NCT05693857

Brief Summary

Cardiovascular prevention guidelines use estimated 10-year atherosclerotic cardiovascular disease (ASCVD) risk to guide treatment decisions and engage patients in shared decision-making. Research has focused on refining the accuracy of these CV risk calculators for different populations, relatively little has been done to understand how patients perceive their own ASCVD risk. Accurate perception of a patient's risk by both the patient and the doctors is important because this is an important determinant of health-related behaviour. Patients often show optimistic bias when considering their own CV risk and consistently underestimate it. We aim to determine patient perceived versus actual risk of ASCVD in a Chinese population. We aim to better understand the degree to which patients underestimate or overestimate their ASCVD risk and whether patients are better or worse at estimating their ASCVD risk relative to their peers of the same age and sex. Finally, we aim to evaluate patients willingness to follow guideline recommended CV prevention and specifically lipid-lowering therapy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
28mo left

Started Jun 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress56%
Jun 2023Aug 2028

First Submitted

Initial submission to the registry

January 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

June 11, 2023

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2028

Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

4.7 years

First QC Date

January 12, 2023

Last Update Submit

February 15, 2024

Conditions

Keywords

Cardiovascular Diseaselipid-lowering therapy

Outcome Measures

Primary Outcomes (1)

  • Evaluate correlation between patients' own estimates of their 10-year risk of heart disease or stroke with actual pooled-cohort-equation calculated risk estimates (using a validated CV risk calculation app).

    12-months

Secondary Outcomes (6)

  • Evaluate correlation between perceived and calculated 10-year CV risk in sub-groups based on age, sex, education level, known CV risks (e.g. smoking, diabetes, hyperlipidemia and hypertension

    12-months

  • Evaluate patients' own estimates of 10-year CV risk relative to their peers using age- and sex-specific population risk percentiles.

    12-months

  • Evaluate patients' willingness to follow recommendations for CV prevention based on their calculated 10-year CV risk profile (e.g. dietary, exercise, smoking and CV risk factor control)

    12-months

  • Evaluate whether perceived or actual CVD risk is associated with current statin use or willingness to take statin.

    12-months

  • Reasons for unwillingness to follow recommendations for CV preventions

    12-months

  • +1 more secondary outcomes

Interventions

Cardiovascular prevention guidelines use estimated 10-year atherosclerotic cardiovascular disease (ASCVD) risk to guide treatment decisions and engage patients in shared decision-making

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study will recruit up to 1500 patients from PWH outpatient clinics (stratified by age groups 40-59, 60-79 and ≥80 years of age)

You may qualify if:

  • Aged 40 years and above
  • Consent to complete questionnaire
  • Lipid profile within 12 months

You may not qualify if:

  • Known ASCVD defined as history of coronary heart disease (i.e. obstructive coronary disease, prior myocardial infarction, or prior coronary revascularization); cerebrovascular disease (i.e. stroke or transient ischemic attack); and peripheral arterial disease (i.e. obstructive peripheral disease, prior vascular amputation or prior revascularization)
  • Other chronic illness with life-expectancy \<12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Shatin, 999077, Hong Kong

RECRUITING

Related Publications (5)

  • Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Angelantonio ED, Franco OH, Halvorsen S, Richard Hobbs FD, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice: Developed by the Task Force for cardiovascular disease prevention in clinical practice with representatives of the European Society of Cardiology and 12 medical societies With the special contribution of the European Association of Preventive Cardiology (EAPC). Rev Esp Cardiol (Engl Ed). 2022 May;75(5):429. doi: 10.1016/j.rec.2022.04.003. No abstract available. English, Spanish.

  • Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Sep 10;140(11):e563-e595. doi: 10.1161/CIR.0000000000000677. Epub 2019 Mar 17.

  • Lloyd-Jones DM, Braun LT, Ndumele CE, Smith SC Jr, Sperling LS, Virani SS, Blumenthal RS. Use of Risk Assessment Tools to Guide Decision-Making in the Primary Prevention of Atherosclerotic Cardiovascular Disease: A Special Report From the American Heart Association and American College of Cardiology. J Am Coll Cardiol. 2019 Jun 25;73(24):3153-3167. doi: 10.1016/j.jacc.2018.11.005. Epub 2018 Nov 10.

  • Webster R, Heeley E. Perceptions of risk: understanding cardiovascular disease. Risk Manag Healthc Policy. 2010;3:49-60. doi: 10.2147/RMHP.S8288. Epub 2010 Sep 6.

  • Thakkar J, Heeley EL, Chalmers J, Chow CK. Inaccurate risk perceptions contribute to treatment gaps in secondary prevention of cardiovascular disease. Intern Med J. 2016 Mar;46(3):339-46. doi: 10.1111/imj.12982.

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 23, 2023

Study Start

June 11, 2023

Primary Completion (Estimated)

February 11, 2028

Study Completion (Estimated)

August 11, 2028

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations