AI-assisted screening for heart valve disease using routine non-contrast chest CT

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter effort to validate a deep learning model that analyzes routine non-contrast chest CT images from adults seen in physical exams and outpatient or inpatient settings. The AI analyzes scans in real time and flags cases predicted to have moderate-to-severe valvular heart disease. Participants flagged by the AI will receive an immediate confirmatory echocardiogram, which serves as the diagnostic reference standard. The primary performance endpoint is sensitivity, with secondary endpoints including AUC, specificity, and accuracy, and results will be analyzed with 95% confidence intervals over an estimated 12-month enrollment period.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Jian'an Wang, MD
• Email: wangjianan111@zju.edu.cn
• Phone: +86-571-8778-4808

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.