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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituti Clinici Scientifici Maugeri SpA

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female participants aged ≥ 18 years at the time of signing informed consent.

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);

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • No intervention

    Other intervention

    There is not an intervention

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Awareness of cardiovascular risk factors

Mean cardiovascular risk factor knowledge score, defined as the total number of correctly identified cardiovascular risk factors.

Time frame
At enrollment
2

Self-reported risk perception of CVD

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

Time frame
At enrollment
3

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).

Time frame
At enrollment

Secondary outcomes

1

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)

Time frame
At enrollments
2

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).

Time frame
At enrollment
3

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.

Time frame
At enrollment

Other outcomes

Sponsors and contacts

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