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NCT Number: NCT07181512

Deep Learning CAD Screening on Chest CT

Coronary artery disease (CAD) is one of the leading causes of death worldwide. Many people have early atherosclerosis without symptoms, and some may develop significant coronary stenosis before any warning signs appear. Identifying high-risk individuals at an early stage is important to prevent heart attacks and other cardiovascular events.

Coronary CT angiography (CCTA) can directly evaluate plaque type and the degree of narrowing in the coronary arteries, but it is expensive, requires contrast injection, and involves higher radiation, making it unsuitable for large-scale screening. In contrast, non-contrast chest CT is widely used for health check-ups and lung disease follow-up. Such scans often provide clear views of certain coronary segments, which creates an opportunity to screen for CAD without additional cost or risk.

This multicenter study aims to develop and validate deep learning models to analyze coronary calcified segments that are visible on non-contrast chest CT. Two main objectives are: (1) to predict whether calcified segments contain mixed plaque components (both calcified and non-calcified); and (2) to predict whether these segments have significant narrowing (≥50% stenosis) as determined by CCTA. The study will also describe how often ≥50% stenosis is found in non-calcified segments, in order to demonstrate their low-risk nature.

The study includes retrospective data collected between 2015 and 2024, and a prospective external validation cohort starting in 2025. Approximately 1,417 patients with paired chest CT and CCTA have already been included for model development and testing. An additional 200 or more patients will be prospectively recruited for external validation.

This research may provide evidence that deep learning applied to routine non-contrast chest CT can serve as an opportunistic tool for early CAD risk screening in the general population.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China

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About this study

This study involves analysis of imaging data obtained from patients who undergo non-contrast chest CT and CCTA as part of their routine clinical care. No additional imaging, radiation, or intervention is performed. The institutional review board approved the study and waived the requirement for written informed consent due to minimal risk and use of de-identified data.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Patients who underwent both non-contrast chest CT and coronary CT angiography (CCTA) within 30 days
  • Coronary segments clearly visualized on non-contrast chest CT

Exclusion criteria

  • Segments with motion artifacts, metal artifacts, or stents preventing analysis
  • Vessel lumen completely obscured by calcification (unrecognizable vascular course)
  • Inability to match coronary segment location between non-contrast chest CT and CCTA

Treatment and study plan

Deep Learning Analysis of Non-contrast Chest CT

Other

Analysis of clearly visualized coronary segments on non-contrast chest CT using deep learning models, compared with CCTA reference standard.

Primary outcomes

  1. Accuracy of plaque composition prediction

    Time frame: Baseline non-contrast chest CT to reference CCTA (within 30 days)

    Discrimination ability of the deep learning model to classify calcified coronary segments as purely calcified or mixed plaque, using CCTA as the reference standard. Evaluated with AUC, sensitivity, specificity.

  2. Accuracy of ≥50% stenosis prediction

    Time frame: Baseline non-contrast chest CT to reference CCTA (within 30 days)

    Discrimination ability of the deep learning model to predict ≥50% luminal stenosis in calcified coronary segments, using CCTA as the reference standard. Evaluated with AUC, sensitivity, specificity, PPV, NPV.

Secondary outcomes

  1. Incidence of ≥50% stenosis in non-calcified segments

    Time frame: Baseline non-contrast chest CT to CCTA (within 30 days)

    Descriptive statistics of ≥50% stenosis prevalence in non-calcified coronary artery segments.

Study contacts

Contact information is provided by the study sponsor or research team.

Yifan Guo, MD

CONTACT

[email protected]

+86-18072947783

Sponsors and collaborators

Lead sponsor

Yifan Guo

Other Gov

Collaborators

  • First Affiliated Hospital of Ningbo University
  • Jinhua Municipal Central Hospital
  • The Second Affiliated Hospital of Fujian Medical University

Registry information

Official study title

Deep Learning-Based Opportunistic Screening of Coronary Artery Disease on Non-Contrast Chest CT: A Multicenter Study

Acronym: CAD-AI

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 18, 2025
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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