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NCT Number: NCT07558109

DigitHeart Echo Study

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.

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Key information

Conditions

Heart Disease Cardiovascular Diseases Echocardiography Electrocardiograph Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Medicine Queen Marry Hospital, Hong Kong

Hong Kong

Location status: Recruiting

Location contact

Chun Ka Dr Wong, Clinical Assistant Professor

CONTACT

[email protected]

+852-22553111

Chun Ka Dr Wong, Clinical Assistant Professor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Echocardiography

Diagnostic Test

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.

Primary outcomes

  1. Model's Accuracy in predicting key echocardiographic parameters

    Time frame: Day 1

    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.

Secondary outcomes

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

    Time frame: Day 1

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Chun Ka Dr Wong, Clinical Assistant Professor

CONTACT

[email protected]

+852-22553111

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Acronym: DigitHeart-SHD

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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