EValuation Of poLygenic Scores and CT imAging In Risk Factor Modification in Patients With diabEtes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in non-calcified plaque volume, with Bonferroni correction at 12 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
2. PRS group
Participants receive polygenic risk score result, in addition to standard care
干预措施: PRS results (Other)
1. CTCA group
Participants receive baseline CTCA results, in addition to standard care
干预措施: CTCA results (Other)
3. Control group
Participants receive standard care only with no additional information
结局指标
主要结局
Change in non-calcified plaque volume, with Bonferroni correction at 12 months
时间窗: From baseline CT to the end of study at 12 months
次要结局
- Number of Participants achieving LDL-C <1.8 mmol/L(12 months)
- Change in level of patient activation and engagement in their care, measured by PAM-13 questionnaire(12 months)
- Number of Participants who undergo intensification of lipid-lowering therapy(12 months)
- Change in depressive symptoms, measured by the Patient Health Questionnaire-9 (PHQ-9)(12 months)
- Change in anxiety symptoms, measured by the Generalized Anxiety Disorder-7 (GAD-7) scale(12 months)
- Number of participants reporting high levels of adherence to their prescribed medications(12 months)
- Change in diabetes-related emotional distress, measured by the Diabetes Distress Scale (DDS-17)(12 months)
- Change in health-related quality of life, measured by the EQ-5D-5L(12 months)
- Change in risk of obstructive sleep apnea, measured by the STOP-BANG questionnaire(12 months)
- Change in estimated 5-year cardiovascular disease (CVD) risk, measured by the NZSSD CVD Risk Calculator(12 months)
- Incidence of CVD events(12 months)
- Number of participants achieving all three modifiable risk factor goals: LDL-C <1.8mmol/L, systolic blood pressure ≤130mmHg, and smoking cessation(12 months)
- Change in hsCRP(12 months)
- Change in HbA1c(12 months)
- Change in total atheroma volume (TAV) measured by CTCA(12 months)
- Change in calcified plaque volume measured by CTCA(12 months)
- Change in pericoronary adipose tissue (PCAT) CT attenuation(12 months)
研究者
Stephen Nicholls
Professor
Monash University