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Diagnosis of HCM With AI-ECG

Diagnosis of Hypertrophic Cardiomyopathy With Artificial Intelligence-enhanced Electrocardiogram

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06287892
Enrollment
10000
Registered
2024-03-01
Start date
2024-01-01
Completion date
2024-12-31
Last updated
2024-03-06

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

Conditions

Hypertrophic Cardiomyopathy

Brief summary

The study aims to establish a diagnostic model of hypertrophic cardiomyopathy with artificial intelligence-enhanced electrocardiogram.

Interventions

None listed

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

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

Inclusion criteria

* Diagnosed with HCM

Exclusion criteria

* Patients with ventricular pacing

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis of HCM with AI-ECG1 year within the time frame of ECG data collectionFirst a diagnosis of HCM is made as the standard outcome according to 1) an International Classification of Diseases (ICD) code for HCM (ICD-9425.1, 425.11, 425.18, and ICD10 I42.1, I42.2); 2) reports from the echocardiographers. An AI-ECG algorithm will be used to make a diagnosis of HCM and compared with the standard outcome. The performance of the AI-ECG algorithm will be evaluated with metrics including AU-ROC, specificity, sensitivity and F1 value.

Countries

China

Contacts

Primary ContactYixiu Liang, MD
liang.yixiu@zs-hospital.sh.cn+8613764653847

Outcome results

None listed

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