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

Monash University

Status: Enrolling

Conditions: Type 2 Diabetes Mellitus (T2DM); Cardiovascular Diseases

Treatments: Other: PRS results; Other: CTCA results

Study type: Interventional

Funder types: Other

Identifiers

NCT07091162

VOLTAIRE-1

Details and patient eligibility

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

1. CTCA group

Active Comparator group

Description:

Participants receive baseline CTCA results, in addition to standard care

Treatment:

Other: CTCA results

2. PRS group

Active Comparator group

Description:

Participants receive polygenic risk score result, in addition to standard care

Treatment:

Other: PRS results

3. Control group

No Intervention group

Description:

Participants receive standard care only with no additional information