Clinical trial NCT04122573: Prospective Multicenter Study for Early Evaluation of Acute Chest Pain
Official title: Prospective Multicenter Study for Early Evaluation of Acute Chest Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chest Pain
Acute Aortic Dissection
Pulmonary Embolism
Acute Myocardial Infarction Type 1
Acute Coronary Syndrome
Keywords: Chest pain
Acute Aortic Dissection
Pulmonary Embolism
Acute Coronary Syndrome
Acute myocardial infarction
Risk stratification
Prognosis
Biomarkers
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of participants with all-cause death
timeFrame: One year
measure: Rate of participants with cardiovascular death
timeFrame: One year
measure: Rate of participants with major adverse cardiac events (MACEs)
timeFrame: One year
measure: Rate of participants with acute myocardial infarction
timeFrame: Twenty-four hours
measure: Rate of participants with acute pulmonary embolism
timeFrame: Twenty-four hours
measure: Rate of participants with acute aortic dissection
timeFrame: Twenty-four hours
measure: Rate of participants with acute coronary syndrome
timeFrame: Twenty-four hours
Secondary outcomes:
measure: Rate of participants with ischemia or necrosis of lower limbs
timeFrame: Two weeks
measure: Rate of participants with acute heart failure
timeFrame: Two weeks
measure: Rate of participants with revascularization
timeFrame: Two weeks
measure: Rate of participants with consciousness disorder
timeFrame: Two weeks
measure: Rate of participants with cardiogenic shock
timeFrame: Two weeks
measure: Rate of participants with acute kidney injury
timeFrame: Two weeks
measure: Rate of participants with malignant arrhythmia
timeFrame: Two weeks
measure: Rate of participants with pericardial tamponade
timeFrame: Two weeks
measure: Rate of participants with bleeding
timeFrame: One year
measure: Rate of participants with multiple organ dysfunction syndrome
timeFrame: Two weeks
measure: Rate of participants with respiratory failure
timeFrame: Two weeks
measure: Rate of participants with cardiac arrest
timeFrame: Two weeks
Other outcomes:
measure: Length of stay
timeFrame: Two weeks
measure: Rate of re-admitted participants
timeFrame: Six months
Locations:
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Chengdu
country: China
facility: Chengdu Second People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Shangjin Nanfu Hospital
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Integrative Medicine Hospital
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: People's Hospital of Xindu District
state: Sichuan
city: Luzhou
country: China
facility: Affiliated Hospital of Southwest Medical University
state: Sichuan
city: Panzhihua
country: China
facility: Panzhihua Central Hospital
state: Sichuan
city: Zigong
country: China
facility: Zigong Fourth People's Hospital
state: Sichuan
Study officials:
affiliation: Emergency Department, West China Hospital, Sichuan University
name: Dongze Li, MBBS
role: PRINCIPAL_INVESTIGATOR
References: