DigitHeart Echo Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe University of Hong Kong
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
aged ≥ 18 years old
planned to have echocardiography performed
voluntarily agree to participate in the trial.
Disqualifiers
had echocardiography performed within 1 month
pacemaker rhythm on ECG
dextrocardia
complex adult congenital heart disease
Trial population
Adult patients aged ≥ 18 years old who fulfill recruitment criteria will be recruited from Queen Mary Hospital and Tung Wah Hospital, Hong Kong.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
echocardiography
Diagnostic testParticipants 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.
Treatment groups
478 Participants
are divided into 1 treatment groupGroup A: Smartphone-Captured ECG Cohort1 intervention
Trial outcomes
Primary outcomes
1
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 1Secondary outcomes
1
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
Time frame
Day 1Sponsors and contacts
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Source ClinicalTrials.gov