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Clinical Trials in China / NCT07449130
Recruiting Observational

AI Assisted Screening for VHD Using Routine Chest CT Scans

NCT07449130 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Observational
Started
2026-03-02
Last updated
2026-08-21

Condition(s) studied

Heart Valve Diseases

Study summary

This is a prospective, multicenter study designed to validate a deep learning model for screening valvular heart diseases using routine, non-contrast chest computed tomography (CT) scans.

The primary objective is to evaluate the model's diagnostic performance, with the sensitivity serving as the primary efficacy endpoint. Secondary endpoints will include other performance metrics such as area under the receiver operating characteristic curve (AUC), specificity, and accuracy, etc.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. Age ≥ 18 years. 2. Complete electronic health record. 3. Non-contrast chest CT performed between Nov 1, 2025 - Nov 1, 2026 in any medical context (including physical exam, outpatient, inpatient, or emergency). 4. AI-predicted moderate or severe valvular heart disease, or deemed to require clinical intervention, or selected negative cases from sampling verification. Exclusion Criteria: 1. Poor-quality non-contrast chest CT images. 2. Incomplete clinical records, involving severe deficiencies in critical diagnostic results, treatment records, imaging data, surgical records, medical history summaries, laboratory test results, or other essential medical information. 3. Presence of prosthetic valve implants, including aortic valves (mechanical valves, bioprosthetic valves), mitral valves (transcatheter edge-to-edge repair, bioprosthetic valves, mechanical valves, annuloplasty rings), tricuspid valves (TEER clipping, bioprosthetic valves, mechanical valves, annuloplasty rings), pulmonary valves (bioprosthetic valves), etc. 4. Abnormalities or conditions deemed by the investigator to warrant exclusion from the study enrollment.

Primary outcome measure(s)

  • Sensitivity — 1 year
    Sensitivity: Measures the proportion of patients with moderate-to-severe disease that the model correctly identifies.

Trial sites (3)

FacilityCityRegionStatus
Renmin Hospital of Wuhan University Wuhan Hubei Recruiting
Xinjiang Uygur Autonomous Region People's Hospital Ürümqi Xinjiang Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting

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Other trials for the same condition

Research on Optimal Diagnosis and Treatment of Cardiorenal Syndrome Recruiting
China Elderly Valve Disease Study III (China-DVD3 Study) Starting soon
Prognosis Prediction System of Patients With Cardiovascular and Cerebrovascular Diseases Based on Multi-omics Recruiting
Transpacific TAVR Registry Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07449130 on ClinicalTrials.gov ↗ ← All trials in China