Clinical trial NCT04604353: Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk Scoring
Official title: Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk Scoring in at Risk Patients: Comparison With Coronary Computed Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Baker Heart and Diabetes Institute
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 1059
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to provision of PRS-based or CCS-based risk
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in cardiovascular risk in each group
timeFrame: 12 months
Secondary outcomes:
measure: Medication adherence in each group
timeFrame: 12 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Baker Heart and Diabetes Institute
state: Victoria
Study officials:
affiliation: Baker Heart and Diabetes Institute
name: Thomas H Marwick, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: