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Clinical Trials/NCT06092801
NCT06092801
Completed
Not Applicable

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

China National Center for Cardiovascular Diseases1 site in 1 country2,978 target enrollmentNovember 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
China National Center for Cardiovascular Diseases
Enrollment
2978
Locations
1
Primary Endpoint
Sensitivity of algorithm
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 20, 2023
End Date
April 9, 2025
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
China National Center for Cardiovascular Diseases
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Sensitivity of algorithm

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

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

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

  • Area under receiver operating curve (AUC)(At the end of enrollment (1 mouth))

Study Sites (1)

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