Prediction of Coronary Artery Disease Based on Multimodal, Non-contact Information With Artificial Intelligence

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT06092801
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

The goal of this observational study are 1) to assess the effectiveness of modalities and/or their combination of multimodal non-contact information in predicting coronary artery disease; 2) to prospectively validate the performance of the developed artificial Intelligence models in predicting coronary artery disease.

Detailed Description

This observational study aims to assess the effectiveness and potential mechanism of modalities of non-contact captured bio-physiological information, including facial RGB information, infrared thermography temperature information, gait information, and wearable device information, individually and/or in combination, in predicting coronary artery disease (CAD) with artificial intelligence technology.

Individuals suspected of CAD and referred for evaluation will be invited to participate in the current study for analyzing the non-contact information and association with underlying CAD status, in order to establish the most efficient artificial Intelligence modeling strategy, and prospectively validate the predictive performance of the developed artificial Intelligence models for CAD prediction.

Study Timeline

• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-10-16
• Study First Posted: 2023-10-23
• Study Start: 2023-11-20
• Primary Completion: 2024-10-28
• Study Completion: 2024-10-28
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-12
• Last Update Posted: 2025-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 998

Inclusion Criteria

• Suspected individuals referred to for coronary angiography or coronary computer tomography angiography.

Exclusion Criteria

• Prior percutaneous coronary intervention (PCI)
• Prior coronary artery bypass graft (CABG)
• Undergoing confirmatory coronary evaluation as pre-operation routines for other cardiac diseases
• With artificial body alteration (e.g. cosmetic surgery, facial trauma, or make-up) that may affect the non-contact information of study interest
• Age less than 18 years old
• Other circumstances that prevent participants from cooperating with the study process
• Decline to consent for study participation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of algorithm	At the end of enrollment (1 mouth)	Sensitivity of algorithm in predicting coronary artery disease assessed in test group
Specificity of algorithm	At the end of enrollment (1 mouth)	Sensitivity of algorithm in predicting coronary artery disease assessed in test group

Secondary Outcome Measures

Name	Time	Method
Area under receiver operating curve (AUC)	At the end of enrollment (1 mouth)	Area under receiver operating curve of algorithm in predicting coronary artery disease assessed in test group

Trial Locations

Locations (1)

Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China