Cardiovascular DiseasesCV-RPNCT06190743
Perception of Cardiovascular Risk
An observational study of Cardiovascular Diseases and Heart Diseases, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site in Italy.
Trial summary
The aim of the study is to describe the association between the perception of cardiovascular (CV) risk and the actual CV risk and, secondarily, to detect the actual CV risk to assess the prevalence of clinical risk factors, determined by means of appropriate instruments. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- What is being tested?
- Prevention events organized by participating centers
- How many people
- 271 participants
- Where
- 1 siteItaly
- Study dates
- 29 Sep 2023to Sep 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 18 to 69 years
- All sexes
- Adult, Older adult
Study population: Convenience sample of adult subjects who voluntarily wish to participate in prevention events and who will be asked for consent to participate
Who may be able to join
- an age between 18 and 69 years of age
- subscription to informed consent.
Who cannot join
- patients with a positive history of hospitalization due to CV pathology at the time of enrollment;
- patients with ongoing relevant cognitive debilitation (Six Item Screener score < 4)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
Alessandria, Piedmont, 15121
About this study
Official title: Perception of Cardiovascular Risk: Description of the Phenomenon in Primary Prevention
The aim of the study is to describe the association between the perception of cardiovascular (CV) risk and the actual CV risk and, secondarily, to detect the actual CV risk to assess the prevalence of clinical risk factors, determined by means of appropriate instruments.
Read the detailed description
Cardiovascular (CV) disease is the major cause of premature death in adults that carries serious economic consequences.
Risk perception for CV disease has been reported as the subjective judgment of the likelihood of having a CV event. Risk perception is an important precursor to adopting a healthy lifestyle. However, both overestimation and underestimation of actual risk due mostly to poor health literacy are common.
For these reasons, CV prevention services of health care professionals (e.g., nurses, physicians) should, on the one hand, include screening for the presence of risk factors, and on the other hand, know the CV risk perceptions of those being cared for.
The aim of the study is to describe the association between the perception of cardiovascular (CV) risk, investigated by means of the Perception of Risk of Heart Disease Scale and a Likert-5 scale question, and the actual CV risk according to the SCORE2 and, secondarily, to detect the actual CV risk ascertained by the SCORE2 and to assess the prevalence of clinical risk factors (alterations in the lipid, glucose, or anthropometric profile) determined by means of appropriate instruments.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Being tested
- Prevention events organized by participating centers
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention events organized by participating centersOther
Cardiovascular disease primary prevention events organized by centers participating in the study where capillary sampling will be performed on subjects to quantify plasma levels of cardiovascular risk factors and validated questionnaires will be administered
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Adult individuals who voluntarily wish to participate in prevention events organized by participating centers Receives: Other: Prevention events organized by participating centers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of Risk of Heart Disease Scale
Individual perception of the likelihood of having heart disease
Measured: Screening
Systemic Coronary Risk Estimation version2
Individual real risk at 10 years, both for fatal CV events, and also for nonfatal CV events (myocardial infarction and stroke) in apparently healthy subjects
Measured: Screening
Patient Health Questionnaire-4
Screening for the uptake of psychological symptoms of anxiety or depression in the primary care setting
Measured: Screening
Duke-UNC Functional Social Support Questionnaire
Strength of affective support derived from people close to the enrolled subjects
Measured: Screening
Secondary outcomes (4)
Lipid panel
Lipid panel measurement
Measured: Screening
Glucose
Glucose measurement
Measured: Screening
Height
Height measurement
Measured: Screening
Weight
Weight measurement
Measured: Screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start29 Sep 2023
- Primary completion27 Oct 2023
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS San Raffaele, Centro Cardiologico Monzino, Istituto Auxologico Italiano, Istituti Ospedalieri Bergamaschi Srl
- Responsible party
- Sponsor
- Investigators
- Niccolò Simonelli, Study Nurse, Principal investigator, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190743
- Sponsor's protocol ID
- ASO.Card.23.01
- Acronym
- CV-RP
- Status last verified
- Dec 2023
- First submitted
- 27 Nov 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Simonelli N, Alberti M, D'andrea M, Trenta AM, Bagnato E, Faini A, Werba JP, Gianfranceschi E, Rosa D; CV-RP Study Group on behalf of the Italian Society of Cardiology and in collaboration with the Working Group of Nursing and Technical Care in Cardiology. Correctness of Cardiovascular Risk Perception in Primary Prevention Care: An Italian Cross-Sectional Multicenter Study. J Cardiovasc Nurs. 2026 Jul-Aug 01;41(4):298-304. doi: 10.1097/JCN.0000000000001240. Epub 2025 Jul 24.
