- ICH GCP
- US Clinical Trials Registry
- 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. (SKIM)
Study Overview
Status
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Maria Carla Roncaglioni, MSc
- Phone Number: 481 +390239014
- Email: carla.roncaglioni@marionegri.it
Study Contact Backup
- Name: Irene Marzona, PharmD
- Phone Number: 561 +3939014
- Email: irene.marzona@marionegri.it
Study Locations
-
-
-
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects aged 40-70 years
Exclusion Criteria:
- Patients with previous cardiovascular events
Study Plan
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
|
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
Investigators
- Principal Investigator: Roberto Latini, MD, Istituto di Ricerche Farmacologiche Mario Negri IRCCS
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRFMN-7307
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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