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Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk Scoring (EDCAD-PMS)

Primary Purpose

Coronary Artery Disease

Status

Recruiting

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

Polygenic Risk Score

Coronary Calcium Score

About this trial

This is an interventional prevention trial for Coronary Artery Disease

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Baker Heart and Diabetes InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRS score group

CCS score group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Medication adherence in each group

Proportion of lipid-lowering tablets taken

Full Information

NCT ID

NCT04604353

First Posted

October 19, 2020

Last Updated

September 26, 2023

Sponsor

Baker Heart and Diabetes Institute

1. Study Identification

Unique Protocol Identification Number

NCT04604353

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 7, 2020 (Actual)

Primary Completion Date

October 30, 2023 (Anticipated)

Study Completion Date

October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Baker Heart and Diabetes Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Outcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

948 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PRS score group

Arm Type

Experimental

Arm Description

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

Arm Title

CCS score group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Polygenic Risk Score

Intervention Description

Risk description to patient based on PRS

Intervention Type

Diagnostic Test

Intervention Name(s)

Coronary Calcium Score

Intervention Description

Risk description to patient based on CCS

Primary Outcome Measure Information:

Title

Change in cardiovascular risk in each group

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Medication adherence in each group

Description

Proportion of lipid-lowering tablets taken

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Carla Duarte, BS

Phone

+61385321550

carla.duarte@baker.edu.au

First Name & Middle Initial & Last Name or Official Title & Degree

Thomas H Marwick, MD, PhD, MPH

Phone

+61385321550

tom.marwick@baker.edu.au

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas H Marwick, MD, PhD, MPH

Organizational Affiliation

Baker Heart and Diabetes Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Baker Heart and Diabetes Institute

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas Marwick

Phone

+61385321550

tom.marwick@baker.edu.au

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data sharing based available on application to the study PI

Learn more about this trial

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

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