Skip to content

DigitHeart Echo Study

Cardiac Anatomical and Mechanical Properties Prediction From Electrocardiography (ECG) With Multi-Modal Representation Learning

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07558109
Acronym
DigitHeart-SHD
Enrollment
478
Registered
2026-04-30
Start date
2025-02-14
Completion date
2027-02-14
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Echocardiography, Electrocardiograph, Heart Disease

Brief summary

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.

Interventions

DIAGNOSTIC_TESTechocardiography

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.

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Model's Accuracy in predicting key echocardiographic parametersDay 1The 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.

Secondary

MeasureTime frameDescription
Model's Accuracy in predicting other key anatomical and mechanical propertiesDay 1Secondary 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

Countries

Hong Kong

Contacts

CONTACTChun Ka Dr Wong, Clinical Assistant Professor
wongeck@hku.hk+852-22553111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026