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

  • STATUS
    Recruiting
  • End date
    Oct 30, 2023
  • participants needed
    948
  • sponsor
    Baker Heart and Diabetes Institute
Updated on 1 February 2021

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.

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.

Details
Condition Coronary Artery Disease, Coronary heart disease, Cardiac Ischemia, Myocardial Ischemia
Treatment Polygenic Risk Score, Coronary Calcium Score
Clinical Study IdentifierNCT04604353
SponsorBaker Heart and Diabetes Institute
Last Modified on1 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 40 yrs and 70 yrs?
Gender: Male or Female
Do you have any of these conditions: Myocardial Ischemia or Coronary heart disease or Cardiac Ischemia or Coronary Artery Disease?
Asymptomatic subjects age 40-70y
Statin nave
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)
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