Skip to main content
OpenTrials
Completed

NCT Number: NCT04604353

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baker Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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).

Treatment and study plan

Polygenic Risk Score

Diagnostic Test

Risk description to patient based on PRS

Coronary Calcium Score

Diagnostic Test

Risk description to patient based on CCS

Primary outcomes

  1. Change in cardiovascular risk in each group

    Time frame: 12 months

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

Secondary outcomes

  1. Medication adherence in each group

    Time frame: 12 months

    Proportion of lipid-lowering tablets taken

Sponsors and collaborators

Lead sponsor

Baker Heart and Diabetes Institute

Other

Registry information

Official study title

Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk Scoring in at Risk Patients: Comparison With Coronary Computed Tomography

Acronym: EDCAD-PMS

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 27, 2020
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.