AI-Enabled Diagnosis and Prognosis of Hypertrophic Cardiomyopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertrophic Cardiomyopathy (HCM) Left Ventricular Hypertrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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HCM

diagnosed with hypertrophic cardiomyopathy by echocardiography and cardiac magnetic resonance imaging

No interventions assigned to this group

phenocopy

patients with left-ventricular hypertrophy attributable to non-hypertrophic cardiomyopathy conditions

No interventions assigned to this group

normal control

healthy individuals without myocardial hypertrophy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Adults aged ≥ 18 years.
2. HCM cohort: Adults diagnosed with hypertrophic cardiomyopathy in accordance with the \*2023 Chinese Guidelines for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy in Adults\*.
3. HCM phenocopy cohort: Adults with an LV wall thickness ≥ 13 mm at any site on echocardiography.
4. Healthy-control cohort: Adults with no history of cardiac disease and no evidence of myocardial hypertrophy on echocardiography.