Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
271

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 29, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 27, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

January 5, 2024

Status Verified

December 1, 2023

Enrollment Period

28 days

First QC Date

November 27, 2023

Last Update Submit

December 19, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Perception of Risk of Heart Disease Scale

    Individual perception of the likelihood of having heart disease

    Screening

  • 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

  • Patient Health Questionnaire-4

    Screening for the uptake of psychological symptoms of anxiety or depression in the primary care setting

    Screening

  • Duke-UNC Functional Social Support Questionnaire

    Strength of affective support derived from people close to the enrolled subjects

    Screening

Secondary Outcomes (4)

  • Lipid panel

    Screening

  • Glucose

    Screening

  • Height

    Screening

  • Weight

    Screening

Study Arms (1)

Study Group

Adult individuals who voluntarily wish to participate in prevention events organized by participating centers

Other: Prevention events organized by participating centers

Interventions

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

Study Group

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Convenience sample of adult subjects who voluntarily wish to participate in prevention events and who will be asked for consent to participate

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

Alessandria, Piedmont, 15121, Italy

Location

Related Publications (1)

  • Simonelli N, Alberti M, D'andrea M, Trenta AM, Bagnato E, Faini A, Werba JP, Gianfranceschi E, Rosa D; CV-RP Study Group* on behalf of the Italian Society of Cardiology and in collaboration with the Working Group of Nursing and Technical Care in Cardiology. Correctness of Cardiovascular Risk Perception in Primary Prevention Care: A Multicenter Cross-sectional Italian Study. J Cardiovasc Nurs. 2025 Jul 24. doi: 10.1097/JCN.0000000000001240. Online ahead of print.

MeSH Terms

Conditions

Cardiovascular DiseasesHeart Diseases

Study Officials

  • Niccolò Simonelli, Study Nurse

    Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2023

First Posted

January 5, 2024

Study Start

September 29, 2023

Primary Completion

October 27, 2023

Study Completion

September 1, 2024

Last Updated

January 5, 2024

Record last verified: 2023-12

Locations