None listed
Conditions
Brief summary
To assess whether incorporation of a polygenic risk score (PRS) into cardiovascular disease examinations (e.g., Heart Health Check), through the PPP-CAD clinical pathway, identifies subclinical CAD in participants considered to be at low or moderate 5-year absolute cardiovascular disease (CVD) risk (Absolute CVD Risk).
Interventions
ESCALATE study participants will undergo a cardiovascular disease (CVD) risk assessment with their general practitioner (GP), lasting approximately 1 hour and utilising the Partnership for Precision Prevention in Coronary Artery Disease (PPP-CAD) clinical pathway. Participants will complete a questionnaire at the time of enrolment, which is expected to take approximately 15 minutes.
A 5-year "absolute risk score" will be calculated for all participants, utilising the risk calculator provided b
ESCALATE study participants will undergo a cardiovascular disease (CVD) risk assessment with their general practitioner (GP), lasting approximately 1 hour and utilising the Partnership for Precision Prevention in Coronary Artery Disease (PPP-CAD) clinical pathway. Participants will complete a questionnaire at the time of enrolment, which is expected to take approximately 15 minutes. A 5-year "absolute risk score" will be calculated for all participants, utilising the risk calculator provided by the National Vascular Disease Prevention Alliance (www.CVDcheck.org.au). Participants considered High Risk of a CVD event within the next five years will not need to complete the rest of the clinical pathway; the GP will discuss his or her treatment recommendations with the participant. Participants who are considered to be low- or moderate-risk from this risk calculator will undergo a polygenic risk score (PRS) for CAD from Allelica. Participants with a PRS less than 80% will not need to complete the rest of the clinical pathway; the GP will discuss his or her treatment recommendations with the participant. Participants with a PRS of 80% or greater will be referred for a CT scan of the heart to calculate a coronary artery calcium score (CACS), which will involve attendance at a local imaging centre working with the study. The CT scan usually takes about 5 to 10 seconds and there are no injections required as part of this scan. The GP will use all the information from the heart disease assessment and CAC score (as available) to discuss his or her treatment recommendations with the participant. At the end of the PPP-CAD clinical pathway, participants will complete a questionnaire about their experience of a CVD examination utilising the PPP-CAD clinical pathway. Participants will complete a second questionnaire 6-months after their first visit with their GP. This questionnaire will ask participants about events occurring since the last visit, new diagnoses, and new medications he or she may be taking. Participants will return to their GP for a final visit 12-months after their first study visit. During this visit, the participant will complete a questionnaire, which should take approximately 15 minutes.
Sponsors
The University of Sydney
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
45 Years to 65 Years
Healthy volunteers
Yes
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.
Outcome results
None listed