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Search / Trial NCT07091162

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

Launched by MONASH UNIVERSITY · Jul 21, 2025

Trial Information

Current as of November 10, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how two different tools—a heart scan called cardiac CT imaging and a genetic test called a polygenic risk score—can help improve heart health in people with type 2 diabetes. The goal is to see if using these tools can better guide treatments to lower the risk of heart problems in patients with diabetes.

People who are 40 years or older with type 2 diabetes may be able to join the study, as long as they can safely have the heart scan and genetic test done. Participants should not already have known heart disease or serious blockages in their heart arteries. If you join, you will be randomly assigned to one of three groups to see how these tests might influence your care. The study will follow you over time to check how well the approach works. This research is currently recruiting participants, and it aims to find better ways to protect heart health in people living with diabetes.

Gender

ALL

Eligibility criteria

  • 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

About Monash University

Monash University, a leading research institution located in Melbourne, Australia, is dedicated to advancing health and medical knowledge through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, Monash University leverages its extensive expertise in fields such as medicine, pharmacy, and biomedical sciences to conduct rigorous, ethically sound research aimed at improving patient outcomes. The university is committed to fostering a research environment that supports the translation of scientific discoveries into practical applications, ensuring that its clinical trials contribute meaningfully to the global body of medical knowledge.

Locations

Melbourne, Victoria, Australia

Patients applied

0 patients applied

Trial Officials

Stephen J Nicholls, MBBS, PhD

Principal Investigator

Monash University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported