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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1059 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-07

Study Completion Date

2023-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization to provision of PRS-based or CCS-based risk

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Outcomes assessor will receive baseline and 12 month risk based on Pooled Cohort Equation and photographic evidence of treatment adherence

Study Groups

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PRS score group

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

Group Type EXPERIMENTAL

Polygenic Risk Score

Intervention Type DIAGNOSTIC_TEST

Risk description to patient based on PRS

CCS score group

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

Group Type ACTIVE_COMPARATOR

Coronary Calcium Score

Intervention Type DIAGNOSTIC_TEST

Risk description to patient based on CCS

Interventions

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Polygenic Risk Score

Risk description to patient based on PRS

Intervention Type DIAGNOSTIC_TEST

Coronary Calcium Score

Risk description to patient based on CCS

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes