Prospective Multicenter Study for Early Evaluation of Acute Chest Pain

Study Overview
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Brief Summary
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In this study, clinical database and blood sample bank of acute chest pain (ACP) will be established at chest pain center of multi-center hospital. To explore new biomarkers and screen clinical indicators with effective risk stratification and prognostic evaluation for ACP through proteomics technology and statistics methods. Risk stratification and short-term and long-term prognostic evaluation models for high-risk ACP will be established using large data analysis.

Detailed Description
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In this study, acute chest pain (ACP) patients will be selected from chest pain center of nine large tertiary hospitals in China from November 1, 2019 to October 31, 2021. All the selected patients will sign the informed consent. Patients' characteristics, the first vital signs at the time of consultation, the first arterial blood gas, complete blood count, coagulation markers, blood biochemical results and myocardial injury markers, imaging examinations and electrocardiogram will be collected within 30 minutes at admission. Meanwhile, whole blood and plasma samples will be collected and stored in - 80 ℃ refrigerator. After diagnosis according to the gold standard examination or related guidelines, patients will be admitted to different department for standard treatment. Medication, surgical procedures and complications will be recorded carefully. Plasma and whole blood will be used to detect proteomics and/or genomics biomarkers associated with early evaluation of ACP. Screening early evaluation indicators using novel protein biomarkers and easy-to-obtain clinical indicators, and establishing evaluation models for high-risk ACP by data analysis methods. Area under the receiver operating characteristic curves (AUROC), net reclassification improvement (NRI), integrated discrimination improvement (IDI) and decision curve analysis (DCA) will be used to evaluate the prediction ability of the model.

Official Title
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Prospective Multicenter Study for Early Evaluation of Acute Chest Pain

Conditions
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Chest Pain, Acute Aortic Dissection, Pulmonary Embolism, Acute Myocardial Infarction Type 1, Acute Coronary Syndrome

Intervention / Treatment
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* Diagnostic Test: Coronary angiography
* Diagnostic Test: CT angiography of aorta
* Diagnostic Test: CT angiography of pulmonary arteries.
* Diagnostic Test: Electrocardiogram
* Diagnostic Test: Cardiac Troponin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 18-90 years old; The time from onset of symptoms to emergency room is less than 24 hours. Exclusion Criteria: Patients complicate with end-stage neoplastic diseases; Pregnant women; Patients re-visit during the selection period; Patients refuse to participate in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute chest pain<br>The population in this study are characterized by acute chest pain as the first symptom for consultation within 24 hours. | Diagnostic Test: Coronary angiography<br>* Acute chest pain patients, suspected acute coronary syndrome, are diagnosed by coronary angiography.<br>Diagnostic Test: CT angiography of aorta<br>* Acute chest pain patients, suspected acute aortic dissection, are diagnosed by gold standard of CTA.<br>* Other names: CTA;Diagnostic Test: CT angiography of pulmonary arteries.<br>* Acute chest pain patients, suspected acute pulmonary embolism, are diagnosed by gold standard of CTA.<br>* Other names: CTA;Diagnostic Test: Electrocardiogram<br>* All patients with acute chest pain will subject to ECG examination within 10 minutes of admission, which can quickly screen ST-segment elevation myocardial infarction.<br>* Other names: ECG;Diagnostic Test: Cardiac Troponin<br>* Dynamic changes of cardiac troponin I and/or T will be used in the diagnosis of acute myocardial infarction<br>* Other names: Biomarkers of myocardial injury;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of participants with all-cause death | Patients die of all causes during hospitalization or follow-up | One year | 
| Rate of participants with cardiovascular death | Patients die of cardiac and cerebrovascular diseases during hospitalization or follow-up | One year | 
| Rate of participants with major adverse cardiac events (MACEs) | MACEs include cardiac death, stroke, and recurrent myocardial infarction. | One year | 
| Rate of participants with acute myocardial infarction | Chest pain patients are diagnosed as acute myocardial infarction based on fourth edition of guidelines for myocardial infarction | Twenty-four hours | 
| Rate of participants with acute pulmonary embolism | Chest pain patients are diagnosed as acute pulmonary embolism based on CT of pulmonary angiography. | Twenty-four hours | 
| Rate of participants with acute aortic dissection | Chest pain patients are diagnosed as acute aortic dissection based on CT of aortic angiography. | Twenty-four hours | 
| Rate of participants with acute coronary syndrome | Chest pain patients are diagnosed as acute coronary syndrome based on European Society of Cardiology (ESC) guidelines. | Twenty-four hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of participants with ischemia or necrosis of lower limbs | Patients complicate with ischemia or necrosis of lower limbs during hospitalization | Two weeks | 
| Rate of participants with acute heart failure | Patients complicate with acute heart failure during hospitalization | Two weeks | 
| Rate of participants with revascularization | Patients receive revascularization for recurrent angina or myocardial infarction during hospitalization | Two weeks | 
| Rate of participants with consciousness disorder | Patients complicate with consciousness disorder during hospitalization | Two weeks | 
| Rate of participants with cardiogenic shock | Patients complicate with cardiogenic shock during hospitalization | Two weeks | 
| Rate of participants with acute kidney injury | Patients complicate with acute kidney injury during hospitalization | Two weeks | 
| Rate of participants with malignant arrhythmia | Patients complicate with malignant arrhythmia during hospitalization | Two weeks | 
| Rate of participants with pericardial tamponade | Patients complicate with pericardial tamponade during hospitalization | Two weeks | 
| Rate of participants with bleeding | Patients complicate with bleeding | One year | 
| Rate of participants with multiple organ dysfunction syndrome | Patients complicate with multiple organ dysfunction syndrome during hospitalization | Two weeks | 
| Rate of participants with respiratory failure | Patients complicate with respiratory failure during hospitalization | Two weeks | 
| Rate of participants with cardiac arrest | The sudden termination of cardiac ejection function, the disappearance of great artery pulsation and heart sound, and severe ischemia and hypoxia of important organs (such as brain) lead to the termination of life. | Two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chest pain, Acute Aortic Dissection, Pulmonary Embolism, Acute Coronary Syndrome, Acute myocardial infarction, Risk stratification, Prognosis, Biomarkers