EValuation Of poLygenic Scores and CT imAging In Risk Factor Modification in Patients With diabEtes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CTCA results, PRS results.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases, Type 2 Diabetes Mellitus (T2DM). Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
The contemporary management of type 2 diabetes (T2D) involves a multifaceted model of care integrating intensive management of lipids, blood pressure, and glucose, along with lifestyle modifications. Despite these efforts, cardiovascular disease (CVD) remains a leading cause of morbidity and mortality among patients with T2D, largely due to suboptimal adherence to preventive strategies. The VOLTAIRE trial aims to assess the impact of providing personalised cardiovascular risk information derived from computed tomography coronary angiography (CTCA) and a polygenic risk score (PRS) on cardiovascular risk factor modification.
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.
Interventions
- Other CTCA results
Participants who are assigned to CTCA group will receive their CTCA results - Other PRS results
Participants who are assigned to PRS group will receive their PRS results
Primary outcome measures
- Change in non-calcified plaque volume, with Bonferroni correction at 12 months [Time frame: From baseline CT to the end of study at 12 months]
Secondary outcome measures (12)
- Number of Participants achieving LDL-C <1.8 mmol/L [Time frame: 12 months]
- Number of Participants who undergo intensification of lipid-lowering therapy [Time frame: 12 months]
- Number of participants reporting high levels of adherence to their prescribed medications [Time frame: 12 months]
- Change in level of patient activation and engagement in their care, measured by PAM-13 questionnaire [Time frame: 12 months]
- Change in depressive symptoms, measured by the Patient Health Questionnaire-9 (PHQ-9) [Time frame: 12 months]
- Change in anxiety symptoms, measured by the Generalized Anxiety Disorder-7 (GAD-7) scale [Time frame: 12 months]
- Change in diabetes-related emotional distress, measured by the Diabetes Distress Scale (DDS-17) [Time frame: 12 months]
- Change in health-related quality of life, measured by the EQ-5D-5L [Time frame: 12 months]
- Change in risk of obstructive sleep apnea, measured by the STOP-BANG questionnaire [Time frame: 12 months]
- Change in estimated 5-year cardiovascular disease (CVD) risk, measured by the NZSSD CVD Risk Calculator [Time frame: 12 months]
- Incidence of CVD events [Time frame: 12 months]
- Number of participants achieving all three modifiable risk factor goals: LDL-C <1.8mmol/L, systolic blood pressure ≤130mmHg, and smoking cessation [Time frame: 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Australia · 1 center
- Victorian Heart Hospital — Melbourne
Publications
- Chen RT, Nelson AJ, Zoungas S, Clark RA, Tan S, Davis EF, Southey MC, Lin A, Di Giovanni G, Fujino M, Wong J, O'Reilly RL, Dron JS, Nicholls SJ. Baseline Computed Tomography Coronary Angiography and Polygenic Risk Profiles in Adults With Type 2 Diabetes: A Cross-Sectional Analysis From the VOLTAIRE Study. Diabetes Obes Metab. 2026 Jul 8. doi: 10.1111/dom.71072. Online ahead of print. PMID 42420749
Identifiers
NCT: NCT07091162 · VOLTAIRE-1