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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04122573
Other study ID # WestChinaH1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date October 31, 2022

Study information

Verified date November 2019
Source West China Hospital
Contact Dongze Li, MBBS
Phone +86-28-85422461
Email dongze.li@ymail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date October 31, 2022
Est. primary completion date October 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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


Intervention

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

Locations

Country Name City State
China Chengdu Second People's Hospital Chengdu Sichuan
China Chengdu Shangjin Nanfu Hospital Chengdu Sichuan
China People's Hospital of Xindu District Chengdu Sichuan
China Sichuan Integrative Medicine Hospital Chengdu Sichuan
China West China Hospital, Sichuan University 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 Affiliated Hospital of Zunyi Medical University Zunyi Guizhou

Sponsors (1)

Lead Sponsor Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Length of stay Time between patient's visit and discharge Two weeks
Other Rate of re-admitted participants Re-admission after discharge within 6 months Six months
Primary Rate of participants with all-cause death Patients die of all causes during hospitalization or follow-up One year
Primary Rate of participants with cardiovascular death Patients die of cardiac and cerebrovascular diseases during hospitalization or follow-up One year
Primary Rate of participants with major adverse cardiac events (MACEs) MACEs include cardiac death, stroke, and recurrent myocardial infarction. One year
Primary 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
Primary 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
Primary 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
Primary 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 Rate of participants with ischemia or necrosis of lower limbs Patients complicate with ischemia or necrosis of lower limbs during hospitalization Two weeks
Secondary Rate of participants with acute heart failure Patients complicate with acute heart failure during hospitalization Two weeks
Secondary Rate of participants with revascularization Patients receive revascularization for recurrent angina or myocardial infarction during hospitalization Two weeks
Secondary Rate of participants with consciousness disorder Patients complicate with consciousness disorder during hospitalization Two weeks
Secondary Rate of participants with cardiogenic shock Patients complicate with cardiogenic shock during hospitalization Two weeks
Secondary Rate of participants with acute kidney injury Patients complicate with acute kidney injury during hospitalization Two weeks
Secondary Rate of participants with malignant arrhythmia Patients complicate with malignant arrhythmia during hospitalization Two weeks
Secondary Rate of participants with pericardial tamponade Patients complicate with pericardial tamponade during hospitalization Two weeks
Secondary Rate of participants with bleeding Patients complicate with bleeding One year
Secondary Rate of participants with multiple organ dysfunction syndrome Patients complicate with multiple organ dysfunction syndrome during hospitalization Two weeks
Secondary Rate of participants with respiratory failure Patients complicate with respiratory failure during hospitalization Two weeks
Secondary 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
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