Chest PainNCT06196307
Early Warning and Classification Model for Acute Non-traumatic Chest Pain
An observational study of Chest Pain, run by Xiao-nan He at 1 site in China.
Trial summary
Acute non-traumatic chest pain is one of the common causes of presentation in emergency patients, but the causes of acute non-traumatic chest pain are complex, the severity of the condition varies greatly, and the specificity of symptoms is not high. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain
- What is being tested?
- Clinical evaluation, laboratory and cardiac imaging results, medication, surgery, and any hospitalization
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2022to 30 Dec 2028
- How long will I take part?
- 1 Month
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population included patients admitted to the chest pain center of the pilot hospital from August 2022 to December 2027 with chest pain (including tingling, burning pain, pressure, tightness, heartburn and similar discomfort) as the main manifestations. Screening of patients with chest pain is intended from the following sources: 1. outpatients with chest pain; 2. outpatients with a history of cardiovascular disease; 3. patients from other departments of the hospital referred to the cardiology outpatient clinic due to acute chest pain.
Who may be able to join
- Age ≥ 18 years
- Symptom onset or worsening within 24 hours before presentation, with a chief complaint of acute chest pain meeting the broad definition of chest pain (2021 AHA)
- Presentation to the emergency department, with a clinical diagnosis consistent with non-traumatic chest pain
- Signed informed consent
Who cannot join
- traumatic chest pain
- systemic pain caused by malignant tumors or rheumatic diseases involving the chest
- Patients were lost to follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiaonan He
Beijing, Chaoyang, 100029
Xiaonan / HE, Professor, 15001108399, hxndoctor@126.com
About this study
Official title: A Prospective Study of Acute Nontraumatic Chest Pain - Warning and Classification
Acute non-traumatic chest pain is one of the common causes of presentation in emergency patients, but the causes of acute non-traumatic chest pain are complex, the severity of the condition varies greatly, and the specificity of symptoms is not high. Machine learning and intelligent auxiliary models can greatly shorten the time of clinical decision-making, and improve the accuracy of etiological diagnosis in patients with chest pain, reduce the rate of misdiagnosis and missed diagnosis, and provide a clear direction for further treatment.
Read the detailed description
Prospective observational studies used outpatient and follow-up information to construct an auxiliary early warning model of acute non-traumatic chest pain based on federated learning, and optimized the accuracy of early warning models through retrospective and prospective studies of large cohort data, and established an efficient and stable early warning and classification model for acute non-traumatic chest pain.
- Conditions
- Chest Pain
- Being tested
- Clinical evaluation, laboratory and cardiac imaging results, medication, surgery, and any hospitalization
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical evaluation, laboratory and cardiac imaging results, medication, surgery, and any hospitalizationCombination product
Examination： Electrocardiogram、 imaging examination、 X-ray, CTA, bedside echocardiography. Laboratory test results of patients, including complete blood count, D-dimer, myocardial injury markers, sST2, MPO, and other indicators. History of cardiovascular and pulmonary vascular drug therapy: Antithrombotic therapy (type, measurement) , Anticoagulation therapy (type, metering), Other drug treatments (type, measurement)
| Study group | Role | What they receive |
|---|---|---|
| No cardiovascular adverse and cerebrovascular events (MACCE) occurred during the 1-month period | No cardiovascular and cerebrovascular adverse events (MACCE)，which included cardiovascular death, all-cause mortality, nonfatal myocardial infarction, refractory angina, new onset heart failure and stroke. Follow-up visits are conducted by in-person or telephone and registration is carried out. Receives: Combination Product: Clinical evaluation, laboratory and cardiac imaging results, medication, surgery, and any hospitalization | |
| Group of major cardiovascular and cerebrovascular adverse events (MACCE) occurring during 1 month | Cardiovascular and cerebrovascular adverse events occur, the rest of the same as in the previous group Receives: Combination Product: Clinical evaluation, laboratory and cardiac imaging results, medication, surgery, and any hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
The primary outcome was a composite of adjudicated major adverse cardiovascular and cerebrovascular events (MACCE), which included cardiovascular death, all-cause mortality, nonfatal myocardial infarction, refractory angina, new onset heart failure and stroke.
