Performance Evaluation of Artificial Intelligence Screening Model in Coronary Heart Disease Detection (DeepCHD)

April 7, 2025 updated by: Tien Yin Wong, Tsinghua University
To determine whether an integrated AI decision support can save time and improve accuracy of assessment of obstructive coronary heart disease (CHD), the investigators are conducting a randomized controlled study of AI guided measurements of obstructive CHD probability compared to clinical assessment in preliminary evaluations by physicians.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized controlled trial (RCT) evaluating the effectiveness of an AI-based decision support tool in the preliminary assessment of obstructive CHD by physicians. Retrospectively collected medical records of participants with chest pain or dyspnea will be randomly assigned to either guideline group or AI group after baseline assessment:

There are three settings:

  1. Clinical Intuition (baseline assessment) Physicians assess obstructive CHD probability without any external assistance. Assessment relies solely on the physician's clinical judgment and experience.

  2. Guideline-Based Group (Guideline Group) Physicians use a RF-CL table (risk factor weighted clinical likelihood table) to calculate the probability of obstructive CHD.

    This approach aligns with current clinical guidelines to assist in decision-making.

  3. AI-Assisted Group (AI Group) Physicians receive CHD probability estimates and diagnostic recommendations from an AI model based on retinal photographs.

The AI tool provides individualized obstructive CHD probabilities, leveraging retinal biomarkers associated with cardiovascular risk.

Primary Objective To evaluate whether AI-guided decision support could improves diagnostic accuracy of obstructive CHD to a greater extent than standard clinical assessments, both compared to clinical intuition.

Secondary Objective To assess whether AI-guided decision support reduces the time required to complete preliminary assessments of obstructive CHD.

Participants, Readers and Randomization Participants: Case records of participants with chest pain or dyspnea, all underwent CT coronary angiography or invasive coronary angiography.

Readers: Physicians performing preliminary evaluations of obstructive CHD patients.

Randomization: Participants and readers will be randomized into one of the groups (RF-CL or AI) after clinical assessment at baseline using block randomization to ensure balanced group sizes.

Study Type

Interventional

Enrollment (Estimated)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100084
        • Tsinghua University
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Shanghai Health and Medical Center
      • Shanghai, Shanghai, China, 200000
        • Shanghai Sixth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Individuals with symptoms of coronary heart disease
  • Age range: 18-75 years old
  • Can accept and cooperate with the examination and potential follow-up work after being selected for clinical trials

Exclusion criteria:

  • Severe hypertension (>180/110mmHg)
  • Complex arrhythmia (atrial fibrillation, atrial flutter, frequent premature beats)
  • Severe lung disease and chest malformation or surgery patients
  • Acute myocardial infarction occurring less than 3 months ago
  • Individuals with severe liver and kidney dysfunction and electrolyte imbalance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Guideline-Based Group (Guideline Group)

Physicians use a RF-CL table (risk factor weighted clinical likelihood table) to calculate the probability of obstructive CHD.

This approach aligns with current clinical guidelines to assist in decision-making.
Other: Physician readers will be assisted with RF-CL table to calculate the probability of obstructive coronary heart disease
Physicians use a RF-CL table (risk factor weighted clinical likelihood table) to calculate the probability of obstructive CHD.
Experimental: AI-Assisted Group (AI Group)

Physicians receive CHD probability estimates and diagnostic recommendations from an AI model based on retinal photographs.

The AI tool provides individualized obstructive CHD probabilities, leveraging retinal biomarkers associated with cardiovascular risk.
Other: Physician readers will be assisted with AI-derived probability and diagnosis of obstructive coronary heart disease
Physician readers will be assisted with AI-derived probability and diagnosis of obstructive coronary heart disease. The AI tool provides individualized obstructive CHD probabilities and diagnosis, leveraging retinal biomarkers associated with cardiovascular risk.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy of Participants with Obstructive Coronary Heart Disease
Time Frame: Through study completion, an average of 1 week

Whether AI-guided decision support improves the diagnostic accuracy of obstructive coronary heart disease (CHD) to a greater extent than standard clinical assessments (RF-CL), both compared to clinical intuition.

All participants of the case records had underwent CT angiography or invasive angiography. The diagnostic accuracy, sensitivity and specificity will be compared across groups.
Through study completion, an average of 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Consumed by Physician Readers to Provide the Diagnosis Impression of Obstructive Coronary Heart Disease.
Time Frame: Through study completion, an average of 1 week
The time consumed by physician readers will be recorded by an algorithm implemented on the website for reading.
Through study completion, an average of 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tsinghua University

Collaborators

Shanghai Sixth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Health and Medical Center

Investigators

  • Principal Investigator: Tien Yin Wong, PhD, Tsinghua University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2025

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DeepCHD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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