Early Warning and Classification Model for Acute Non-traumatic Chest Pain

NCT06196307 | Recruiting DMC FDA Drug FDA Device

• 1 other identifier: F0213-62272327
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chest Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days after presenting to the emergency departments(ED)

Other Outcomes (1)

• Differences in accuracy in diagnosing acute non-traumatic chest pain using machine learning and intelligence-assisted models and existing scoring systems.

  Week 12

Study Arms (2)

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.

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

Combination Product: Clinical evaluation, laboratory and cardiac imaging results, medication, surgery, and any hospitalization

Interventions

Clinical evaluation, laboratory and cardiac imaging results, medication, surgery, and any hospitalization COMBINATION_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)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• traumatic chest pain
• systemic pain caused by malignant tumors or rheumatic diseases involving the chest
• Patients were lost to follow-up

Sponsors & Collaborators

• Xiao-nan He: lead

Study Sites (1)

Xiaonan He

Beijing, Chaoyang, 100029, China

RECRUITING

MeSH Terms

Conditions

Chest Pain

Interventions

Laboratories; Dosage Forms; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities; Health Facilities; Health Care Facilities Workforce and Services; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Central Study Contacts

Xiaonan / He, Professor

CONTACT

15001108399; hxndoctor@126.com

Haotian / Wu, Bachelor

CONTACT

13966123702; wuhaotian3702@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician of Emergency and Critical Care Center of Beijing Anzhen Hospital

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: January 9, 2024
• Study Start: August 30, 2022
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)