Chest Pain CenterNCT07829536
Silent Deployment and Prospective Evaluation of Zhunxin Agent for Emergency Chest Pain Assessment
An observational study of Chest Pain Center and Chest Pain, run by Peking University Health Science Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain Center, Chest Pain
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 9 Sep 2026to 9 Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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:
Read more
- 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
- Conditions
- Chest Pain Center, Chest Pain
- Medical subject headings
- Chest Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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
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.
Measured: Up to 30 days after emergency department presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start9 Sep 2026 (estimated)
- Primary completion9 Sep 2030 (estimated)
- Study completion9 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest Pain CenterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Health Science Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yujie Xiao, Peking University Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829536
- Sponsor's protocol ID
- ZERO-2026-001
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Silent Deployment Study Evaluating the Clinical Performance of Zhunxin Agent for Emergency Chest Pain Assessment in ZERO-SL Study
- ClinicalTrials.gov ID
- NCT07829536
- Acronym / sponsor ID
- ZERO-2026-001
- Conditions
- Chest Pain Center, Chest Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Peking University Health Science CenterUniversity, hospital or other
- Study start
- 9 Sep 2026 (estimated)
- Primary completion
- 9 Sep 2030 (estimated)
- Study completion
- 9 Oct 2030 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants Correctly Classified by Zhunxin Agent Across the Prespecified Acute Chest Pain Diagnostic Categories
Time frame: 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.
2 secondary outcomes
Diagnostic Performance of Zhunxin Agent for High-Risk Acute Chest Pain Conditions Assessed by Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value, and AUROC
Time frame: 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
Time frame: Up to 30 days after emergency department presentation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain Center and Chest Pain, run by Peking University Health Science Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Correctly Classified by Zhunxin Agent Across the Prespecified Acute Chest Pain Diagnostic Categories (time frame: Up to 30 days after emergency department presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.