A Coronary Computed Tomography Angiography-guided Intervention for High Risk Cardiovascular Disease Population in Rural China

A Coronary Computed Tomography Angiography-guided Intensive Intervention for Population at High Risk for Cardiovascular Disease in Rural China: a Cluster Randomized Controlled Trial

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.

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).

Inclusion Criteria:

Inclusion criteria of study villages:

1. Administrative villages
2. The village has no plans to merge with other villages within 3 years
3. The village is at least 2 kilometers away from other participating villages
4. The village has a sufficient number of study participants
5. The village is able to cooperate with the implementation of the study

Inclusion criteria of study participants:

1. Men or women aged between 40 and 75 years
2. Live stably in the province where the study is conducted and no intention to migrate within next 3 years
3. Not participating in other clinical trials
4. 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] 5. Sign the informed consent

Exclusion Criteria:

1. 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)
2. Typical angina symptoms, known coronary artery disease, or other major atherosclerotic cardiovascular disease
3. Known cerebrovascular disease (e.g., cerebral hemorrhage, cerebral infarction, etc. )
4. Prior invasive or non-invasive coronary angiography within the last 5 years
5. Known familial hypercholesterolemia or other inherited disorders of lipid metabolism requiring lipid-lowering therapy
6. 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.)
7. End-stage diseases such as cirrhosis decompensation, with life expectancy <3 years
8. Have a malignant tumor
9. Intolerance of all statins
10. Lipid-lowering treatment for >2 years
11. Pregnant or breastfeeding, planning to become pregnant within the next 3 years
12. eGFR <30 mL/min/1.73m^2
13. Platelet count <100×10^9/L
14. Poor compliance, unable to cooperate with study investigators
15. Investigators consider unsuitable for participants selected for this study