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NCT Number: NCT07521436

Awareness of Risk Factors and Perception of Cardiovascular Risk in Secondary Prevention Among 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituti Clinici Scientifici IRCCS Maugeri

Milan, Italy

Location status: Recruiting

Location contact

Alessandra Gorini

CONTACT

[email protected]

00390250725263

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

No intervention

Other

There is not an intervention

Primary outcomes

  1. 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.

  2. Self-reported risk perception of CVD

    Time frame: At enrollment

    Defined as percentage of categorical variables (low, medium, high)

  3. 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).

Secondary outcomes

  1. Differences among females and males in self-assessed risk perception

    Time frame: At enrollments

    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)

  2. Differences among females and males in self-reported comparative risk perception

    Time frame: At enrollment

    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).

  3. Comparisons between responders in primary and secondary prevention

    Time frame: At enrollment

    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.

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Registry information

Official study title

Awareness of Risk Factors and Perception of Cardiovascular Risk in Secondary Prevention: A Comparison Between Women and Men

Acronym: CORPS-CV

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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