Cardiovascular DiseaseCORPS-CVNCT07521436
Awareness of Risk Factors and Perception of Cardiovascular Risk in Secondary Prevention Among Women and Men
An observational study of Cardiovascular Disease, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
The present research project aims to assess, through a survey, awareness of general and sex/gender-specific cardiovascular risk factors, as well as the perception of the risk of developing further cardiovascular diseases, among patients in secondary prevention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 10 Apr 2026to 10 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study involves the recruitment of adult patients attending the cardiology outpatient clinics of the participating centers who meet the inclusion criteria. Participation will be voluntary and contingent upon the signing of informed consent. Patients will complete the questionnaire in a self-administered format, either on paper or digitally via their own device (smartphone or tablet), according to their preference.
Who may be able to join
- Male or female participants aged ≥ 18 years at the time of signing informed consent.
- Individuals with atherosclerotic cardiovascular disease (ASCVD), defined as at least one of the following:
- Ischemic heart disease (e.g., documented myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, or ≥50% coronary stenosis in at least two coronary territories);
- Cerebrovascular disease (e.g., documented ischemic stroke; transient ischemic attack, primary intracerebral hemorrhage, and subarachnoid hemorrhage are not qualifying conditions; carotid stenting or endarterectomy);
- Peripheral arterial disease (e.g., peripheral arterial intervention, stent placement, surgical revascularization, lower limb amputation due to obstructive disease, or intermittent claudication with ABI <0.90 in the past 12 months);
- Atherosclerotic aortic disease (e.g., abdominal or descending thoracic aortic aneurysm).
- Signed informed consent.
Who cannot join
- Inability or difficulty in completing the questionnaires in Italian and/or functional illiteracy.
- History of or current severe psychiatric disorder that could compromise the reliability of questionnaire responses.
- Refusal or withdrawal of informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituti Clinici Scientifici IRCCS Maugeri
Milan
Alessandra Gorini, 00390250725263, alessandra.gorini@icsmaugeri.it
About this study
Official title: Awareness of Risk Factors and Perception of Cardiovascular Risk in Secondary Prevention: A Comparison Between Women and Men
The present research project aims to assess, through a survey, awareness of general and sex/gender-specific cardiovascular risk factors, as well as the perception of the risk of developing further cardiovascular diseases, among patients in secondary prevention.
Read the detailed description
Despite the well-established impact of various factors, some of which are specific to biological sex and/or gender, on the risk of developing cardiovascular disease, awareness of these factors and perception of cardiovascular risk remain insufficient in the general population. This is even more evident among women, who demonstrate limited knowledge of risk factors (including sex-specific factors such as early menopause, gestational diabetes, polycystic ovary syndrome, and systemic inflammatory and autoimmune disorders) and a markedly underestimated perception of cardiovascular risk, as shown in several studies conducted in primary prevention samples.
To date, however, there are no available data on awareness and risk perception, among either men or women in secondary prevention, investigating the potential influence that a prior cardiovascular event may exert on perceived risk of recurrence and on knowledge of risk factors, including those specific to sex and gender.
Based on assumptions derived from various Health Behavior Theories, the cognitive and emotional changes that occur following an acute event should enhance both knowledge and risk perception and, consequently, influence health-related behaviors and decision-making. However, healthcare professionals do not always observe such changes after an acute event. This shift would be particularly critical among women who, compared to men in secondary prevention, exhibit lower rates of treatment adherence and reduced participation in follow-up programs, behaviors that increase their likelihood of recurrence and contribute to poorer long-term outcomes.
- Conditions
- Cardiovascular Disease
- Being tested
- No intervention
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is not an intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Awareness of cardiovascular risk factors
Mean cardiovascular risk factor knowledge score, defined as the total number of correctly identified cardiovascular risk factors.
Measured: At enrollment
Self-reported risk perception of CVD
Defined as percentage of categorical variables (low, medium, high)
Measured: At enrollment
Self-reported comparative risk perception
Individual subjective evaluation of their own risk relative to a reference group (individuals of the same age and of the same or opposite biological sex), measured as a categorical variable (lower/equal/higher/unknown) (Self-reported comparative risk perception).
Measured: At enrollment
Secondary outcomes (3)
Differences among females and males in self-assessed risk perception
Difference in mean cardiovascular risk factor knowledge score between females and males .
Distribution of self-perceived cardiovascular risk level (low/medium/high) according to biological sex. (self-assessed risk perception)
Measured: At enrollments
Differences among females and males in self-reported comparative risk perception
Differences among females and males in Individual subjective evaluation of their own risk relative to a reference group (individuals of the same age and of the same or opposite biological sex), measured as a categorical variable (lower/equal/higher/unknown) (Self-reported comparative risk perception).
