Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk Scoring

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: Polygenic Risk Score; Diagnostic Test: Coronary Calcium Score

• Registration Number: NCT04604353
• Lead Sponsor: Baker Heart and Diabetes Institute

Brief Summary

The overall goal of this study is to develop a combined polygenic risk score (PRS) and metabolic risk score (MRS) and determine its impact on selecting community members for CCS. The trial component of this study will compare the use of these scores to motivate people to adhere to therapy, an ongoing challenge for clinicians, by providing feedback in a meaningful form to both the clinicians and the patients.

Detailed Description

Patients undergoing a polygenic risk score (PRS), metabolic risk score (MRS) and coronary calcium score (CCS) will be randomized to receive PRS and CCS information and followed for the reduction of risk over 12 months. This information will provide information about how to motivate people to adhere to therapy, by providing feedback in a meaningful form to both the clinicians and the patients.

Study Timeline

• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-10-24
• Study First Posted: 2020-10-27
• Study Start: 2020-12-07
• Status Verified: 2023-09
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1059

Inclusion Criteria

1. Asymptomatic subjects age 40-70y
2. Statin naïve
3. TC ≤ 6.5 mmol/L and LDLC <5 mmol/L, and
4. 5 year Australian risk ≥2%.

Exclusion Criteria

1. Symptomatic coronary, cerebrovascular, or peripheral vascular disease
2. Intolerance of statins or currently on statins for any length of time
3. Pre-existing muscle disease (eg polymyositis, fibromyalgia) - this may be confused with myalgia from statins
4. Patients on drugs that increase the risk of myopathy/rhabdomyolysis such as cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, and HIV/hepatitis C protease inhibitors)
5. Atrial fibrillation (interferes with CTCA)
6. Chronic kidney disease on haemodialysis (because of vascular calcification) or GFR <50ml/min per 1.73m2 using the Modification of Diet in Renal Disease (MDRD) formula
7. Inability to provide informed consent
8. Major systemic illness eg. malignancy; rheumatoid arthritis
9. Women of child bearing potential (due to performance of CT)
10. Poorly controlled hypertension: SBP> 200 and or DBP > 100
11. Severe psychiatric disorder (eg bipolar depression; psychosis)
12. Patients eligible for treatment based on current Australian guidelines (5 year risk >15%)
13. Patients eligible for treatment based on current PBS thresholds TC >7.5 mmol/l and other criteria (see below).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRS score group	Polygenic Risk Score	Risk information provided on the basis of Polygenic Risk Score combined with the Pooled Cohort Equation
CCS score group	Coronary Calcium Score	Risk information provided on the basis of Coronary Calcium Score combined with the Pooled Cohort Equation

Primary Outcome Measures

Name	Time	Method
Change in cardiovascular risk in each group	12 months	Change in cardiovascular risk (expressed as pooled cohort equation 10-year risk percentage) from baseline to follow-up

Secondary Outcome Measures

Name	Time	Method
Medication adherence in each group	12 months	Proportion of lipid-lowering tablets taken

Trial Locations

Locations (1)

Baker Heart and Diabetes Institute; 🇦🇺 Melbourne, Victoria, Australia