Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Yan'an Affiliated Hospital of Kunming Medical University | OTHER |
| Taian City Central Hospital | OTHER |
| Mianyang Central Hospital | OTHER |
| Guangdong Provincial People's Hospital |
Not provided
Not provided
Not provided
Not provided
The goal of this prospective multicenter observational study is to learn whether an artificial intelligence model based on electrocardiograms (ECGs) can help diagnose acute type A aortic dissection (TAAD) in adults who come to the emergency department with chest pain or related symptoms. The main question it aims to answer is:
Can the AI-ECG model accurately distinguish TAAD from other causes of chest pain in a real-world emergency setting? Researchers will compare the AI model's ECG-based predictions with the final diagnosis confirmed by computed tomographic angiography (CTA), which is the reference standard. Participants will undergo routine emergency ECG testing and subsequent diagnostic evaluation as part of standard care. Clinical and ECG data will be collected from five tertiary hospitals, and the model's diagnostic performance will be assessed across centers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Type A Aortic Dissection (TAAD) | Participants presenting with chest pain or related symptoms who are ultimately diagnosed with acute type A aortic dissection based on computed tomographic angiography (CTA) or other definitive diagnostic modalities. All participants undergo electrocardiogram (ECG) acquisition and standard clinical evaluation in the emergency setting, and their data are used to assess the diagnostic performance of the artificial intelligence-based ECG model. | ||
| Non-TAAD Chest Pain | Participants presenting with chest pain or related symptoms who are determined not to have acute type A aortic dissection after complete diagnostic evaluation. Final diagnoses may include other cardiovascular or non-cardiovascular causes of chest pain. All participants undergo electrocardiogram (ECG) acquisition and standard clinical evaluation in the emergency setting, and their data are used to assess the diagnostic performance of the artificial intelligence-based ECG model. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of the AI-based electrocardiogram model for acute type A aortic dissection | Diagnostic performance of the artificial intelligence model based on electrocardiograms for identifying acute type A aortic dissection among patients presenting with chest pain or related symptoms, using CTA-confirmed final diagnosis as the reference standard. Primary performance will be summarized by the area under the receiver operating characteristic curve (AUROC). | From emergency department presentation to completion of CTA and final diagnostic confirmation during the index visit, up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of the AI-based electrocardiogram model for acute type A aortic dissection | Sensitivity of the artificial intelligence model based on electrocardiograms for identifying acute type A aortic dissection among patients presenting with chest pain or related symptoms, using CTA-confirmed final diagnosis as the reference standard. | From emergency department presentation to completion of CTA and final diagnostic confirmation during the index visit, up to 24 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Adult male and female emergency department patients aged 18 to 80 years who present with clear chest pain or related chest/back pain symptoms at five tertiary hospitals, undergo standard 12-lead electrocardiography within 24 hours of symptom onset, and subsequently receive definitive diagnostic evaluation confirming acute type A aortic dissection or another final diagnosis.
Not provided
| ID | Term |
|---|---|
| D002637 | Chest Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
| Specificity of the AI-based electrocardiogram model for acute type A aortic dissection | Specificity of the artificial intelligence model based on electrocardiograms for correctly identifying participants who do not have acute type A aortic dissection, using CTA-confirmed final diagnosis as the reference standard. | From emergency department presentation to completion of CTA and final diagnostic confirmation during the index visit, up to 24 hours |
| Positive predictive value of the AI-based electrocardiogram model for acute type A aortic dissection | Positive predictive value of the artificial intelligence model based on electrocardiograms for acute type A aortic dissection among participants classified as positive by the model, using CTA-confirmed final diagnosis as the reference standard. | From emergency department presentation to completion of CTA and final diagnostic confirmation during the index visit, up to 24 hours |
| Negative predictive value of the AI-based electrocardiogram model for acute type A aortic dissection | Negative predictive value of the artificial intelligence model based on electrocardiograms for acute type A aortic dissection among participants classified as negative by the model, using CTA-confirmed final diagnosis as the reference standard. | From emergency department presentation to completion of CTA and final diagnostic confirmation during the index visit, up to 24 hours |
| Diagnostic time from emergency department presentation to AI model output | Elapsed time from emergency department presentation to generation of the artificial intelligence model output after electrocardiogram acquisition. | At the index visit, up to 24 hours |
| Diagnostic time reduction associated with the AI-based electrocardiogram workflow compared with standard care | Difference in diagnostic time between the AI-based electrocardiogram workflow and the conventional diagnostic process. This outcome will be calculated as the time from emergency department presentation to final diagnostic confirmation under standard care minus the time from emergency department presentation to AI model output. | At the index visit, up to 24 hours |