PubMed 40702594
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of Cardiovascular Risk: Description of the Phenomenon in Primary Prevention
- ClinicalTrials.gov ID
- NCT06190743
- Acronym / sponsor ID
- CV-RP / ASO.Card.23.01
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Collaborators
- IRCCS San Raffaele, Centro Cardiologico Monzino, Istituto Auxologico Italiano, Istituti Ospedalieri Bergamaschi Srl
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- Sep 2024 (estimated)
- First posted
- 5 Jan 2024 (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.
The aim of the study is to describe the association between the perception of cardiovascular (CV) risk and the actual CV risk and, secondarily, to detect the actual CV risk to assess the prevalence of clinical risk factors, determined by means of appropriate instruments.
Detailed description
Cardiovascular (CV) disease is the major cause of premature death in adults that carries serious economic consequences.
Risk perception for CV disease has been reported as the subjective judgment of the likelihood of having a CV event. Risk perception is an important precursor to adopting a healthy lifestyle. However, both overestimation and underestimation of actual risk due mostly to poor health literacy are common.
For these reasons, CV prevention services of health care professionals (e.g., nurses, physicians) should, on the one hand, include screening for the presence of risk factors, and on the other hand, know the CV risk perceptions of those being cared for.
The aim of the study is to describe the association between the perception of cardiovascular (CV) risk, investigated by means of the Perception of Risk of Heart Disease Scale and a Likert-5 scale question, and the actual CV risk according to the SCORE2 and, secondarily, to detect the actual CV risk ascertained by the SCORE2 and to assess the prevalence of clinical risk factors (alterations in the lipid, glucose, or anthropometric profile) determined by means of appropriate instruments.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Prevention events organized by participating centersAdult individuals who voluntarily wish to participate in prevention events organized by participating centers |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Convenience sample of adult subjects who voluntarily wish to participate in prevention events and who will be asked for consent to participate
Key inclusion criteria (2 listed)
- an age between 18 and 69 years of age
- subscription to informed consent.
Key exclusion criteria (2 listed)
- patients with a positive history of hospitalization due to CV pathology at the time of enrollment;
- patients with ongoing relevant cognitive debilitation (Six Item Screener score < 4)
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 |
|---|---|---|
| Prevention events organized by participating centersCardiovascular disease primary prevention events organized by centers participating in the study where capillary sampling will be performed on subjects to quantify plasma levels of cardiovascular risk factors and validated questionnaires will be administered | Other | Study Group |
Primary outcome
Perception of Risk of Heart Disease Scale
Time frame: Screening
Individual perception of the likelihood of having heart disease
Systemic Coronary Risk Estimation version2
Time frame: Screening
Individual real risk at 10 years, both for fatal CV events, and also for nonfatal CV events (myocardial infarction and stroke) in apparently healthy subjects
Patient Health Questionnaire-4
Time frame: Screening
Screening for the uptake of psychological symptoms of anxiety or depression in the primary care setting
Duke-UNC Functional Social Support Questionnaire
Time frame: Screening
Strength of affective support derived from people close to the enrolled subjects
4 secondary outcomes
Lipid panel
Time frame: Screening
Glucose
Time frame: Screening
Height
Time frame: Screening
Weight
Time frame: Screening
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 40702594Simonelli N, Alberti M, D'andrea M, Trenta AM, Bagnato E, Faini A, Werba JP, Gianfranceschi E, Rosa D; CV-RP Study Group on behalf of the Italian Society of Cardiology and in collaboration with the Working Group of Nursing and Technical Care in Cardiology. Correctness of Cardiovascular Risk Perception in Primary Prevention Care: An Italian Cross-Sectional Multicenter Study. J Cardiovasc Nurs. 2026 Jul-Aug 01;41(4):298-304. doi: 10.1097/JCN.0000000000001240. Epub 2025 Jul 24.
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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.
Niccolò Simonelli, Study Nurse principal investigator
Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria at 1 site 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Perception of Risk of Heart Disease Scale (time frame: Screening). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06190743, which also lists 1 linked publication.
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 5 Jan 2024.