Measured: At enrollment
Comparisons between responders in primary and secondary prevention
Differences in data on awareness of cardiovascular risk factors and perception of cardiovascular risk among women with findings from previous studies conducted in primary prevention.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start10 Apr 2026
- Primary completion10 Jan 2027 (estimated)
- Study completion10 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521436
- Sponsor's protocol ID
- 2777/CEL CE
- Acronym
- CORPS-CV
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awareness of Risk Factors and Perception of Cardiovascular Risk in Secondary Prevention: A Comparison Between Women and Men
- ClinicalTrials.gov ID
- NCT07521436
- Acronym / sponsor ID
- CORPS-CV / 2777/CEL CE
- Conditions
- Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 10 Jan 2027 (estimated)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 9 Apr 2026 (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 present research project aims to assess, through a survey, awareness of general and sex/gender-specific cardiovascular risk factors, as well as the perception of the risk of developing further cardiovascular diseases, among patients in secondary prevention.
Detailed description
Despite the well-established impact of various factors, some of which are specific to biological sex and/or gender, on the risk of developing cardiovascular disease, awareness of these factors and perception of cardiovascular risk remain insufficient in the general population. This is even more evident among women, who demonstrate limited knowledge of risk factors (including sex-specific factors such as early menopause, gestational diabetes, polycystic ovary syndrome, and systemic inflammatory and autoimmune disorders) and a markedly underestimated perception of cardiovascular risk, as shown in several studies conducted in primary prevention samples.
To date, however, there are no available data on awareness and risk perception, among either men or women in secondary prevention, investigating the potential influence that a prior cardiovascular event may exert on perceived risk of recurrence and on knowledge of risk factors, including those specific to sex and gender.
Based on assumptions derived from various Health Behavior Theories, the cognitive and emotional changes that occur following an acute event should enhance both knowledge and risk perception and, consequently, influence health-related behaviors and decision-making. However, healthcare professionals do not always observe such changes after an acute event. This shift would be particularly critical among women who, compared to men in secondary prevention, exhibit lower rates of treatment adherence and reduced participation in follow-up programs, behaviors that increase their likelihood of recurrence and contribute to poorer long-term outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study involves the recruitment of adult patients attending the cardiology outpatient clinics of the participating centers who meet the inclusion criteria. Participation will be voluntary and contingent upon the signing of informed consent. Patients will complete the questionnaire in a self-administered format, either on paper or digitally via their own device (smartphone or tablet), according to their preference.
Key inclusion criteria (7 listed)
- Male or female participants aged ≥ 18 years at the time of signing informed consent.
- Individuals with atherosclerotic cardiovascular disease (ASCVD), defined as at least one of the following:
- Ischemic heart disease (e.g., documented myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, or ≥50% coronary stenosis in at least two coronary territories);
- Cerebrovascular disease (e.g., documented ischemic stroke; transient ischemic attack, primary intracerebral hemorrhage, and subarachnoid hemorrhage are not qualifying conditions; carotid stenting or endarterectomy);
- Peripheral arterial disease (e.g., peripheral arterial intervention, stent placement, surgical revascularization, lower limb amputation due to obstructive disease, or intermittent claudication with ABI <0.90 in the past 12 months);
Key exclusion criteria (3 listed)
- Inability or difficulty in completing the questionnaires in Italian and/or functional illiteracy.
- History of or current severe psychiatric disorder that could compromise the reliability of questionnaire responses.
- Refusal or withdrawal of informed consent.
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 |
|---|---|---|
| No interventionThere is not an intervention | Other | – |
Primary outcome
Awareness of cardiovascular risk factors
Time frame: At enrollment
Mean cardiovascular risk factor knowledge score, defined as the total number of correctly identified cardiovascular risk factors.
Self-reported risk perception of CVD
Time frame: At enrollment
Defined as percentage of categorical variables (low, medium, high)
Self-reported comparative risk perception
Time frame: At enrollment
Individual subjective evaluation of their own risk relative to a reference group (individuals of the same age and of the same or opposite biological sex), measured as a categorical variable (lower/equal/higher/unknown) (Self-reported comparative risk perception).
3 secondary outcomes
Differences among females and males in self-assessed risk perception
Time frame: At enrollments
Differences among females and males in self-reported comparative risk perception
Time frame: At enrollment
Comparisons between responders in primary and secondary prevention
Time frame: At enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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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.
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 Disease, run by Istituti Clinici Scientifici Maugeri SpA 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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Awareness of cardiovascular risk factors (time frame: At enrollment). The study lists 3 primary outcomes in all. 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 29 Apr 2026.