Clinical Trial

DigitHeart Echo Study

Study acronym: DigitHeart-SHD
Recruiting
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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.
Trial Details
NCT Number NCT07558109
Lead Sponsor The University of Hong Kong
Conditions Heart Disease, Electrocardiograph, Echocardiography
Enrollment 478 participants
Start Date 2025-02-14
Primary Completion 2027-02-14 (estimated)
Study Completion 2027-02-14 (estimated)
Updated on ClinicalTrials.gov 2026-04-30