Silent Deployment and Prospective Evaluation of Zhunxin Agent for Emergency Chest Pain Assessment
A Prospective Multicenter Silent Deployment Study Evaluating the Clinical Performance of Zhunxin Agent for Emergency Chest Pain Assessment in ZERO-SL Study
The goal of this prospective, multicenter observational study is to evaluate how well Zhunxin Agent, an artificial intelligence system for chest pain assessment, performs in real-world emergency department settings. The study will include people who receive routine care for acute chest pain at participating hospitals.
The main questions this study aims to answer are:
- How accurately can Zhunxin Agent identify serious causes of acute chest pain during routine emergency care?
- How well can Zhunxin Agent distinguish people at different levels of clinical risk?
Zhunxin Agent will run in silent mode using clinical information collected during routine care. Its predictions will not be shown to treating clinicians and will not affect clinical decisions, diagnostic tests, or treatment.
Researchers will compare the predictions made by Zhunxin Agent with the final clinical diagnoses established through routine medical care.
Participants will:
- Receive usual emergency care according to local clinical practice
- Have routinely collected clinical data analyzed by Zhunxin Agent in the background
- Receive no additional treatment or clinical intervention based on the Agent's predictions
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
The study population will consist of consecutive participants presenting with acute chest pain or symptoms suggestive of an acute chest pain condition to the emergency departments of participating hospitals during the prospective silent-deployment period. Participants will receive routine clinical care, while Zhunxin Agent will operate in the background without providing its predictions to treating clinicians.
Descripción
Inclusion Criteria:
- Participants aged 18 years or older.
- Participants presenting to a participating emergency department with acute chest pain, chest discomfort, or other symptoms that prompt clinical evaluation for an acute chest pain-related condition.
- Participants undergoing an electrocardiogram as part of routine clinical care during the index emergency department encounter.
- Participants with at least one electrocardiogram that can be processed by Zhunxin Agent during the index emergency department encounter.
- Participants with the routinely collected clinical information required for Zhunxin Agent to generate a valid prediction.
- Participants presenting to a participating study site during the prospective study period.
Exclusion Criteria:
- Participants whose emergency department presentation does not involve evaluation for acute chest pain.
- Participants without an electrocardiogram obtained during the index emergency department encounter.
- Participants for whom the electrocardiogram or other required input data are missing, corrupted, technically inaccessible, or otherwise unusable such that Zhunxin Agent cannot generate a valid prediction.
- Duplicate records corresponding to the same emergency department encounter.
- Participants whose clinical data cannot be used for research because of withdrawal of consent, refusal of data use where applicable, or other ethical, institutional, or regulatory restrictions.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants Correctly Classified by Zhunxin Agent Across the Prespecified Acute Chest Pain Diagnostic Categories
Periodo de tiempo: Up to 30 days after emergency department presentation
|
Diagnostic accuracy will be reported as the percentage of evaluable participants for whom the final diagnostic classification generated by Zhunxin Agent matches the final reference diagnosis. The prespecified diagnostic categories are unstable angina, non-ST-segment elevation myocardial infarction, ST-segment elevation myocardial infarction, aortic dissection, pulmonary embolism, and other causes of chest pain. The numerator will be the number of participants with a concordant Zhunxin Agent classification and reference diagnosis, and the denominator will be the total number of evaluable participants with both a valid Zhunxin Agent prediction and an available final reference diagnosis. |
Up to 30 days after emergency department presentation
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Diagnostic Performance of Zhunxin Agent for High-Risk Acute Chest Pain Conditions Assessed by Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, and AUROC
Periodo de tiempo: Up to 30 days after emergency department presentation
|
Diagnostic performance of Zhunxin Agent will be evaluated using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and the area under the receiver operating characteristic curve (AUROC), using the final reference diagnosis as the reference standard. Prespecified high-risk acute chest pain conditions include ST-segment elevation myocardial infarction, aortic dissection, and pulmonary embolism. Sensitivity will be calculated as the proportion of participants with a target condition who are correctly identified by Zhunxin Agent. Specificity will be calculated as the proportion of participants without the target condition who are correctly identified as negative. PPV will be calculated as the proportion of participants with a positive Zhunxin Agent prediction who have the target condition, and NPV as the proportion of participants with a negative prediction who do not have the target condition. AUROC will be calculated using the predicted probabili |
Up to 30 days after emergency department presentation
|
|
Percentage of Participants With a Confirmed High-Risk Acute Chest Pain Condition Within Each Zhunxin Agent Risk Category
Periodo de tiempo: Up to 30 days after emergency department presentation
|
The clinical risk stratification performance of Zhunxin Agent will be evaluated by calculating the percentage of participants with a confirmed high-risk acute chest pain condition within each prespecified risk category. Zhunxin Agent classifies participants into low-, intermediate-, and high-risk categories for ST-segment elevation myocardial infarction, aortic dissection, and pulmonary embolism using prespecified thresholds. For each target condition and risk category, the numerator will be the number of participants with the corresponding final reference diagnosis, and the denominator will be the total number of participants assigned to that risk category. The proportions will be reported separately for the low-, intermediate-, and high-risk categories. |
Up to 30 days after emergency department presentation
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- ZERO-2026-001
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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