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RECRUITING
NCT07181512

Deep Learning CAD Screening on Chest CT

Sponsor: Yifan Guo

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2025-09-01

Completion Date

2027-12-31

Last Updated

2026-02-17

Healthy Volunteers

Yes

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.

Locations (2)

The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China