AI-Enabled Diagnosis and Prognosis of Hypertrophic Cardiomyopathy
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hypertrophic Cardiomyopathy (HCM), Left Ventricular Hypertrophy. 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
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Precision Diagnosis and Prognostic Prediction of Hypertrophic Cardiomyopathy Using Artificial Intelligence: A Multicenter Study
Overview
By harnessing artificial intelligence to decode the 12-lead electrocardiogram, the project will enable precise ECG-based phenotyping of hypertrophic cardiomyopathy-accurately classifying septal, apical, and other morphologic subtypes-while simultaneously differentiating HCM from hypertensive heart disease, aortic stenosis, and other phenocopy disorders.
Detailed description
To overcome the twin bottlenecks of late detection and poor inter-centre reproducibility, the project leverages a large, multicentre historical cohort and anchors its pipeline on the 12-lead ECG-an inexpensive, ubiquitously available signal that can be captured in any department. Using deep-learning architectures augmented with attention mechanisms, we will develop (1) a discriminative model that separates HCM from phenocopies and normal hearts, and (2) an algorithmic framework that remains stable across devices and populations. Model governance will be embedded through version-controlled releases, cloud-edge deployment, and an "offline replay" evaluation loop, producing an end-to-end evidence chain that mirrors real-world clinical workflows.
Primary outcome measures
- model diagnostic performance [Time frame: year 2]
Secondary outcome measures (2)
- model diagnostic performance [Time frame: year 2]
- the model's generalizability [Time frame: year 2]
Eligibility criteria
Inclusion criteria
- Adults aged ≥ 18 years.
- HCM cohort: Adults diagnosed with hypertrophic cardiomyopathy in accordance with the \*2023 Chinese Guidelines for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy in Adults\*.
- HCM phenocopy cohort: Adults with an LV wall thickness ≥ 13 mm at any site on echocardiography.
- Healthy-control cohort: Adults with no history of cardiac disease and no evidence of myocardial hypertrophy on echocardiography.
Exclusion criteria
Patients from whom analyzable ECG data cannot be obtained.
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
China · 1 center
- Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT07263204 · 2024-1546