A Coronary Computed Tomography Angiography-guided Intervention for High Risk Cardiovascular Disease Population in Rural China
CARDIAC
1 other identifier
interventional
14,980
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Mar 2026
Typical duration for not_applicable coronary-artery-disease
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2026
CompletedFirst Posted
Study publicly available on registry
February 18, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2030
February 18, 2026
February 1, 2026
2.6 years
January 21, 2026
February 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MACE
Time to first occurrence of any of the following: all-cause death, non-fatal myocardial infarction, or non-fatal stroke
18 months
Secondary Outcomes (10)
All cause death
18 months
Myocardial infarction
18 months
Stroke
18 months
Hospitalization for chest pain
18 months
Coronary revascularization
18 months
- +5 more secondary outcomes
Other Outcomes (5)
CTA-related endpoints (allergy and acute kidney injury caused by contrast agent)
18 months
Lipid-lowering therapy-related endpoints (hepatotoxic events)
18 months
Lipid-lowering therapy-related endpoints (muscle toxic events)
18 months
- +2 more other outcomes
Study Arms (2)
CTA-guided Group
EXPERIMENTALCTA-guided intensive intervention strategy (participants will have their treatment recommendations based on the result of CTA examination)
Standard Care Group
ACTIVE COMPARATORStandard comprehensive intervention strategy
Interventions
Intensive intervention strategies based on the result of coronary computed tomography angiography
Comprehensive intervention strategies based on guidelines and expert consensus
Eligibility Criteria
You may qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Baoquanling Hospital of Beidahuang Groupcollaborator
- Daqing Longnan Hospital, Chinacollaborator
- The First Hospital of Suihua Citycollaborator
- Jiamusi Central Hospitalcollaborator
- Beidahuang Industry Group General Hospitalcollaborator
- The First Affiliated Hospital of Jiamusi University, Chinacollaborator
- Shuangyashan Shuangkuang Hospitalcollaborator
- Beijing Peking University WBL Biotech Co., Ltd.collaborator
- Hegang People Hospitalcollaborator
- Harbin Medical Universitylead
- Daqing Oil Field Hospitalcollaborator
- Heilongjiang Provincial Hospital, Chinacollaborator
- The First Hospital Of Qiqiharcollaborator
- Mudanjiang Cardiovascular Hospital, Chinacollaborator
- Hongqi Hospital Affiliated to Mudanjiang Medical Universitycollaborator
- The Third Affiliated Hospital of Qiqihar Medical Universitycollaborator
Study Sites (16)
DaQing Oilfield Hospital
Daqing, Heilongjiang, 163001, China
Daqing Longnan Hospital
Daqing, Heilongjiang, 163453, China
Heilongjiang Provincial Hospital, China
Harbin, Heilongjiang, 150036, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086, China
Beidahuang Industry Group General Hospital
Harbin, Heilongjiang, 150088, China
Hegang People Hospital
Hegang, Heilongjiang, 154100, China
The Baoquanling Hospital of Beidahuang Group
Hegang, Heilongjiang, 154211, China
Jiamusi Central Hospital
Jiamusi, Heilongjiang, 154002, China
The First Affiliated Hospital of Jiamusi University, China
Jiamusi, Heilongjiang, 154003, China
Hongqi Hospital Affiliated to Mudanjiang Medical University
Mudanjiang, Heilongjiang, 157011, China
Mudanjiang Cardiovascular Hospital, China
Mudanjiang, Heilongjiang, 157011, China
The Third Affiliated Hospital of Qiqihar Medical University
Qiqihar, Heilongjiang, 161000, China
The First Hospital of Qiqihar
Qiqihar, Heilongjiang, 161005, China
Shuangyashan Shuangkuang Hospital
Shuangyashan, Heilongjiang, 155100, China
The First Hospital of Suihua City
Suihua, Heilongjiang, 152000, China
Beijing Peking University WBL Biotech Co., Ltd
Beijing, Municipality of Beijing, 100080, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Open-label, assessor-blinded
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
January 21, 2026
First Posted
February 18, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
October 1, 2028
Study Completion (Estimated)
April 1, 2030
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share