Coronary Artery DiseaseEDCAD-PMSNCT04604353
Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk Scoring
A study testing Polygenic Risk Score and Coronary Calcium Score in people with Coronary Artery Disease, run by Baker Heart and Diabetes Institute at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Polygenic Risk Score and Coronary Calcium Score
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,059 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Dec 2020to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asymptomatic subjects age 40-70y
- Statin naïve
- TC ≤ 6.5 mmol/L and LDLC <5 mmol/L, and
- 5 year Australian risk ≥2%.
Who cannot join
- 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
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- 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).
Trial locations and contacts
1 site in 1 country.
Australia1 site
Baker Heart and Diabetes Institute
Melbourne, Victoria, 3004
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Polygenic Risk Score, Coronary Calcium Score
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polygenic Risk ScoreDiagnostic test
Risk description to patient based on PRS
Coronary Calcium ScoreDiagnostic test
Risk description to patient based on CCS
| Study group | Role | What they receive |
|---|---|---|
| PRS score group | Experimental | Risk information provided on the basis of Polygenic Risk Score combined with the Pooled Cohort Equation Receives: Diagnostic Test: Polygenic Risk Score |
| CCS score group | Active comparator | Risk information provided on the basis of Coronary Calcium Score combined with the Pooled Cohort Equation Receives: Diagnostic Test: Coronary Calcium Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
Medication adherence in each group
Proportion of lipid-lowering tablets taken
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start7 Dec 2020
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to provision of PRS-based or CCS-based risk
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,059 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baker Heart and Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas H Marwick, MD, PhD, MPH, Principal investigator, Baker Heart and Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604353
- Sponsor's protocol ID
- 492/20
- Acronym
- EDCAD-PMS
- Status last verified
- Sep 2023
- First submitted
- 19 Oct 2020
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing based available on application to the study PI
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk Scoring in at Risk Patients: Comparison With Coronary Computed Tomography
- ClinicalTrials.gov ID
- NCT04604353
- Acronym / sponsor ID
- EDCAD-PMS / 492/20
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,059 participants (actual)
- Lead sponsor
- Baker Heart and Diabetes InstituteUniversity, hospital or other
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization to provision of PRS-based or CCS-based risk
| Arm | Type | Receives |
|---|---|---|
| PRS score group | Experimental | Diagnostic Test: Polygenic Risk ScoreRisk information provided on the basis of Polygenic Risk Score combined with the Pooled Cohort Equation |
| CCS score group | Active comparator | Diagnostic Test: Coronary Calcium ScoreRisk information provided on the basis of Coronary Calcium Score combined with the Pooled Cohort Equation |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Asymptomatic subjects age 40-70y
- Statin naïve
- TC ≤ 6.5 mmol/L and LDLC <5 mmol/L, and
- 5 year Australian risk ≥2%.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polygenic Risk ScoreRisk description to patient based on PRS | Diagnostic test | PRS score group |
| Coronary Calcium ScoreRisk description to patient based on CCS | Diagnostic test | CCS score group |
Primary outcome
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
1 secondary outcome
Medication adherence in each group
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: No. Data sharing based available on application to the study PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas H Marwick, MD, PhD, MPH principal investigator
Baker Heart and Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polygenic Risk Score and Coronary Calcium Score in people with Coronary Artery Disease, run by Baker Heart and Diabetes Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiovascular risk in each group (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.