EValuation Of poLygenic Scores and CT imAging In Risk Factor Modification in Patients With diabEtes
Recruiting · NCT07091162 · Interventional (participants receive a specific treatment) · Lead sponsor: Monash University
View the official record on ClinicalTrials.gov →Interventions studied
CTCA resultsPRS results
What this trial is about
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.
Who can take part
Age range
40 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Victorian Heart Hospital - Melbourne, Victoria, Australia