- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04604353
Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk Scoring (EDCAD-PMS)
September 26, 2023 updated by: Baker Heart and Diabetes Institute
Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk Scoring in at Risk Patients: Comparison With Coronary Computed Tomography
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
948
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carla Duarte, BS
- Phone Number: +61385321550
- Email: carla.duarte@baker.edu.au
Study Contact Backup
- Name: Thomas H Marwick, MD, PhD, MPH
- Phone Number: +61385321550
- Email: tom.marwick@baker.edu.au
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3004
- Recruiting
- Baker Heart and Diabetes Institute
-
Contact:
- Thomas Marwick
- Phone Number: +61385321550
- Email: tom.marwick@baker.edu.au
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PRS score group
Risk information provided on the basis of Polygenic Risk Score combined with the Pooled Cohort Equation
|
Risk description to patient based on PRS
|
Active Comparator: CCS score group
Risk information provided on the basis of Coronary Calcium Score combined with the Pooled Cohort Equation
|
Risk description to patient based on CCS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication adherence in each group
Time Frame: 12 months
|
Proportion of lipid-lowering tablets taken
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thomas H Marwick, MD, PhD, MPH, Baker Heart and Diabetes Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 7, 2020
Primary Completion (Estimated)
October 30, 2023
Study Completion (Estimated)
October 30, 2023
Study Registration Dates
First Submitted
October 19, 2020
First Submitted That Met QC Criteria
October 24, 2020
First Posted (Actual)
October 27, 2020
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 26, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 492/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data sharing based available on application to the study PI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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