Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04604353




Registration number
NCT04604353
Ethics application status
Date submitted
19/10/2020
Date registered
27/10/2020
Date last updated
22/08/2024

Titles & IDs
Public title
Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk Scoring
Scientific title
Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk Scoring in at Risk Patients: Comparison With Coronary Computed Tomography
Secondary ID [1] 0 0
492/20
Universal Trial Number (UTN)
Trial acronym
EDCAD-PMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in cardiovascular risk in each group
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Medication adherence in each group
Timepoint [1] 0 0
12 months

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%.
Minimum age
40 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/12/2023
Sample size
Target
Accrual to date
Final
1059
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04604353
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas H Marwick, MD, PhD, MPH
Address 0 0
Baker Heart and Diabetes Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carla Duarte, BS
Address 0 0
Country 0 0
Phone 0 0
+61385321550
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04604353