NCT04122573

Prospective Multicenter Study for Early Evaluation of Acute Chest Pain

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Coronary angiography	Acute chest pain patients, suspected acute coronary syndrome, are diagnosed by coronary angiography.
DIAGNOSTIC_TEST	CT angiography of aorta	Acute chest pain patients, suspected acute aortic dissection, are diagnosed by gold standard of CTA.
DIAGNOSTIC_TEST	CT angiography of pulmonary arteries.	Acute chest pain patients, suspected acute pulmonary embolism, are diagnosed by gold standard of CTA.
DIAGNOSTIC_TEST	Electrocardiogram	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.
DIAGNOSTIC_TEST	Cardiac Troponin	Dynamic changes of cardiac troponin I and/or T will be used in the diagnosis of acute myocardial infarction

Timeline

• Start date: 2019-11-01
• Primary completion: 2021-10-31
• Completion: 2022-10-31
• First posted: 2019-10-10
• Last updated: 2019-11-29

Locations

9 sites across 1 country: China