Silent Deployment and Prospective Evaluation of Zhunxin Agent for Emergency Chest Pain Assessment

NCT07829536 | Not Yet Recruiting

• 1 other identifier: ZERO-2026-001
• Study Type: observational
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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:

1. 1.How accurately can Zhunxin Agent identify serious causes of acute chest pain during routine emergency care?
2. 2.How well can Zhunxin Agent distinguish people at different levels of clinical risk?
3. 3.Receive usual emergency care according to local clinical practice
4. 4.Have routinely collected clinical data analyzed by Zhunxin Agent in the background
5. 5.Receive no additional treatment or clinical intervention based on the Agent's predictions

Conditions

Chest Pain; Chest Pain Center

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Correctly Classified by Zhunxin Agent Across the Prespecified Acute Chest Pain Diagnostic Categories

  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

Secondary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Health Science Center: lead

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Undergraduate

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 21, 2026
• Study Start: September 9, 2026
• Primary Completion (Estimated): September 9, 2030
• Study Completion (Estimated): October 9, 2030
• Last Updated: September 21, 2026

Record last verified: 2026-09