Evaluation of polygenic scores and ct imaging in risk factor modification in patients with diabetes (VOLTAIRE): rationale and design.

Abstract

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 this comprehensive approach, cardiovascular disease (CVD) remains a leading cause of morbidity and mortality among patients with T2D due to suboptimal adherence to preventive strategies. VOLTAIRE aims to explore the potential of providing participants with personalised counselling through information derived from computed tomography coronary angiography (CTCA) and polygenic risk scores (PRS). Design(s): VOLTAIRE is a three-arm, parallel-group, randomised controlled trial, evaluating the impact of CTCA and PRS on cardiovascular risk factor modification in patients with T2D over 18 months. Participants over 40 years with an established diagnosis of T2D and a low-density lipoprotein cholesterol level >1.8mmol/L are eligible. Key exclusion criteria include known atherosclerotic cardiovascular disease (ASCVD), or significant ASCVD on screening CTCA. Eligible participants will be randomised 1:1:1 to one of three arms: 1) standard risk factor counselling alone, 2) risk factor counselling plus CTCA plaque burden, or 3) risk factor counselling plus PRS information. Risk factor counselling will be undertaken using a nurse-led program based in motivational interviewing. Outcome(s): The primary outcome is change in non-calcified plaque volume using CTCA. Secondary outcomes include proportion achieving risk factor control, adherence to medications, patient engagement, and psychological health scores. Conclusion(s): VOLTAIRE will determine whether coupling nurse-led risk factor management with the provision of personalised information from innovative technologies can enhance cardiovascular outcomes as well as participant engagement and adherence. VOLTAIRE is actively recruiting in Melbourne.Copyright © 2024