Clinical trial NCT06695273: Using Retinal Photograph Based AI to Predict Incident Coronary Heart Disease
Official title: Using Retinal Photograph Based AI to Predict Incident Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Heart Disease (CHD)
Lead sponsor: Tsinghua University
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 1570
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: This is a randomized controlled trial (RCT) evaluating the effectiveness of an AI-based decision support tool in CHD risk prediction and decision making by physicians. Prospective cohort study participant cases will be randomly assigned to either guideline group (e.g., PCEs) or AI group after baseline assessment (clinical intuition):

There are three settings: (1) Clinical Intuition (baseline assessment) Physicians' make decision about prevention strategy initiation (e.g., statin initiation) without any external assistance. Assessment relies solely on the physician's clinical judgment and experience. (2) Guideline-Based Group (Guideline Group) Physicians use a PCE table to calculate the 10 year ASCVD risk. This approach aligns with current clinical guidelines to assist in decision-making. (3) AI-Assisted Group (AI Group) Physicians receive CHD probability estimates 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 CHD to a greater extent than standard clinical assessments, both compared to clinical intuition. The accuracy could be assessed by the extent of prevention initiation (e.g., prescribing statins) corresponding with actual CHD outcomes observed.

Secondary Objective To assess whether AI-guided decision support reduces the time required to complete CHD assessments and decision making.

Participants, Readers and Randomization:

Participants: Participants in prospective cohort studies, with 10-year follow up.

Readers: Physicians performing evaluations of CHD probability and make primary prevention recommendations.

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

Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* 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

Primary outcomes:
measure: Accuracy
timeFrame: Through study completion, an average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tsinghua University
name: Tien Yin Wong
role: PRINCIPAL_INVESTIGATOR
References: