An observational study in Chest Pain, Acute Aortic Dissection and Pulmonary Embolism, sponsored by West China Hospital. Status unknown at 9 sites in China. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-29.
Sponsored by West China Hospital · Observational
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.
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.
739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 392 across 324 observational studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →West China Hospital is the lead sponsor of 483 studies on the registry; 240 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The population in this study is characterized by acute chest pain as the first symptom for consultation. These are mainly Han and Tibetan patients from southwest China. The study population included first-visit and referral patients.
Exclusion Criteria:
The population in this study are characterized by acute chest pain as the first symptom for consultation within 24 hours.
Diagnostic Test: Coronary angiography · Diagnostic Test: CT angiography of aorta · Diagnostic Test: CT angiography of pulmonary arteries. · Diagnostic Test: Electrocardiogram · Diagnostic Test: Cardiac Troponin
Acute chest pain patients, suspected acute coronary syndrome, are diagnosed by coronary angiography.
Acute chest pain patients, suspected acute aortic dissection, are diagnosed by gold standard of CTA.
Also known as: CTA
Acute chest pain patients, suspected acute pulmonary embolism, are diagnosed by gold standard of CTA.
Also known as: CTA
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.
Also known as: ECG
Dynamic changes of cardiac troponin I and/or T will be used in the diagnosis of acute myocardial infarction
Also known as: Biomarkers of myocardial injury
Rate of participants with all-cause death
Patients die of all causes during hospitalization or follow-up
Time frame: One year
Rate of participants with cardiovascular death
Patients die of cardiac and cerebrovascular diseases during hospitalization or follow-up
Time frame: One year
Rate of participants with major adverse cardiac events (MACEs)
MACEs include cardiac death, stroke, and recurrent myocardial infarction.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Twenty-four hours
Rate of participants with ischemia or necrosis of lower limbs
Patients complicate with ischemia or necrosis of lower limbs during hospitalization
Time frame: Two weeks
Rate of participants with acute heart failure
Patients complicate with acute heart failure during hospitalization
Time frame: Two weeks
Rate of participants with revascularization
Patients receive revascularization for recurrent angina or myocardial infarction during hospitalization
Time frame: Two weeks
Rate of participants with consciousness disorder
Patients complicate with consciousness disorder during hospitalization
Time frame: Two weeks
Rate of participants with cardiogenic shock
Patients complicate with cardiogenic shock during hospitalization
Time frame: Two weeks
Rate of participants with acute kidney injury
Patients complicate with acute kidney injury during hospitalization
Time frame: Two weeks
Rate of participants with malignant arrhythmia
Patients complicate with malignant arrhythmia during hospitalization
Time frame: Two weeks
Rate of participants with pericardial tamponade
Patients complicate with pericardial tamponade during hospitalization
Time frame: Two weeks
Rate of participants with bleeding
Patients complicate with bleeding
Time frame: One year
Rate of participants with multiple organ dysfunction syndrome
Patients complicate with multiple organ dysfunction syndrome during hospitalization
Time frame: Two weeks
Rate of participants with respiratory failure
Patients complicate with respiratory failure during hospitalization
Time frame: 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.
Time frame: Two weeks
Length of stay
Time between patient's visit and discharge
Time frame: Two weeks
Rate of re-admitted participants
Re-admission after discharge within 6 months
Time frame: Six months
Plan to share: Yes — This study will share individual participant data (IPD) including patient characteristics, vital signs, laboratory examinations, imaging examinations, diagnosis, adverse events in hospital and long-term prognosis.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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West China Hospital