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Coronary Artery DiseaseCARDIACNCT07416344

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

A study testing CTA-guided Intensive Intervention Strategy and Comprehensive Intervention Strategy in people with Coronary Artery Disease, run by Harbin Medical University at 16 sites in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
CTA-guided Intensive Intervention Strategy and Comprehensive Intervention Strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14,980 participants
Where
16 sitesChina
Study dates
27 Apr 2026to Apr 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.)
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  • 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

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

16 sites in 1 country

China16 sites

  • Beijing Peking University WBL Biotech Co., Ltd

    Beijing, Municipality of Beijing, 100080

  • DaQing Oilfield Hospital

    Daqing, Heilongjiang, 163001

  • Daqing Longnan Hospital

    Daqing, Heilongjiang, 163453

  • Heilongjiang Provincial Hospital, China

    Harbin, Heilongjiang, 150036

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086

  • Beidahuang Industry Group General Hospital

    Harbin, Heilongjiang, 150088

  • Hegang People Hospital

    Hegang, Heilongjiang, 154100

  • The Baoquanling Hospital of Beidahuang Group

    Hegang, Heilongjiang, 154211

  • Jiamusi Central Hospital

    Jiamusi, Heilongjiang, 154002

  • The First Affiliated Hospital of Jiamusi University, China

    Jiamusi, Heilongjiang, 154003

  • Hongqi Hospital Affiliated to Mudanjiang Medical University

    Mudanjiang, Heilongjiang, 157011

  • Mudanjiang Cardiovascular Hospital, China

    Mudanjiang, Heilongjiang, 157011

  • The Third Affiliated Hospital of Qiqihar Medical University

    Qiqihar, Heilongjiang, 161000

  • The First Hospital of Qiqihar

    Qiqihar, Heilongjiang, 161005

  • Shuangyashan Shuangkuang Hospital

    Shuangyashan, Heilongjiang, 155100

  • The First Hospital of Suihua City

    Suihua, Heilongjiang, 152000

Other trials in China

About this study

Official title: 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.

Read the 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).

Being tested
CTA-guided Intensive Intervention Strategy, Comprehensive Intervention Strategy
Keywords
Coronary Artery Disease, Computed Tomography Angiography, High Risk Cardiovascular Disease Population, Prevention, Atherosclerosis
Medical subject headings
Coronary Artery Disease, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CTA-guided Intensive Intervention StrategyDiagnostic test

    Intensive intervention strategies based on the result of coronary computed tomography angiography

  • Comprehensive Intervention StrategyOther

    Comprehensive intervention strategies based on guidelines and expert consensus

Study groups in NCT07416344
Study groupRoleWhat they receive
CTA-guided GroupExperimentalCTA-guided intensive intervention strategy (participants will have their treatment recommendations based on the result of CTA examination)
Receives: Diagnostic Test: CTA-guided Intensive Intervention Strategy
Standard Care GroupActive comparatorStandard comprehensive intervention strategy
Receives: Other: Comprehensive Intervention Strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MACE

    Time to first occurrence of any of the following: all-cause death, non-fatal myocardial infarction, or non-fatal stroke

    Measured: 18 months

Secondary outcomes (10)

  1. All cause death

    Number of cardiovascular and non-cardiovascular death

    Measured: 18 months

  2. Myocardial infarction

    Number of fatal and non-fatal myocardial infarction

    Measured: 18 months

  3. Stroke

    Number of fatal and non-fatal stroke

    Measured: 18 months

  4. Hospitalization for chest pain

    Number of hospitalization due to cardiac chest pain and hospitalization due to non-cardiac chest pain

    Measured: 18 months

  5. Coronary revascularization

    Number of percutaneous coronary intervention and coronary artery bypass grafting procedures

    Measured: 18 months

  6. Invasive coronary angiography

    Number of invasive coronary angiography

    Measured: 18 months

  7. The proportion of antiplatelet drugs and lipid-lowering drugs used

    The proportion of antiplatelet drugs and lipid-lowering drugs used

    Measured: Baseline and 1 month, 3 months, 6 months, 12 months, 18 months

  8. Changes in lipid levels

    Changes in TC, LDL-C, HDL-C, and TG

    Measured: Baseline and 18 months

  9. 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.

    Measured: Baseline and 18 months

  10. MACE at 36 months

    Time to first occurrence of any of the following: all-cause death, non-fatal myocardial infarction, or non-fatal stroke

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2026
  2. Study start27 Apr 2026
  3. Primary completionOct 2028 (estimated)
  4. Study completionApr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
14,980 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07416344
Sponsor's protocol ID
2024ZD0537902
Acronym
CARDIAC
Status last verified
Jun 2026
First submitted
21 Jan 2026
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CTA-guided Intensive Intervention Strategy and Comprehensive Intervention Strategy in people with Coronary Artery Disease, run by Harbin Medical University at 16 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACE (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07416344.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

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