Perception of Cardiovascular Risk

Cardiovascular Diseases Clinical Trial

— CV-RP  

Official title:

Perception of Cardiovascular Risk: Description of the Phenomenon in Primary Prevention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06190743
• Other study ID #: ASO.Card.23.01
• Status: Active, not recruiting
• Start date: September 29, 2023
• Est. completion date: September 2024

Study information

• Verified date: December 2023
• Source: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is to describe the association between the perception of cardiovascular (CV) risk and the actual CV risk and, secondarily, to detect the actual CV risk to assess the prevalence of clinical risk factors, determined by means of appropriate instruments.

Description:

Cardiovascular (CV) disease is the major cause of premature death in adults that carries serious economic consequences. Risk perception for CV disease has been reported as the subjective judgment of the likelihood of having a CV event. Risk perception is an important precursor to adopting a healthy lifestyle. However, both overestimation and underestimation of actual risk due mostly to poor health literacy are common. For these reasons, CV prevention services of health care professionals (e.g., nurses, physicians) should, on the one hand, include screening for the presence of risk factors, and on the other hand, know the CV risk perceptions of those being cared for. The aim of the study is to describe the association between the perception of cardiovascular (CV) risk, investigated by means of the Perception of Risk of Heart Disease Scale and a Likert-5 scale question, and the actual CV risk according to the SCORE2 and, secondarily, to detect the actual CV risk ascertained by the SCORE2 and to assess the prevalence of clinical risk factors (alterations in the lipid, glucose, or anthropometric profile) determined by means of appropriate instruments.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 271
• Est. completion date: September 2024
• Est. primary completion date: October 27, 2023
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• an age between 18 and 69 years of age
• subscription to informed consent.

Exclusion Criteria:

• patients with a positive history of hospitalization due to CV pathology at the time of enrollment;
• patients with ongoing relevant cognitive debilitation (Six Item Screener score < 4)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases

Intervention

Other:
• Prevention events organized by participating centers
Cardiovascular disease primary prevention events organized by centers participating in the study where capillary sampling will be performed on subjects to quantify plasma levels of cardiovascular risk factors and validated questionnaires will be administered

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo	Alessandria	Piedmont

Sponsors (5)

Lead Sponsor	Collaborator
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria	Centro Cardiologico Monzino, IRCCS San Raffaele, Istituti Ospedalieri Bergamaschi Srl, Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perception of Risk of Heart Disease Scale	Individual perception of the likelihood of having heart disease	Screening
Primary	Systemic Coronary Risk Estimation version2	Individual real risk at 10 years, both for fatal CV events, and also for nonfatal CV events (myocardial infarction and stroke) in apparently healthy subjects	Screening
Primary	Patient Health Questionnaire-4	Screening for the uptake of psychological symptoms of anxiety or depression in the primary care setting	Screening
Primary	Duke-UNC Functional Social Support Questionnaire	Strength of affective support derived from people close to the enrolled subjects	Screening
Secondary	Lipid panel	Lipid panel measurement	Screening
Secondary	Glucose	Glucose measurement	Screening
Secondary	Height	Height measurement	Screening
Secondary	Weight	Weight measurement	Screening