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

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.

Study Overview

• Status: Recruiting
• Conditions: Chest Pain
• Intervention / Treatment: Combination product: Clinical evaluation, laboratory and cardiac imaging results, medication, surgery, and any hospitalization

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 Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Xiaonan / HE, Professor; Phone Number: 15001108399; Email: hxndoctor@126.com
• Study Contact Backup: Name: Haotian / Wu, Bachelor; Phone Number: 13966123702; Email: wuhaotian3702@163.com

Study Locations

• China
  • Chaoyang
    • Beijing, Chaoyang, China, 100029
      • Recruiting
      • Xiaonan He
      • Contact: Xiaonan / HE, Professor; Phone Number: 15001108399; Email: hxndoctor@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. 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)
3. Presentation to the emergency department, with a clinical diagnosis consistent with non-traumatic chest pain
4. Signed informed consent

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; 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; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in accuracy in diagnosing acute non-traumatic chest pain using machine learning and intelligence-assisted models and existing scoring systems.	Cross-disciplinary testing	Week 12

Collaborators and Investigators

• Sponsor: Xiao-nan He

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2022
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: January 7, 2024
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chest Pain; Pharmaceutical Preparations; Investigative Techniques; Health Care Facilities Workforce and Services; Technology, Pharmaceutical; Non-Medical Public and Private Facilities; Health Facilities; Dosage Forms; Surgical Procedures, Operative; Laboratories
• Other Study ID Numbers: F0213-62272327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes