DigitHeart Echo Study

The University of Hong Kong478 enrolled

Overview

Eligible patients will be interviewed by research staff to explain the trial design and rationale. Written informed consent will be obtained from patients who voluntarily agree to participate. Demographics and medical history will be obtained. A 12-lead ECG will be performed; it has not been performed within 6 months. A photo of the 12-lead ECG will be taken by research staff using the DigitHeart-2 smartphone application. Predictions from DigitHeart-2/MERL-ECHO and other machine learning models hosted by the investigator team for each of the target anatomical and mechanical properties will be recorded. The cardiologist in charge of the patient, who is blinded to the prediction results from DigitHeart-2/MERL-ECHO, will perform echocardiography according to American Society of Echocardiography guidelines, which will serve as the gold standard for accuracy evaluation.

Study Type

OBSERVATIONAL

Enrollment

478

Conditions

Heart Disease Electrocardiograph Echocardiography

Interventions

Participants will undergo an echocardiography to determine their cardiac structure, heart function and valve function. The gold-standard measurement from the echocardiography text report will be the reference for validating the multi-modal prediction.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * aged ≥ 18 years old * planned to have echocardiography performed * voluntarily agree to participate in the trial. Exclusion Criteria: * had echocardiography performed within 1 month * pacemaker rhythm on ECG * dextrocardia * complex adult congenital heart disease * ventricular assist device implantation.

Outcomes

Primary Outcomes

Model's Accuracy in predicting key echocardiographic parameters

The primary outcome is the accuracy of the integrated DigitHeart- 2/MERL-ECHO system in predicting key echocardiographic parameters from smartphone-captured ECG images, as measured by AUROC and F1 scores.

Time frame: Day 1

Secondary Outcomes

Model's Accuracy in predicting other key anatomical and mechanical properties

Secondary outcomes include accuracy of predicting other anatomical and mechanical properties including: * Impaired left ventricular systolic function * Dilated right ventricle * Impaired right ventricular function * Moderate to severe aortic stenosis * Moderate to severe aortic regurgitation * Moderate to severe mitral stenosis * Moderate to severe mitral regurgitation * Moderate to severe tricuspid regurgitation