Measured: 30 days after presenting to the emergency departments(ED)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start30 Aug 2022
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies 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)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Xiao-nan He
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiao-nan He, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196307
- Sponsor's protocol ID
- F0213-62272327
- Status last verified
- Feb 2026
- First submitted
- 27 Oct 2023
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Acute Nontraumatic Chest Pain - Warning and Classification
- ClinicalTrials.gov ID
- NCT06196307
- Acronym / sponsor ID
- F0213-62272327
- Conditions
- Chest Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Xiao-nan HeUniversity, hospital or other
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 9 Jan 2024 (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.
Acute non-traumatic chest pain is one of the common causes of presentation in emergency patients, but the causes of acute non-traumatic chest pain are complex, the severity of the condition varies greatly, and the specificity of symptoms is not high. Machine learning and intelligent auxiliary models can greatly shorten the time of clinical decision-making, and improve the accuracy of etiological diagnosis in patients with chest pain, reduce the rate of misdiagnosis and missed diagnosis, and provide a clear direction for further treatment.
Detailed description
Prospective observational studies used outpatient and follow-up information to construct an auxiliary early warning model of acute non-traumatic chest pain based on federated learning, and optimized the accuracy of early warning models through retrospective and prospective studies of large cohort data, and established an efficient and stable early warning and classification model for acute non-traumatic chest pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No cardiovascular adverse and cerebrovascular events (MACCE) occurred during the 1-month period | – | Combination Product: Clinical evaluation, laboratory and cardiac imaging results, medication, surgery, and any hospitalizationNo cardiovascular and cerebrovascular adverse events (MACCE)，which included cardiovascular death, all-cause mortality, nonfatal myocardial infarction, refractory angina, new onset heart failure and stroke. Follow-up visits are conducted by in-person or telephone and registration is carried out. |
| Group of major cardiovascular and cerebrovascular adverse events (MACCE) occurring during 1 month | – | Combination Product: Clinical evaluation, laboratory and cardiac imaging results, medication, surgery, and any hospitalizationCardiovascular and cerebrovascular adverse events occur, the rest of the same as in the previous group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population included patients admitted to the chest pain center of the pilot hospital from August 2022 to December 2027 with chest pain (including tingling, burning pain, pressure, tightness, heartburn and similar discomfort) as the main manifestations. Screening of patients with chest pain is intended from the following sources: 1. outpatients with chest pain; 2. outpatients with a history of cardiovascular disease; 3. patients from other departments of the hospital referred to the cardiology outpatient clinic due to acute chest pain.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Symptom onset or worsening within 24 hours before presentation, with a chief complaint of acute chest pain meeting the broad definition of chest pain (2021 AHA)
- Presentation to the emergency department, with a clinical diagnosis consistent with non-traumatic chest pain
- Signed informed consent
Key exclusion criteria (3 listed)
- traumatic chest pain
- systemic pain caused by malignant tumors or rheumatic diseases involving the chest
- Patients were lost to follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical evaluation, laboratory and cardiac imaging results, medication, surgery, and any hospitalizationExamination： Electrocardiogram、 imaging examination、 X-ray, CTA, bedside echocardiography. Laboratory test results of patients, including complete blood count, D-dimer, myocardial injury markers, sST2, MPO, and other indicators. History of cardiovascular and pulmonary vascular drug therapy: Antithrombotic therapy (type, measurement) , Anticoagulation therapy (type, metering), Other drug treatments (type, measurement) | Combination product | Group of major cardiovascular and cerebrovascular adverse events (MACCE) occurring during 1 month, No cardiovascular adverse and cerebrovascular events (MACCE) occurred during the 1-month period |
Primary outcome
Adverse events
Time frame: 30 days after presenting to the emergency departments(ED)
The primary outcome was a composite of adjudicated major adverse cardiovascular and cerebrovascular events (MACCE), which included cardiovascular death, all-cause mortality, nonfatal myocardial infarction, refractory angina, new onset heart failure and stroke.
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 5 Feb 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain, run by Xiao-nan He at 1 site in China.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Xiaonan / He, Professor (15001108399, hxndoctor@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 30 days after presenting to the emergency departments(ED)). 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 5 Feb 2026.