Awareness of Risk Factors and Perception of Cardiovascular Risk in Secondary Prevention Among Women and Men (CORPS-CV)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • Istituti Clinici Scientifici IRCCS Maugeri
    • Contact: Alessandra Gorini; Phone Number: 00390250725263; Email: alessandra.gorini@icsmaugeri.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Awareness of cardiovascular risk factors	Mean cardiovascular risk factor knowledge score, defined as the total number of correctly identified cardiovascular risk factors.	At enrollment
Self-reported risk perception of CVD	Defined as percentage of categorical variables (low, medium, high)	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).	At enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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).	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.	At enrollment

Collaborators and Investigators

• Sponsor: Istituti Clinici Scientifici Maugeri SpA
• Collaborators: A.R.C.A Associazioni Regionali Cardiologi Ambulatoriali

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2026
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): January 10, 2027

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 2777/CEL CE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No