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

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.

• Number of Participants achieving LDL-C <1.8 mmol/L [Срок оценки: 12 months]
• Number of Participants who undergo intensification of lipid-lowering therapy [Срок оценки: 12 months]
• Number of participants reporting high levels of adherence to their prescribed medications [Срок оценки: 12 months]
• Change in level of patient activation and engagement in their care, measured by PAM-13 questionnaire [Срок оценки: 12 months]
• Change in depressive symptoms, measured by the Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: 12 months]
• Change in anxiety symptoms, measured by the Generalized Anxiety Disorder-7 (GAD-7) scale [Срок оценки: 12 months]
• Change in diabetes-related emotional distress, measured by the Diabetes Distress Scale (DDS-17) [Срок оценки: 12 months]
• Change in health-related quality of life, measured by the EQ-5D-5L [Срок оценки: 12 months]
• Change in risk of obstructive sleep apnea, measured by the STOP-BANG questionnaire [Срок оценки: 12 months]
• Change in estimated 5-year cardiovascular disease (CVD) risk, measured by the NZSSD CVD Risk Calculator [Срок оценки: 12 months]
• Incidence of CVD events [Срок оценки: 12 months]
• Number of participants achieving all three modifiable risk factor goals: LDL-C <1.8mmol/L, systolic blood pressure ≤130mmHg, and smoking cessation [Срок оценки: 12 months]