A Prospective Multicenter Silent Deployment Study Evaluating the Clinical Performance of Zhunxin Agent for Emergency Chest Pain Assessment in ZERO-SL Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10,000
- 主要终点
- Percentage of Participants Correctly Classified by Zhunxin Agent Across the Prespecified Acute Chest Pain Diagnostic Categories
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Percentage of Participants Correctly Classified by Zhunxin Agent Across the Prespecified Acute Chest Pain Diagnostic Categories
时间窗: 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.
次要结局
- Diagnostic Performance of Zhunxin Agent for High-Risk Acute Chest Pain Conditions Assessed by Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, and AUROC(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(Up to 30 days after emergency department presentation)
研究者
Yujie Xiao
Undergraduate
Peking University Health Science Center