NCT07449130 AI Assisted Screening for VHD Using Routine Chest CT Scans
| NCT ID | NCT07449130 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Heart Valve Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2026-03-02 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2026-03-02 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07449130 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Valve Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07449130 currently recruiting?
Yes, NCT07449130 is actively recruiting participants. Contact the research team at wangjianan111@zju.edu.cn for enrollment information.
Where is the NCT07449130 trial being conducted?
This trial is being conducted at Wuhan, China, Ürümqi, China, Hangzhou, China.
Who is sponsoring the NCT07449130 clinical trial?
NCT07449130 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 3,000 participants.