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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: CTA-guided Intensive Intervention Strategy; Other: Comprehensive Intervention Strategy

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 14980
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Daqing, Heilongjiang, China, 163001
      • DaQing Oilfield Hospital
    • Daqing, Heilongjiang, China, 163453
      • Daqing Longnan Hospital
    • Harbin, Heilongjiang, China, 150086
      • The Second Affiliated Hospital of Harbin Medical University
    • Harbin, Heilongjiang, China, 150088
      • Beidahuang Industry Group General Hospital
    • Harbin, Heilongjiang, China, 150036
      • Heilongjiang Provincial Hospital, China
    • Hegang, Heilongjiang, China, 154211
      • The Baoquanling Hospital of Beidahuang Group
    • Hegang, Heilongjiang, China, 154100
      • Hegang People Hospital
    • Jiamusi, Heilongjiang, China, 154002
      • Jiamusi Central Hospital
    • Jiamusi, Heilongjiang, China, 154003
      • The First Affiliated Hospital of Jiamusi University, China
    • Mudanjiang, Heilongjiang, China, 157011
      • Hongqi Hospital Affiliated to Mudanjiang Medical University
    • Mudanjiang, Heilongjiang, China, 157011
      • Mudanjiang Cardiovascular Hospital, China
    • Qiqihar, Heilongjiang, China, 161005
      • The First Hospital of Qiqihar
    • Qiqihar, Heilongjiang, China, 161000
      • The Third Affiliated Hospital of Qiqihar Medical University
    • Shuangyashan, Heilongjiang, China, 155100
      • Shuangyashan Shuangkuang Hospital
    • Suihua, Heilongjiang, China, 152000
      • The First Hospital of Suihua City
  • Municipality of Beijing
    • Beijing, Municipality of Beijing, China, 100080
      • Beijing Peking University WBL Biotech Co., Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CTA-guided Group; CTA-guided intensive intervention strategy (participants will have their treatment recommendations based on the result of CTA examination)	Diagnostic test: CTA-guided Intensive Intervention Strategy; Intensive intervention strategies based on the result of coronary computed tomography angiography
Active Comparator: Standard Care Group; Standard comprehensive intervention strategy	Other: Comprehensive Intervention Strategy; Comprehensive intervention strategies based on guidelines and expert consensus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	Time to first occurrence of any of the following: all-cause death, non-fatal myocardial infarction, or non-fatal stroke	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause death	Number of cardiovascular and non-cardiovascular death	18 months
Myocardial infarction	Number of fatal and non-fatal myocardial infarction	18 months
Stroke	Number of fatal and non-fatal stroke	18 months
Hospitalization for chest pain	Number of hospitalization due to cardiac chest pain and hospitalization due to non-cardiac chest pain	18 months
Coronary revascularization	Number of percutaneous coronary intervention and coronary artery bypass grafting procedures	18 months
Invasive coronary angiography	Number of invasive coronary angiography	18 months
The proportion of antiplatelet drugs and lipid-lowering drugs used	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	Changes in TC, LDL-C, HDL-C, and TG	Baseline and 18 months
Change in quality of life (EQ-5D-5L)	Change in quality of life measured using EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire: The first part is a descriptive system, assessing health in five dimensions. Each dimension has 5 levels from no problems to extreme problems (0-5), with higher scores for lower quality of life. The second part consists of a Visual Analogue Scale (VAS), assessing the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher quality of life.	Baseline and 18 months
MACE at 36 months	Time to first occurrence of any of the following: all-cause death, non-fatal myocardial infarction, or non-fatal stroke	36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CTA-related endpoints (allergy and acute kidney injury caused by contrast agent)	Number of allergy and acute kidney injury caused by contrast agent	18 months
Lipid-lowering therapy-related endpoints (hepatotoxic events)	Number of hepatotoxic events	18 months
Lipid-lowering therapy-related endpoints (muscle toxic events)	Number of muscle toxic events	18 months
Lipid-lowering therapy-related endpoints (new onset diabetes)	Number of new onset diabetes	18 months
Antiplatelet therapy-related endpoints	Number of Bleeding Academic Research Consortium (BARC) type 3 or 5	18 months

Collaborators and Investigators

• Sponsor: Harbin Medical University
• Collaborators: Beijing Peking University WBL Biotech Co., Ltd.; Daqing Oil Field Hospital; Daqing Longnan Hospital; The First Hospital Of Qiqihar; Heilongjiang Provicial Hospital; Beidahuang Industry Group General Hospital; Mudanjiang Cardiovascular Hospital, China; Hongqi Hospital Affiliated to Mudanjiang Medical University; The Third Affiliated Hospital of Qiqihar Medical University; The Baoquanling Hospital of Beidahuang Group; The First Hospital of Suihua City; Jiamusi Central Hospital; The First Affiliated Hospital of Jiamusi University, China; Shuangyashan Shuangkuang Hospital; Hegang People Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: February 14, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Atherosclerosis; Prevention; Computed Tomography Angiography; High Risk Cardiovascular Disease Population
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Atherosclerosis
• Other Study ID Numbers: 2024ZD0537902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No