Using Retinal Photograph Based AI to Predict Incident Coronary Heart Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorTsinghua University

About this trial

To determine whether an integrated retinal AI decision support can improve predictive accuracy of coronary heart disease (CHD), the investigators are conducting a randomized controlled study of AI guided prediction of CHD compared to clinical prediction by physicians (e.g., usingPCEs), both using clinical intuition as baseline.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Individuals without uncontrolled vascular risk factors

Age range: 40-75 years old

Can accept and cooperate with the examination and potential follow-up work after being selected for clinical trials

Disqualifiers

Severe lung disease and cancer or surgery patients

Statin user or pre-existing cardiovascular disease

Individuals with severe liver and kidney dysfunction and electrolyte imbalance

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI-derived probability of coronary heart disease.

    Diagnostic test

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

  • PCEs derived ASCVD risk

    Diagnostic test

    Physicians use a PCEs to calculate the probability of 10 year ASCVD risk. This approach aligns with current clinical guidelines to assist in decision-making.

Treatment groups

1,570 Participants
are divided into 2 treatment groups
Group A: AI-Assisted Group (AI Group)Experimental treatment 1 intervention
Group B: Guideline-Based Group (Guideline Group)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Accuracy

To evaluate whether AI-guided decision support could improves diagnostic accuracy of CHD to a greater extent than standard clinical assessments, both compared to clinical intuition. The accuracy could be assessed by the degree to which prevention initiation (e.g., prescribing statins) align with actual CHD outcomes observed.

Time frame
Through study completion, an average of 1 week

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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