Clinical trial NCT06658600: Performance Evaluation of Artificial Intelligence Screening Model in Coronary Heart Disease Detection
Official title: Performance Evaluation of Artificial Intelligence Screening Model in Coronary Heart Disease Detection
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Heart Disease
Keywords: obstructive coronary heart disease
retinal images
artificial intelligence
Lead sponsor: Tsinghua University
Sponsor class: OTHER
Collaborators: name: Shanghai Sixth People's Hospital, Shanghai Jiao Tong University School of Medicine
name: Shanghai Health and Medical Center
First posted: 2024-10-26
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic Accuracy of Participants with Obstructive Coronary Heart Disease
timeFrame: Through study completion, an average of 1 week
Secondary outcomes:
measure: Time Consumed by Physician Readers to Provide the Diagnosis Impression of Obstructive Coronary Heart Disease.
timeFrame: Through study completion, an average of 1 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Tsinghua University
state: Beijing
city: Shanghai
country: China
facility: Shanghai Health and Medical Center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
Study officials:
affiliation: Tsinghua University
name: Tien Yin Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References: