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

Sponsor
China National Center for Cardiovascular Diseases (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06092801
Collaborator
(none)
998
13

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

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 Design

Study Type:
Observational
Anticipated Enrollment :
998 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Development and Validation of Artificial Intelligence Prediction Models Based on Multimodal, Non-contact Captured Information in Predicting Coronary Artery Disease
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Individuals suspected of coronary artery disease

Individuals suspected of coronary artery disease and referred for evaluation

Other: No intervention
No intervention

Outcome Measures

Primary Outcome Measures

  1. Sensitivity of algorithm [At the end of enrollment (1 mouth)]

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

  2. 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

  1. 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

Other Outcome Measures

  1. Positive predictive value (PPV) of algorithm [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) [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 [At the end of enrollment (1 mouth)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Suspected individuals referred to for coronary angiography, coronary computer tomography angiography, or functional stress tests.
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • China National Center for Cardiovascular Diseases

Investigators

  • Principal Investigator: Shen Lin, M.D., Ph.D., Fuwai Hospital, CAMS & PUMC

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier:
NCT06092801
Other Study ID Numbers:
  • 2022-GSP-QN-10
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023