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

Chest Pain Clinical Trial

Official title:

A Prospective Study of Acute Nontraumatic Chest Pain - Warning and Classification

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06196307
• Other study ID #: F0213-62272327
• Status: Recruiting
• Start date: August 30, 2022
• Est. completion date: January 30, 2025

Study information

• Verified date: January 2024
• Source: Beijing Anzhen Hospital
• Contact: Xiaonan He, Professor
• Phone: 15001108399
• Email: hxndoctor[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: January 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chest Pain

Intervention

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)

Locations

Country	Name	City	State
China	Xiaonan He	Beijing	Chaoyang

Sponsors (1)

Lead Sponsor	Collaborator
Xiao-nan He

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	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