The VOLTAIRE trial is an ongoing randomized controlled trial designed to evaluate whether integrating CTCA or polygenic risk scores into risk counseling improves outcomes in type 2 diabetes.
RCT
1:1:1
Does integrating CTCA or PRS into risk counseling reduce non-calcified plaque volume in patients aged 40 years or older with T2D and no established atherosclerotic CVD?
The VOLTAIRE trial will determine if providing personalized cardiovascular risk information from CTCA or polygenic risk scores improves adherence and reduces non-calcified plaque volume in patients with type 2 diabetes.
BACKGROUND: 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 personalized cardiovascular risk information derived from computed tomography coronary angiography (CTCA) and a polygenic risk score (PRS) on cardiovascular risk factor modification. OBJECTIVES: VOLTAIRE evaluates whether integrating CTCA and PRS into risk counseling enhances adherence to lifestyle and pharmacological interventions, ultimately improving cardiovascular outcomes among patients with T2D. METHODS: VOLTAIRE is a prospective three-arm, parallel-group, randomized controlled trial enrolling participants aged 40 years or older with T2D and no established atherosclerotic CVD. Participants are randomized 1:1:1 to receive: (1) risk factor counseling plus CTCA result, (2) risk factor counseling plus PRS result, or (3) standard risk factor counseling (control). Nurse-led motivational interviewing is used for risk counseling. 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. Enrollment began in August 2023. DISCUSSION: VOLTAIRE seeks to determine if coupling nurse-led risk factor counseling with personalized CTCA or PRS information improves cardiovascular outcomes, adherence, and participant engagement in T2D management.
Chen et al. (Mon,) conducted a rct in Type 2 diabetes. Risk factor counseling plus CTCA result or PRS result vs. Standard risk factor counseling was evaluated on Change in non-calcified plaque volume measured by serial CTCA at 12 months. The VOLTAIRE trial is an ongoing randomized controlled trial designed to evaluate whether integrating CTCA or polygenic risk scores into risk counseling improves outcomes in type 2 diabetes.