition or disease Intervention/treatment
Epidemiology of Cardiovascular Risk Other: Health self-assessment questionnaire

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.


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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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.
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : October 1, 2022

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Race [ Time Frame: 1 day ]
    Questions about the ethnic origin will be asked

  2. Marital status [ Time Frame: 1 day ]
    Questions about the marital status will be asked

  3. Education status [ Time Frame: 1 day ]
    Questions about the educational attainment will be asked

  4. Employment status [ Time Frame: 1 day ]
    Questions about the employment will be asked

  5. Clinical Family History [ Time Frame: 1 day ]
    Questions about the family health history will be asked

  6. Personal Clinical History [ Time Frame: 1 day ]
    Questions about the personal health history will be asked

  7. The dietary habits [ Time Frame: 1 day ]
    Questions about diet, alcohol consumption and salt consumption will be asked.

  8. Physical activity [ Time Frame: 1 day ]
    Questions about physical activity usually practiced will be asked

  9. Smoking habits [ Time Frame: 1 day ]
    Questions about smoking habits will be asked

  10. Behavioral domain [ Time Frame: 1 day ]
    Questions about aspects of the behavioral domain will be asked



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

Inclusion Criteria:

  • Subjects aged 40-70 years

Exclusion Criteria:

  • Patients with previous cardiovascular events

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962309


Contacts
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Contact: Maria Carla Roncaglioni, MSc +390239014 ext 481 carla.roncaglioni@marionegri.it
Contact: Irene Marzona, PharmD +3939014 ext 561 irene.marzona@marionegri.it

Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Centro Cardiologico Monzino
IRCCS Multimedica
Investigators
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Principal Investigator: Roberto Latini, MD Istituto di Ricerche Farmacologiche Mario Negri IRCCS

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Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT03962309     History of Changes
Other Study ID Numbers: IRFMN-7307
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mario Negri Institute for Pharmacological Research:
Screening
General Practice
Self Assessment
Algorithms for risk stratification