Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk Scoring (EDCAD-PMS)

Baker Heart and Diabetes Institute

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Diagnostic Test: Coronary Calcium Score; Diagnostic Test: Polygenic Risk Score

Study type: Interventional

Funder types: Other

Identifiers

NCT04604353

492/20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,059 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,059 participants in 2 patient groups

PRS score group

Experimental group

Description:

Risk information provided on the basis of Polygenic Risk Score combined with the Pooled Cohort Equation

Treatment:

Diagnostic Test: Polygenic Risk Score

CCS score group

Active Comparator group

Description:

Risk information provided on the basis of Coronary Calcium Score combined with the Pooled Cohort Equation

Treatment:

Diagnostic Test: Coronary Calcium Score