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

NCT04604353 | Completed

• 1 other identifier: 492/20
• Study Type: interventional
• Target: 1,059
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Change in cardiovascular risk in each group

  Change in cardiovascular risk (expressed as pooled cohort equation 10-year risk percentage) from baseline to follow-up

  12 months

Secondary Outcomes (1)

• Medication adherence in each group

  12 months

Study Arms (2)

PRS score group

EXPERIMENTAL

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

Diagnostic Test: Polygenic Risk Score

CCS score group

ACTIVE COMPARATOR

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

Diagnostic Test: Coronary Calcium Score

Interventions

Polygenic Risk Score DIAGNOSTIC_TEST

Risk description to patient based on PRS

PRS score group

Coronary Calcium Score DIAGNOSTIC_TEST

Risk description to patient based on CCS

CCS score group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Symptomatic coronary, cerebrovascular, or peripheral vascular disease
• Intolerance of statins or currently on statins for any length of time
• Pre-existing muscle disease (eg polymyositis, fibromyalgia) - this may be confused with myalgia from statins
• 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)
• Atrial fibrillation (interferes with CTCA)
• 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
• Inability to provide informed consent
• Major systemic illness eg. malignancy; rheumatoid arthritis
• Women of child bearing potential (due to performance of CT)
• Poorly controlled hypertension: SBP\> 200 and or DBP \> 100
• Severe psychiatric disorder (eg bipolar depression; psychosis)
• Patients eligible for treatment based on current Australian guidelines (5 year risk \>15%)
• Patients eligible for treatment based on current PBS thresholds TC \>7.5 mmol/l and other criteria (see below).

Sponsors & Collaborators

• Baker Heart and Diabetes Institute: lead

Study Sites (1)

Baker Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Thomas H Marwick, MD, PhD, MPH

  Baker Heart and Diabetes Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will receive baseline and 12 month risk based on Pooled Cohort Equation and photographic evidence of treatment adherence
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization to provision of PRS-based or CCS-based risk

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 27, 2020
• Study Start: December 7, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: August 22, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)