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AI-Enabled Diagnosis and Prognosis of Hypertrophic Cardiomyopathy

Precision Diagnosis and Prognostic Prediction of Hypertrophic Cardiomyopathy Using Artificial Intelligence: A Multicenter Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07263204
Enrollment
15000
Registered
2025-12-04
Start date
2025-01-01
Completion date
2026-12-31
Last updated
2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Cardiomyopathy (HCM), Left Ventricular Hypertrophy

Brief summary

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.

Interventions

None listed

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Exclusion criteria

Patients from whom analyzable ECG data cannot be obtained.

Design outcomes

Primary

MeasureTime frameDescription
model diagnostic performanceyear 2Model performance was evaluated using calculated metrics including accuracy, sensitivity, specificity, and the area under the ROC curve (AUC).

Secondary

MeasureTime frameDescription
model diagnostic performanceyear 2The accuracy rate of the model's phenotype-specific classification for patients with different patterns of myocardial hypertrophy
the model's generalizabilityyear 2The model's diagnostic performance on the external, multicentre validation cohort, including overall accuracy, sensitivity, specificity, and area under the ROC curve (AUC).

Countries

China

Contacts

Primary ContactXiaojie Xie, MD, PhD
xiexj@zju.edu.cn(+86)0571-87784700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026