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Recruiting NCT07181512

Deep Learning CAD Screening on Chest CT

Observational Coronary Artery Disease Coronary Artery Stenosis Stent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deep Learning Analysis of Non-contrast Chest CT.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Coronary Artery Stenosis Stent. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other Deep Learning Analysis of Non-contrast Chest CT
    Analysis of clearly visualized coronary segments on non-contrast chest CT using deep learning models, compared with CCTA reference standard.

Primary outcome measures

  • Accuracy of plaque composition prediction [Time frame: Baseline non-contrast chest CT to reference CCTA (within 30 days)]
  • Accuracy of ≥50% stenosis prediction [Time frame: Baseline non-contrast chest CT to reference CCTA (within 30 days)]
Secondary outcome measures (1)
  • Incidence of ≥50% stenosis in non-calcified segments [Time frame: Baseline non-contrast chest CT to CCTA (within 30 days)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 2 centers
  • The First Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou
  • The First Affiliated Hospital of Ningbo University — Ningbo

Identifiers

NCT: NCT07181512 · CAD-AI-2025-V1.0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