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): 188

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 2022 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. older than 18 years old;
2. provided written informed consent;
3. Outpatient visits in the pilot hospitals from June 2022 to December 2022

Exclusion Criteria:

1. did not provide written informed consent and were unwilling to be followed up;
2. traumatic chest pain;
3. systemic pain caused by malignant tumors or rheumatic diseases involving the chest;
4. transferred patients;
5. sudden death or death during hospital treatment;
6. women who are known to be pregnant or lactating;
7. have participated in other clinical trials within 3 months before enrolling in this trial or are currently participating in other clinical trials The lender;
8. According to the investigator's judgment, the patient was unable to complete the study or comply with the requirements of the study;
9. 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 events (MACE) occurred during the 1-month period; No cardiovascular adverse events (MACE)，which include all-cause death, myocardial infarction, emergency revascularization, cardiogenic shock, cardiac arrest/ventricular fibrillation, stroke, and so on. 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. History of cardiovascular and pulmonary vascular drug therapy: Antithrombotic therapy (type, measurement) , Anticoagulation therapy (type, metering), Other drug treatments (type, measurement)
Group of cardiovascular adverse events (MACE) occurring during 1 month; Cardiovascular 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. 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
Ecg findings of myocardial infarction, inverted T wave or soaring T wave, ST segment elevation, pathological Q wave, etc.	Whether the patient has obvious abnormal ECG findings, such as myocardial infarction, conduction block. After coronary artery occlusion, three types of patterns of ischemia, injury and necrosis may appear successively on the electrocardiogram (ECG) over time. These changes of ECG patterns had obvious regional characteristics.	Baseline and week 12
Myocardial injury marker level (cTn/CK-MB/MYO) level	Myocardial injury markers refer to the proteins and/or enzymes that are released into peripheral blood and detected when myocardial injury occurs. The detection of these substances may be helpful for clinical diagnosis, disease monitoring and risk stratification of acute myocardial infarction and other diseases associated with myocardial injury.	Baseline and week 12
Achieve HEART score levels 7-10 (high-risk patients) ratio.	Myocardial infarction is often accompanied by severe chest pain symptoms, so a higher pain grade is considered as the clinical outcome	Baseline and week 12
Incidence of cardiovascular events (CV death, all-cause death, fatal MI, nonfatal stroke).	The usefulness of the experimental method was evaluated retrospectively by the incidence of cardiovascular events.	Week 12

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): November 30, 2024
• Study Completion (Estimated): January 30, 2025

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): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 7, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chest Pain
• 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