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

Coronary Artery Disease Clinical Trial

— EDCAD-PMS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04604353
• Other study ID #: 492/20
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2020
• Est. completion date: October 30, 2023

Study information

• Verified date: September 2023
• Source: Baker Heart and Diabetes Institute
• Contact: Carla Duarte, BS
• Phone: +61385321550
• Email: carla.duarte[@]baker.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 948
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• Polygenic Risk Score
Risk description to patient based on PRS
• Coronary Calcium Score
Risk description to patient based on CCS

Locations

Country	Name	City	State
Australia	Baker Heart and Diabetes Institute	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Baker Heart and Diabetes Institute

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Medication adherence in each group	Proportion of lipid-lowering tablets taken	12 months