A Coronary Computed Tomography Angiography-guided Intensive Intervention for Population at High Risk for Cardiovascular Disease in Rural China: a Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 14,980
- 试验地点
- 16
- 主要终点
- MACE
研究概览
简要总结
The CARDIAC trial is a prospective, parallel, open-label cluster randomized trial that aims to determine the effectiveness of a coronary computed tomography angiography (CTA)-guided intensive intervention strategy, as compared with standard care, on reducing the incidence of major adverse events (MACE) at 18 months among high-risk cardiovascular populations in rural China. An extended observational follow-up at 36 months will be conducted to further evaluate the effect on long-term clinical outcomes.
详细描述
The CARDIAC trial aims to determine the effectiveness of a coronary CTA-guided intensive intervention strategy, as compared with standard care, on improving clinical outcomes among population at high risk for cardiovascular disease in rural China. This cluster randomized trial will be conducted in 428 rural villages in China. The study will recruit 35 individuals at high risk for cardiovascular disease from each village for a total of 14,980 participants. The participating villages will be randomly assigned to experimental group (CTA-guided group) and control group (standard care group) with 1:1 allocation. Study participants will be followed at 1, 3, 6, 12, and 18 months. The primary outcome is major adverse cardiovascular events (MACE, a composite of all-cause death, non-fatal myocardial infarction, and non-fatal stroke) at 18 months. In addition, an extended observational follow-up will be conducted at 36 months, to evaluate long-term outcomes (i.e., MACE).
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
盲法说明
Open-label, assessor-blinded
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria of study villages:
- •Administrative villages
- •The village has no plans to merge with other villages within 3 years
- •The village is at least 2 kilometers away from other participating villages
- •The village has a sufficient number of study participants
- •The village is able to cooperate with the implementation of the study
- •Inclusion criteria of study participants:
- •Men or women aged between 40 and 75 years
- •Live stably in the province where the study is conducted and no intention to migrate within next 3 years
- •Not participating in other clinical trials
- •Meet any of the following:
- •(1)Low-Density Lipoprotein Cholesterol (LDL-C) ≥ 4.9 mmol/L or Total Cholesterol (TC) ≥ 7.2 mmol/L (2)Diabetes mellitus (3)Chronic Kidney Disease (CKD) Stage 3-4: estimated Glomerular Filtration Rate (eGFR) 15-59 mL/min/1.73m^2 (4)With a history of hypertension and 3 risk factors, combined with LDL-C ≥ 1.8 mmol/L or TC ≥ 3.1 mmol/L [Risk factors (assessed pre-intervention): smoking, low HDL-C, male ≥ 45 years old or female ≥ 55 years old] (5)With a history of hypertension and 2 risk factors, combined with LDL-C ≥ 2.6 mmol/L or TC ≥ 4.1 mmol/L [Risk factors (assessed pre-intervention): smoking, low HDL-C, male ≥ 45 years old or female ≥ 55 years old]
- •Sign the informed consent
排除标准
- •Unwillingness or inability to undergo coronary CTA examination (e.g., previous history of severe contrast allergy, claustrophobia, or inability to cooperate with scanning and breath-holding for physical reasons in study participants)
- •Typical angina symptoms, known coronary artery disease, or other major atherosclerotic cardiovascular disease
- •Known cerebrovascular disease (e.g., cerebral hemorrhage, cerebral infarction, etc. )
- •Prior invasive or non-invasive coronary angiography within the last 5 years
- •Known familial hypercholesterolemia or other inherited disorders of lipid metabolism requiring lipid-lowering therapy
- •Presence of active bleeding or diseases with a very high risk of bleeding (e.g., active peptic ulcer disease, gastrointestinal pathologies with increased risk of bleeding, hematologic disorders with increased risk of bleeding, etc.)
- •End-stage diseases such as cirrhosis decompensation, with life expectancy <3 years
- •Have a malignant tumor
- •Intolerance of all statins
- •Lipid-lowering treatment for >2 years
- •Pregnant or breastfeeding, planning to become pregnant within the next 3 years
- •eGFR <30 mL/min/1.73m^2
- •Platelet count <100×10^9/L
- •Poor compliance, unable to cooperate with study investigators
- •Investigators consider unsuitable for participants selected for this study
研究组 & 干预措施
CTA-guided Group
CTA-guided intensive intervention strategy (participants will have their treatment recommendations based on the result of CTA examination)
干预措施: CTA-guided Intensive Intervention Strategy (Diagnostic Test)
Standard Care Group
Standard comprehensive intervention strategy
干预措施: Comprehensive Intervention Strategy (Other)
结局指标
主要结局
MACE
时间窗: 18 months
Time to first occurrence of any of the following: all-cause death, non-fatal myocardial infarction, or non-fatal stroke
次要结局
- Stroke(18 months)
- Hospitalization for chest pain(18 months)
- Coronary revascularization(18 months)
- Invasive coronary angiography(18 months)
- All cause death(18 months)
- Myocardial infarction(18 months)
- The proportion of antiplatelet drugs and lipid-lowering drugs used(Baseline and 1 month, 3 months, 6 months, 12 months, 18 months)
- Changes in lipid levels(Baseline and 18 months)
- Change in quality of life (EQ-5D-5L)(Baseline and 18 months)
- MACE at 36 months(36 months)
研究者
Yu Bo
Director
Harbin Medical University