Impact of incorporating a polygenic risk score into cardiovascular disease examinations on the identification of subclinical coronary artery disease (CAD)

Not Applicable

Recruiting

• Conditions: Cardiovascular disease; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12622000436774
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-18
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Males aged 45 to 60 years old
- Females aged 50 to 65 years old
- Eligible for a Medicare rebated cardiovascular disease consultation with a GP, including Heart Health Check MBS Item Numbers 177 or 699
- Willingness to undergo the PRS and/or CACS interventions as indicated per the PPP-CAD clinical pathway
- At least one (1) prior clinical visit to the GP
- Willing and able to provide informed consent by self

Exclusion Criteria

- Conditions placing the individual at clinically determined high risk of CVD, not requiring calculation of Absolute CVD Risk:
- Diabetes and age greater than 60 years
-Diabetes with microalbuminuria (greater than 20 mcg/min or UACR greater than 2.5 mg/mmol for males, greater than 3.5 mg/mmol for females)
- Moderate or severe chronic kidney disease (CKD) (persistent proteinuria or eGFR less than 45mL/min/1.73m2)
- Previous diagnosis of familial hypercholesterolaemia
- Systolic blood pressure (SBP) greater than or equal to 180mmHg or diastolic blood pressure (DBP) greater than or equal to 110mmHg
- Serum total cholesterol greater than 7.5mmol/L
- Symptomatic or previously documented CAD
- Previous CVD event, including angina, myocardial infarction (MI), percutaneous coronary intervention, coronary artery bypass grafting, ischaemic stroke, transient ischaemic attack, heart failure, or peripheral arterial disease.
- Prior mediastinal radiation exposure or therapy
- Prior medical diagnosis of rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE)
- Patients highly dependent on medical care and unable to provide informed consent
- Unable or unwilling to participate in 12-month follow-up
- People with cognitive impairment, intellectual disability, or mental illness that prevent them from providing informed consent for themselves.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants considered to be low or moderate calculated Absolute CVD Risk, and in Top Quintile PRS Risk, with subclinical CAD—defined as a non-zero CACS—identified utilising the PPP-CAD clinical pathway. [ From the time of enrolment to the end of the PPP-CAD clinical pathway]