Recruiting
EValuation Of poLygenic Scores and CT imAging In Risk Factor Modification in Patients With diabEtes
This study is a three-arm, parallel-group, randomised controlled trial evaluating the effect of using cardiac CT imaging or polygenic risk score in cardiovascular risk factor modification in patients with diabetes.
ClinicalTrials.gov IDNCT07091162
PhaseNA
Enrollment90
SponsorMonash University
Age40 Years
SexALL
Conditions studied
Cardiovascular Diseases, Type 2 Diabetes Mellitus (T2DM)
About this study
This study is a three-arm, parallel-group, randomised controlled trial evaluating the effect of using cardiac CT imaging or polygenic risk score in cardiovascular risk factor modification in patients with diabetes.
Interventions
- Other: CTCA results — Participants who are assigned to CTCA group will receive their CTCA results
- Other: PRS results — Participants who are assigned to PRS group will receive their PRS results
Primary outcomes
- Change in non-calcified plaque volume, with Bonferroni correction at 12 months (From baseline CT to the end of study at 12 months)
Eligibility information
Inclusion Criteria:
* Age 40 years or older
* Established diagnosis of T2DM
* Having acceptable imaging quality as deemed by the VHI-AICL
* Able to have a PRS calculated
Exclusion Criteria:
* Unable to provide written informed consent.
* Unwilling to be followed for serial evaluation
* Clinically manifest CV disease
* Evidence of clinically significant coronary disease on CT that would preclude masking from participant's treating clinician for the duration of the study on the grounds of safety, including but not limited to, equal/greater than 50% in the left main coronary artery or equal/greater than 70% in any epicardial coronary artery
* Unable to participate in the study or complete protocol required assessments in the opinion of the Investigator
Study locations
- Victorian Heart Hospital, Melbourne, Victoria 3168 Australia
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-03.