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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06287892
Other study ID # AI-ECG-HCM
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date December 31, 2024

Study information

Verified date March 2024
Source Shanghai Zhongshan Hospital
Contact Yixiu Liang, MD
Phone +8613764653847
Email liang.yixiu@zs-hospital.sh.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design


Locations

Country Name City State
China 180 Fenglin Road Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

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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