Hypertrophic Cardiomyopathy Clinical Trial
Official title:
Diagnosis of Hypertrophic Cardiomyopathy With Artificial Intelligence-enhanced Electrocardiogram
The study aims to establish a diagnostic model of hypertrophic cardiomyopathy with artificial intelligence-enhanced electrocardiogram.
| Status | Recruiting |
| Enrollment | 10000 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Diagnosed with HCM Exclusion Criteria: - Patients with ventricular pacing |
| Country | Name | City | State |
|---|---|---|---|
| China | 180 Fenglin Road | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai Zhongshan Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diagnosis of HCM with AI-ECG | First 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. |
1 year within the time frame of ECG data collection |
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