Not_yet_recruitingNCT07536932

A Multicenter Prospective Study to Develop and Validate an Artificial Intelligence-Based Electrocardiogram Model for the Diagnosis of Acute Type A Aortic Dissection in Patients Presenting With Chest Pain

Sponsor: Shanghai Zhongshan Hospital

Trial Details

ConditionAortic Dissection Type A, Chest Pain
StatusNot_yet_recruiting
Participants10,000
Est. Completion1 Dec 2026
Last Updated17 Apr 2026

Primary Outcome

Diagnostic performance of the AI-based electrocardiogram model for acute type A aortic dissection

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: * Male or female emergency department patients aged 18-80 years; * Clear presentation of chest pain or related chest/back pain; * Completion of standard 12-lead electrocardiography (ECG) within 24 hours after onset of chest pain; * ECG signal quality meeting the following criteria: QRS amplitude ≥ 0.1 mV and noise proportion \< 20%; * Availability of subsequent diagnostic workup confirming whether the patient had acute type A aortic dissection (TAAD) or another definitive diagnosis. Exclusion Criteria: * Poor-quality ECG recordings, defined as missing leads in ≥ 3 leads or severe baseline instability; * Indeterminate final diagnosis; * History of prior surgery involving the aortic valve, aortic root, or ascending aorta.

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