Cardiovascular Risk Assessment and dynamIc Monitoring-based Prevention Trial for prImary Care quALity evaLuation in Yinzhou
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 22,032
- 试验地点
- 1
- 主要终点
- Primary Outcome of Phase I: Change in cardiovascular risk score
研究概览
简要总结
The CRITICALLY study is a cluster randomized trial that will evaluate the effectiveness of a risk-based dynamic monitoring strategy for the primary prevention of cardiovascular high-risk Chinese adults.
详细描述
The objective of the study is to evaluate the effectiveness of a risk-based management strategy on cardiovascular risk scores (calculated by the 2019 WHO cardiovascular risk charts) in 24 months (Phase I) and the incidence of major adverse cardiovascular events in 60 months (Phase II). Totally 216 clinics in Yinzhou District, China will be randomized to the intervention or the control arms with usual care. The interventions supported by the web-based decision support system include (1) cardiovascular risk assessment, (2) dynamic risk monitoring, and (3) regular visits by the general practitioner every three months. Only usual care will be provided in the control arm. The primary outcome is the change in cardiovascular risk scores for Phase I and the incidence of the composite endpoint of coronary heart disease, stroke, heart failure and all-cause mortality for Phase II. If the comprehensive strategy is proven effective, it could provide evidence for the primary prevention of cardiovascular diseases using digital health technology.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Residents in the Yinzhou District have a unique health ID;
- •Aged 40 to 79 years at the baseline enrollment;
- •With high risk of cardiovascular disease evaluated by the 2019 WHO laboratory-based risk models (10-year risk≥10%);
排除标准
- •Have a history of coronary heart disease, stroke or heart failure;
- •Patients with a diagnosis of cancer;
- •Refused to provide written informed consent
结局指标
主要结局
Primary Outcome of Phase I: Change in cardiovascular risk score
时间窗: 24 months after baseline
The change in cardiovascular risk scores calculated by 2019 WHO laboratory-based risk charts
Primary Outcome of Phase II: Major adverse cardiovascular events (MACE)
时间窗: 60 months after baseline
Incidence of coronary heart disease, stroke, heart failure and all-cause mortality
次要结局
- Secondary Outcome of Phase II: Change in health-related quality of life(60 months after baseline)
- Secondary Outcome of Phase I: Change in systolic blood pressure(24 months after baseline)
- Secondary Outcome of Phase I: Change in total cholesterol(24 months after baseline)
- Secondary Outcome of Phase I: Change in low-density lipoprotein cholesterol(24 months after baseline)
研究者
Pei Gao
Professor
Peking University