EValuation Of poLygenic Scores and CT imAging In Risk Factor Modification in Patients With diabEtes

Recruiting now · Not applicable

Conditions studied: Cardiovascular Diseases, Type 2 Diabetes Mellitus (T2DM)

In brief

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.

Key facts

Study ID

NCT07091162

Run by

Monash University

People needed

90

Starts

2023-07-25

Expected to finish

2026-08-01

Last updated by the study team

2025-07-29

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Victorian Heart Hospital — Melbourne, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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