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Completed

NCT Number: NCT06092801

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Sensitivity of algorithm

    Time frame: At the end of enrollment (1 mouth)

    Sensitivity of algorithm in predicting coronary artery disease assessed in test group

  2. Specificity of algorithm

    Time frame: At the end of enrollment (1 mouth)

    Sensitivity of algorithm in predicting coronary artery disease assessed in test group

Secondary outcomes

  1. Area under receiver operating curve (AUC)

    Time frame: At the end of enrollment (1 mouth)

    Area under receiver operating curve of algorithm in predicting coronary artery disease assessed in test group

Other outcomes

  1. Positive predictive value (PPV) of algorithm

    Time frame: At the end of enrollment (1 mouth)

    Positive predictive value (PPV) of algorithm in predicting coronary artery disease assessed in test group

  2. Negative predictive value (NPV)

    Time frame: At the end of enrollment (1 mouth)

    Negative predictive value (NPV) of algorithm in predicting coronary artery disease assessed in test group

  3. Diagnostic accuracy rate

    Time frame: At the end of enrollment (1 mouth)

    Diagnostic accuracy rate of algorithm in predicting coronary artery disease assessed in test group

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

Development and Validation of Artificial Intelligence Prediction Models Based on Multimodal, Non-contact Captured Information in Predicting Coronary Artery Disease

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 23, 2023
Registry last updated
Nov 28, 2025

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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