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Recruiting NCT07558109

DigitHeart Echo Study

Observational Heart Disease Electrocardiograph Echocardiography

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: echocardiography.
Who it may be relevant to
Registry conditions: Heart Disease, Electrocardiograph, Echocardiography. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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.

Interventions

  • Diagnostic test echocardiography
    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 outcome measures

  • Model's Accuracy in predicting key echocardiographic parameters [Time frame: Day 1]
Secondary outcome measures (1)
  • Model's Accuracy in predicting other key anatomical and mechanical properties [Time frame: Day 1]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Hong Kong · 1 center
  • Department of Medicine Queen Marry Hospital, Hong Kong — Hong Kong

Publications

  • Wong CK, Lau YM, Lui HW, Chan WF, San WC, Zhou M, Cheng Y, Huang D, Lai WH, Lau YM, Siu CW. Automatic detection of cardiac conditions from photos of electrocardiogram captured by smartphones. Heart. 2024 Aug 14;110(17):1074-1082. doi: 10.1136/heartjnl-2023-323822. PMID 38768982

Identifiers

NCT: NCT07558109 · DigitHeart-SHD · HKWC/HKU IRB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