Heart DiseaseDigitHeart-SHDNCT07558109
DigitHeart Echo Study
An observational study of Heart Disease and Electrocardiograph, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Disease, Electrocardiograph, Echocardiography
- What is being tested?
- echocardiography
- How many people
- 478 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 Feb 2025to 14 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients aged ≥ 18 years old who fulfill recruitment criteria will be recruited from Queen Mary Hospital and Tung Wah Hospital, Hong Kong.
Who may be able to join
- aged ≥ 18 years old
- planned to have echocardiography performed
- voluntarily agree to participate in the trial.
Who cannot join
- had echocardiography performed within 1 month
- pacemaker rhythm on ECG
- dextrocardia
- complex adult congenital heart disease
- ventricular assist device implantation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Medicine Queen Marry Hospital, Hong Kong
Hong Kong
Chun Ka Dr Wong, Clinical Assistant Professor, +852-22553111, wongeck@hku.hk
Chun Ka Dr Wong, Clinical Assistant Professor
About this study
Official title: Cardiac Anatomical and Mechanical Properties Prediction From Electrocardiography (ECG) With Multi-Modal Representation Learning
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.
- Conditions
- Heart Disease, Electrocardiograph, Echocardiography
- Being tested
- echocardiography
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone-Captured ECG Cohort | 12-lead ECG will be performed if it has not been performed within 6 month. Photo of the 12-lead ECG will be taken by research staff using DigitHeart-2 smartphone application. Prediction from DigitHeart-2/MERL-ECHO and other machine learning model(s) hosted by the investigator team for each of the target anatomical and mechanical properties will be recorded. 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 serve as gold standard for accuracy evaluation. Receives: Diagnostic Test: echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary 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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start14 Feb 2025
- Primary completion14 Feb 2027 (estimated)
- Study completion14 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 478 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wong Chun Ka, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558109
- Sponsor's protocol ID
- DigitHeart-SHD
- Other IDs
- HKWC/HKU IRB
- Acronym
- DigitHeart-SHD
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38768982
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Anatomical and Mechanical Properties Prediction From Electrocardiography (ECG) With Multi-Modal Representation Learning
- ClinicalTrials.gov ID
- NCT07558109
- Acronym / sponsor ID
- DigitHeart-SHD / DigitHeart-SHD
- Conditions
- Heart Disease, Electrocardiograph, Echocardiography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 478 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 14 Feb 2027 (estimated)
- Study completion
- 14 Feb 2027 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smartphone-Captured ECG Cohort | – | Diagnostic Test: echocardiography12-lead ECG will be performed if it has not been performed within 6 month. Photo of the 12-lead ECG will be taken by research staff using DigitHeart-2 smartphone application. Prediction from DigitHeart-2/MERL-ECHO and other machine learning model(s) hosted by the investigator team for each of the target anatomical and mechanical properties will be recorded. 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 serve as gold standard for accuracy evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged ≥ 18 years old who fulfill recruitment criteria will be recruited from Queen Mary Hospital and Tung Wah Hospital, Hong Kong.
Key inclusion criteria (3 listed)
- aged ≥ 18 years old
- planned to have echocardiography performed
- voluntarily agree to participate in the trial.
Key exclusion criteria (5 listed)
- had echocardiography performed within 1 month
- pacemaker rhythm on ECG
- dextrocardia
- complex adult congenital heart disease
- ventricular assist device implantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| echocardiographyParticipants 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. | Diagnostic test | Smartphone-Captured ECG Cohort |
Primary outcome
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.
1 secondary outcome
Model's Accuracy in predicting other key anatomical and mechanical properties
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Results publication: PubMed 38768982Wong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Disease and Electrocardiograph, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chun Ka Dr Wong, Clinical Assistant Professor (+852-22553111, wongeck@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Model's Accuracy in predicting key echocardiographic parameters (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07558109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.