Epidemiology of Cardiovascular RiskSKIMNCT03962309
Selection of People at Low Cardiovascular Risk: Development of an Inexpensive Pre-screening Algorithm Using Only Non-laboratory Measures. The SKIM Risk Study.
An observational study of Epidemiology of Cardiovascular Risk, run by Mario Negri Institute for Pharmacological Research at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 69 years
- Conditions the study is for
- Epidemiology of Cardiovascular Risk
- What is being tested?
- Health self-assessment questionnaire
- How many people
- 2,699 participants
- Where
- 3 sitesItaly
- Study dates
- 18 Dec 2020to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects aged 40-70 years in charge of GPs, giving the consent to partecipate in the study
Who may be able to join
- Subjects aged 40-70 years
Who cannot join
- Patients with previous cardiovascular events
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Cooperativa Medici Milano Centro
Milan
Cooperativa Nucleo Cure Primarie Val Pescara
Pescara
Cooperativa Medici 2000
Siena
About this study
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.
Read the 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.
- Conditions
- Epidemiology of Cardiovascular Risk
- Being tested
- Health self-assessment questionnaire
- Keywords
- Screening, General Practice, Self Assessment, Algorithms for risk stratification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health self-assessment questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients in charge of the participating GPs | In the study will be included patients in charge of the participating GPs aged 40-70 years Receives: Other: Health self-assessment questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (10)
Race
Questions about the ethnic origin will be asked
Measured: 1 day
Marital status
Questions about the marital status will be asked
Measured: 1 day
Education status
Questions about the educational attainment will be asked
Measured: 1 day
Employment status
Questions about the employment will be asked
Measured: 1 day
Clinical Family History
Questions about the family health history will be asked
Measured: 1 day
Personal Clinical History
Questions about the personal health history will be asked
Measured: 1 day
The dietary habits
Questions about diet, alcohol consumption and salt consumption will be asked.
Measured: 1 day
Physical activity
Questions about physical activity usually practiced will be asked
Measured: 1 day
Smoking habits
Questions about smoking habits will be asked
Measured: 1 day
Behavioral domain
Questions about aspects of the behavioral domain will be asked
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start18 Dec 2020
- Primary completion30 Jun 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidemiology of Cardiovascular RiskStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,699 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Cardiologico Monzino, IRCCS Multimedica
- Responsible party
- Sponsor
- Investigators
- Roberto Latini, MD, Principal investigator, Istituto Di Ricerche Farmacologiche Mario Negri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962309
- Sponsor's protocol ID
- IRFMN-7307
- Acronym
- SKIM
- Status last verified
- May 2025
- First submitted
- 21 May 2019
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03962309
- Acronym / sponsor ID
- SKIM / IRFMN-7307
- Conditions
- Epidemiology of Cardiovascular Risk
- Keywords
- Screening, General Practice, Self Assessment, Algorithms for risk stratification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,699 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- Centro Cardiologico Monzino, IRCCS Multimedica
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in charge of the participating GPs | – | Other: Health self-assessment questionnaireIn the study will be included patients in charge of the participating GPs aged 40-70 years |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects aged 40-70 years in charge of GPs, giving the consent to partecipate in the study
Key inclusion criteria (1 listed)
- Subjects aged 40-70 years
Key exclusion criteria (1 listed)
- Patients with previous cardiovascular events
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health self-assessment questionnaireThe 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. | Other | Patients in charge of the participating GPs |
Primary outcome
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.
10 secondary outcomes
Race
Time frame: 1 day
Marital status
Time frame: 1 day
Education status
Time frame: 1 day
Employment status
Time frame: 1 day
Clinical Family History
Time frame: 1 day
Personal Clinical History
Time frame: 1 day
The dietary habits
Time frame: 1 day
Physical activity
Time frame: 1 day
Smoking habits
Time frame: 1 day
Behavioral domain
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Latini, MD principal investigator
Istituto Di Ricerche Farmacologiche Mario Negri
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidemiology of Cardiovascular Risk, run by Mario Negri Institute for Pharmacological Research at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To develop of a low cost CVD risk score (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.