Prospective Multicenter Study for Early Evaluation of Acute Chest Pain

Acute Coronary Syndrome Clinical Trial

— PEACP  

Official title:

Prospective Multicenter Study for Early Evaluation of Acute Chest Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04122573
• Other study ID #: WestChinaH1
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

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

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