Using heart CT scans and genetic risk scores to guide heart disease prevention in people with type 2 diabetes
EValuation Of poLygenic Scores and CT imAging In Risk Factor Modification in Patients With diabEtes
This trial will test whether giving people with type 2 diabetes either a heart CT scan result or a genetic risk score helps them stick to medicines and lifestyle changes and reduce early coronary plaque.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Monash University Academic / other |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT07091162 on ClinicalTrials.gov |
What this trial studies
VOLTAIRE is a prospective, three-arm, parallel-group randomized controlled trial enrolling 90 adults aged 40 years or older with type 2 diabetes and no established atherosclerotic cardiovascular disease. Participants are randomized 1:1:1 to receive risk counselling plus CT coronary angiography (CTCA) results, risk counselling plus a polygenic risk score (PRS) result, or standard risk counselling, with nurse-led motivational interviewing used for counselling sessions. The primary outcome is change in non-calcified plaque volume measured by serial CTCA at 12 months, and secondary outcomes include LDL cholesterol, medication adherence, and patient engagement. The trial is conducted at the Victorian Heart Hospital in Melbourne and excludes patients with clinically manifest cardiovascular disease or CT findings that require immediate clinical action.
Who should consider this trial
Good fit: Adults aged 40 years or older with type 2 diabetes, no known atherosclerotic cardiovascular disease, acceptable CT imaging quality, and who can have a PRS calculated and attend follow-up visits are the ideal candidates.
Not a fit: People with established coronary artery disease, CT findings that require immediate clinical management, inability to undergo CT imaging, or inability to complete follow-up are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could help people with type 2 diabetes better follow preventive treatments and slow progression of early coronary plaque, potentially lowering future heart attack risk.
How similar studies have performed: Personalized CT imaging to inform risk has prior evidence of changing management and behavior, polygenic risk scoring is an emerging approach with mixed early results, and combining CTCA and PRS for behavior change is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Melbourne, Victoria
- Victorian Heart Hospital — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Stephen J Nicholls, MBBS, PhD — Monash University
- Study coordinator: Domenic Sacca
- Email: domenic.sacca@monash.edu
- Phone: 0423245187
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.