Role of the Screening with Coronary Computed Tomography Angiography on Lipid Management and Risk Factors Control in an Asymptomatic Chinese Population: a Community-based, Prospective Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,400
- 试验地点
- 1
- 主要终点
- The proportion of participants taking lipid-lowering medication regularly at both 6 and 12 months
研究概览
简要总结
The primary objective of this study is to determine whether coronary computed tomography angiography (CCTA) -based coronary heart disease(CHD) prevention strategy improves lipid-lowering treatment and cardiovascular risk factor control compared with traditional CHD prevention strategy, guided by a cardiovascular risk score.
详细描述
At present, doctors usually use a "risk score" to identify people at risk of heart disease who may benefit from medical treatment. In the RESPECT study the investigator will compare this "risk score" to coronary CTA scan. In this study the investigator would like to determine the effect of coronary CTA scan on lipid-lowering treatment and cardiovascular risk factor control.
This study will recruit 3400 eligible community volunteers (asymptomatic individuals free of any known cardiovascular event) aged 40 to 69 years, then, randomized (1:1) them to receive individualized primary prevention programs for coronary heart disease based on CCTA results or traditional risk score, as recommended in the Chinese CVD prevention guidelines. The intervention strategies in this study are consistent with RESPECT trial.
The investigator will assess the difference of lipid-lowering treatment and cardiovascular risk factor control between two groups 12 months later. Furthermore, the investigator will present the results of subclinical coronary atherosclerosis in participants who have undergone coronary CTA scans. This will help us understand the prevalence of subclinical coronary atherosclerotic disease in an asymptomatic Chinese population.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nanjing residents who have no plans to leave in the next 5 years
- •Aged from 40 to 69 years
- •Free of any known clinically cardiovascular disease Able to comprehend and sign an informed consent form
排除标准
- •Serious liver dysfunction, defined as AST or ALT > 3 times the normal upper limit
- •Chronic kidney disease (CKD) > stage 4, defined as eGFR < 30 ml/min/1.73 m2
- •Prior CCTA or invasive coronary angiography within the last 5 years
- •Any contraindications for CCTA
- •Previous use of statin or non-statin lipid-lowering medication (such as ezetimibe, PCSK9 inhibitor and XueZhiKang)
- •Life expectancy < 3 years
- •Other reasons the researcher deems inappropriate to attend
研究组 & 干预措施
CCTA-based strategy group
Subjects will be managed following the CCTA -based coronary heart disease prevention strategy for lipid-lowering treatment and follow-up.
干预措施: Coronary Computed Tomography Angiography (Diagnostic Test)
Chinese guidelines for lipid management (2023)
The baseline assessment will be completed on the same day as consent is gained. Every subjects will complete a comprehensive assessment including questionnaires and objective assessments.
干预措施: Traditional cardiovascular risk stratification (Other)
结局指标
主要结局
The proportion of participants taking lipid-lowering medication regularly at both 6 and 12 months
时间窗: 12 months
Taking lipid-lowering medication regularly defined as taking the established lipid-lowering medication (including statin, ezetimibe, xuezhikang and PCSK9 inhibitor) at least 24 days during the past 30 days.
次要结局
- The proportion of participants achieving LDL-C targets at 12 months(12 months)
- The proportion of participants taking lipid-lowering medication regularly at 12 months.(12 months)
- Cardiovascular events(12 months)
- Prevalence of subclinical coronary atherosclerotic disease(baseline)
- LDL-C levels(12 months)
- Hypertension control(12 months)
- Diabetic control(12 months)
- Smoking cessation(12 months)
- Exercise(12 months)
- Quality of life/Anxiety and Depression(12 months)
研究者
Zhang longjiang,MD
Principal Investigator : Zhang longjiang
Jinling Hospital, China