Actively Recruiting
Precision Diagnosis and Prognostic Prediction of Hypertrophic Cardiomyopathy Using Artificial Intelligence: A Multicenter Study
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-12-04
15000
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying hypertrophic cardiomyopathy (HCM), a condition where the heart muscle thickens, making it harder to pump blood. This study aims to improve diagnosis and prognosis of HCM by using artificial intelligence (AI) to analyze the standard 12-lead electrocardiogram (ECG). The project seeks to accurately classify different types of HCM and distinguish it from similar heart conditions like hypertensive heart disease and aortic stenosis, addressing challenges of late detection and inconsistent results across centers. The study uses AI models developed from a large historical dataset from multiple centers. These models analyze ECG signals to differentiate HCM from other heart conditions and healthy hearts. The approach combines deep learning with attention mechanisms and includes safeguards like version control, cloud-edge deployment, and offline replay evaluation to ensure reliable, real-world clinical use. The study involves three participant groups: those diagnosed with HCM, those with left ventricular hypertrophy from other causes, and healthy individuals without heart thickening. Participants will be adults aged 18 or older divided into these groups based on heart imaging and history. Researchers will collect and analyze ECG data to evaluate the AI model's diagnostic accuracy and generalizability over two years. The study does not involve treatment but focuses on observation and data collection. Participants' heart health will be assessed through echocardiography and ECG, with data securely managed to support model development and validation until the study ends in 2026.
CONDITIONS
Brief Title
AI-Enabled Diagnosis and Prognosis of Hypertrophic Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 63 18 years
- Adults diagnosed with hypertrophic cardiomyopathy according to the 2023 Chinese Guidelines for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy in Adults
- Adults with left ventricular wall thickness 63 13 mm on echocardiography (HCM phenocopy cohort)
- Adults with no history of cardiac disease and no evidence of myocardial hypertrophy on echocardiography (healthy-control cohort)
You will not qualify if you...
- Patients from whom analyzable ECG data cannot be obtained
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial assessment period
Participants undergo diagnostic assessments including 12-lead ECG and echocardiography to classify heart conditions.
1 to 2 visits depending on cohort assignment
Duration - Up to 2 years
Participants are monitored over time to collect data for AI model development and validation.
Periodic visits as scheduled by study sites
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
X
Xiaojie Xie, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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