Prospective Multicenter Study for Early Evaluation of Acute Chest Pain

• Conditions: Acute Aortic Dissection; Chest Pain; Acute Coronary Syndrome; Pulmonary Embolism; Acute Myocardial Infarction Type 1
• Interventions: Diagnostic Test: Coronary angiography; Diagnostic Test: CT angiography of aorta; Diagnostic Test: CT angiography of pulmonary arteries.; Diagnostic Test: Electrocardiogram; Diagnostic Test: Cardiac Troponin

• Registration Number: NCT04122573
• Lead Sponsor: West China Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-10-06
• Study First Submitted QC: 2019-10-09
• Study First Posted: 2019-10-10
• Status Verified: 2019-11
• Study Start: 2019-11-01
• Last Update Submitted: 2019-11-27
• Last Update Posted: 2019-11-29
• Primary Completion: 2021-10-31
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute chest pain	CT angiography of aorta	The population in this study are characterized by acute chest pain as the first symptom for consultation within 24 hours.
Acute chest pain	CT angiography of pulmonary arteries.	The population in this study are characterized by acute chest pain as the first symptom for consultation within 24 hours.
Acute chest pain	Electrocardiogram	The population in this study are characterized by acute chest pain as the first symptom for consultation within 24 hours.
Acute chest pain	Coronary angiography	The population in this study are characterized by acute chest pain as the first symptom for consultation within 24 hours.
Acute chest pain	Cardiac Troponin	The population in this study are characterized by acute chest pain as the first symptom for consultation within 24 hours.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rate of participants with consciousness disorder	Two weeks	Patients complicate with consciousness disorder during hospitalization
Rate of participants with cardiogenic shock	Two weeks	Patients complicate with cardiogenic shock during hospitalization
Rate of participants with pericardial tamponade	Two weeks	Patients complicate with pericardial tamponade during hospitalization
Rate of participants with bleeding	One year	Patients complicate with bleeding
Rate of participants with cardiac arrest	Two weeks	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.
Rate of participants with revascularization	Two weeks	Patients receive revascularization for recurrent angina or myocardial infarction during hospitalization
Rate of participants with acute kidney injury	Two weeks	Patients complicate with acute kidney injury during hospitalization
Rate of participants with multiple organ dysfunction syndrome	Two weeks	Patients complicate with multiple organ dysfunction syndrome during hospitalization
Rate of participants with ischemia or necrosis of lower limbs	Two weeks	Patients complicate with ischemia or necrosis of lower limbs during hospitalization
Rate of participants with acute heart failure	Two weeks	Patients complicate with acute heart failure during hospitalization
Rate of participants with malignant arrhythmia	Two weeks	Patients complicate with malignant arrhythmia during hospitalization
Rate of participants with respiratory failure	Two weeks	Patients complicate with respiratory failure during hospitalization

Trial Locations

Locations (9)

Chengdu Second People's Hospital; 🇨🇳 Chengdu, Sichuan, China

Chengdu Shangjin Nanfu Hospital; 🇨🇳 Chengdu, Sichuan, China

Sichuan Integrative Medicine Hospital; 🇨🇳 Chengdu, Sichuan, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Affiliated Hospital of Zunyi Medical University; 🇨🇳 Zunyi, Guizhou, China

People's Hospital of Xindu District; 🇨🇳 Chengdu, Sichuan, China

Affiliated Hospital of Southwest Medical University; 🇨🇳 Luzhou, Sichuan, China

Panzhihua Central Hospital; 🇨🇳 Panzhihua, Sichuan, China

Zigong Fourth People's Hospital; 🇨🇳 Zigong, Sichuan, China