EValuation Of poLygenic Scores and CT imAging In Risk Factor Modification in Patients With diabEtes
NCT ID: NCT07091162
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2023-07-25
2026-08-31
Brief Summary
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Detailed Description
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VOLTAIRE evaluates whether integrating CTCA and PRS into risk counselling enhances adherence to lifestyle and pharmacological interventions, ultimately improving cardiovascular outcomes among patients with T2D.
VOLTAIRE is a prospective three-arm, parallel-group, randomised controlled trial aiming to enrol 90 participants aged 40 years or older with T2D and no established atherosclerotic CVD. Participants will be randomised 1:1:1 to receive: (1) risk factor counselling plus CTCA result, (2) risk factor counselling plus PRS result or (3) standard risk factor counselling (control). Nurse-led motivational interviewing will be used for risk counselling. The primary outcome is change in non-calcified plaque volume measured by serial CTCA at 12 months. Secondary outcomes include low-density lipoprotein cholesterol levels, adherence to medication, patient engagement, CVD knowledge improvements, and psychological outcomes over 12 months.
VOLTAIRE seeks to determine if coupling nurse-led risk factor counselling with personalised CTCA or PRS information improves cardiovascular outcomes, adherence, and participant engagement in T2D management.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1. CTCA group
Participants receive baseline CTCA results, in addition to standard care
CTCA results
Participants who are assigned to CTCA group will receive their CTCA results
2. PRS group
Participants receive polygenic risk score result, in addition to standard care
PRS results
Participants who are assigned to PRS group will receive their PRS results
3. Control group
Participants receive standard care only with no additional information
No interventions assigned to this group
Interventions
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CTCA results
Participants who are assigned to CTCA group will receive their CTCA results
PRS results
Participants who are assigned to PRS group will receive their PRS results
Eligibility Criteria
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Inclusion Criteria
* Established diagnosis of T2DM
* Having acceptable imaging quality as deemed by the VHI-AICL
* Able to have a PRS calculated
Exclusion Criteria
* 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
40 Years
ALL
No
Sponsors
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Monash University
OTHER
Responsible Party
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Stephen Nicholls
Professor
Principal Investigators
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Stephen J Nicholls, MBBS, PhD
Role: PRINCIPAL_INVESTIGATOR
Monash University
Locations
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Victorian Heart Hospital
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VOLTAIRE-1
Identifier Type: -
Identifier Source: org_study_id
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