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Recruiting NCT07521436

Awareness of Risk Factors and Perception of Cardiovascular Risk in Secondary Prevention Among Women and Men

Observational Cardiovascular Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Cardiovascular Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other No intervention
    There is not an intervention

Primary outcome measures

  • Awareness of cardiovascular risk factors [Time frame: At enrollment]
  • Self-reported risk perception of CVD [Time frame: At enrollment]
  • Self-reported comparative risk perception [Time frame: At enrollment]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Istituti Clinici Scientifici IRCCS Maugeri — Milan

Identifiers

NCT: NCT07521436 · 2777/CEL CE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