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

Recruiting

• Conditions: Chest Pain
• Interventions: Combination Product: Clinical evaluation, laboratory and cardiac imaging results, medication, surgery, and any hospitalization

• Registration Number: NCT06196307
• Lead Sponsor: Xiao-nan He

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.

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 Timeline

• Study Start: 2022-08-30
• Study First Submitted: 2023-10-27
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-07
• Last Update Submitted: 2024-01-07
• Study First Posted: 2024-01-09
• Last Update Posted: 2024-01-09
• Primary Completion: 2024-11-30
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 188

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No cardiovascular adverse events (MACE) occurred during the 1-month period	Clinical evaluation, laboratory and cardiac imaging results, medication, surgery, and any hospitalization	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.
Group of cardiovascular adverse events (MACE) occurring during 1 month	Clinical evaluation, laboratory and cardiac imaging results, medication, surgery, and any hospitalization	Cardiovascular adverse events occur, the rest of the same as in the previous group

Primary Outcome Measures

Name	Time	Method
Ecg findings of myocardial infarction, inverted T wave or soaring T wave, ST segment elevation, pathological Q wave, etc.	Baseline and week 12	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.
Myocardial injury marker level (cTn/CK-MB/MYO) level	Baseline and week 12	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.
Achieve HEART score levels 7-10 (high-risk patients) ratio.	Baseline and week 12	Myocardial infarction is often accompanied by severe chest pain symptoms, so a higher pain grade is considered as the clinical outcome
Incidence of cardiovascular events (CV death, all-cause death, fatal MI, nonfatal stroke).	Week 12	The usefulness of the experimental method was evaluated retrospectively by the incidence of cardiovascular events.

Trial Locations

Locations (1)

Xiaonan He; 🇨🇳 Beijing, Chaoyang, China