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

Enrolling by invitation · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT07416344

Run by

Harbin Medical University

People needed

14980

Starts

2026-04-27

Expected to finish

2030-04-01

Last updated by the study team

2026-06-15

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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] 5. Sign the informed consent

You may not qualify if…

• 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

Where it is running

• DaQing Oilfield Hospital — Daqing, Heilongjiang, China
• Daqing Longnan Hospital — Daqing, Heilongjiang, China
• Heilongjiang Provincial Hospital, China — Harbin, Heilongjiang, China
• The Second Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China
• Beidahuang Industry Group General Hospital — Harbin, Heilongjiang, China
• Hegang People Hospital — Hegang, Heilongjiang, China
• The Baoquanling Hospital of Beidahuang Group — Hegang, Heilongjiang, China
• Jiamusi Central Hospital — Jiamusi, Heilongjiang, China
• The First Affiliated Hospital of Jiamusi University, China — Jiamusi, Heilongjiang, China
• Hongqi Hospital Affiliated to Mudanjiang Medical University — Mudanjiang, Heilongjiang, China
• Mudanjiang Cardiovascular Hospital, China — Mudanjiang, Heilongjiang, China
• The Third Affiliated Hospital of Qiqihar Medical University — Qiqihar, Heilongjiang, China
• The First Hospital of Qiqihar — Qiqihar, Heilongjiang, China
• Shuangyashan Shuangkuang Hospital — Shuangyashan, Heilongjiang, China
• The First Hospital of Suihua City — Suihua, Heilongjiang, China
• Beijing Peking University WBL Biotech Co., Ltd — Beijing, Municipality of Beijing, China

Full record on ClinicalTrials.gov

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