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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04604353
Registration number
NCT04604353
Ethics application status
Date submitted
19/10/2020
Date registered
27/10/2020
Date last updated
28/09/2023
Titles & IDs
Public title
Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk Scoring
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Scientific title
Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk Scoring in at Risk Patients: Comparison With Coronary Computed Tomography
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Secondary ID [1]
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492/20
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Universal Trial Number (UTN)
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Trial acronym
EDCAD-PMS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Diagnosis / Prognosis - Polygenic Risk Score
Diagnosis / Prognosis - Coronary Calcium Score
Experimental: PRS score group - Risk information provided on the basis of Polygenic Risk Score combined with the Pooled Cohort Equation
Active Comparator: CCS score group - Risk information provided on the basis of Coronary Calcium Score combined with the Pooled Cohort Equation
Diagnosis / Prognosis: Polygenic Risk Score
Risk description to patient based on PRS
Diagnosis / Prognosis: Coronary Calcium Score
Risk description to patient based on CCS
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in cardiovascular risk in each group
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Assessment method [1]
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Change in cardiovascular risk (expressed as pooled cohort equation 10-year risk percentage) from baseline to follow-up
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Medication adherence in each group
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Assessment method [1]
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Proportion of lipid-lowering tablets taken
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Timepoint [1]
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12 months
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Eligibility
Key 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%.
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Minimum age
40
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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).
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/12/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/10/2023
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Actual
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Sample size
Target
948
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Baker Heart and Diabetes Institute - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Baker Heart and Diabetes Institute
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04604353
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Thomas H Marwick, MD, PhD, MPH
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Address
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Baker Heart and Diabetes Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Carla Duarte, BS
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Address
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Country
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Phone
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+61385321550
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04604353
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