Prospective Multicenter Study for Early Evaluation of Acute Chest Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 10,000
- 试验地点
- 9
- 主要终点
- Rate of participants with cardiovascular death
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient aged 18-90 years old;
- •The time from onset of symptoms to emergency room is less than 24 hours.
排除标准
- •Patients complicate with end-stage neoplastic diseases;
- •Pregnant women;
- •Patients re-visit during the selection period;
- •Patients refuse to participate in this study.
结局指标
主要结局
Rate of participants with cardiovascular death
时间窗: One year
Patients die of cardiac and cerebrovascular diseases during hospitalization or follow-up
Rate of participants with major adverse cardiac events (MACEs)
时间窗: One year
MACEs include cardiac death, stroke, and recurrent myocardial infarction.
Rate of participants with acute pulmonary embolism
时间窗: Twenty-four hours
Chest pain patients are diagnosed as acute pulmonary embolism based on CT of pulmonary angiography.
Rate of participants with acute coronary syndrome
时间窗: Twenty-four hours
Chest pain patients are diagnosed as acute coronary syndrome based on European Society of Cardiology (ESC) guidelines.
Rate of participants with acute myocardial infarction
时间窗: Twenty-four hours
Chest pain patients are diagnosed as acute myocardial infarction based on fourth edition of guidelines for myocardial infarction
Rate of participants with all-cause death
时间窗: One year
Patients die of all causes during hospitalization or follow-up
Rate of participants with acute aortic dissection
时间窗: Twenty-four hours
Chest pain patients are diagnosed as acute aortic dissection based on CT of aortic angiography.
次要结局
- Rate of participants with consciousness disorder(Two weeks)
- Rate of participants with cardiogenic shock(Two weeks)
- Rate of participants with pericardial tamponade(Two weeks)
- Rate of participants with bleeding(One year)
- Rate of participants with cardiac arrest(Two weeks)
- Rate of participants with revascularization(Two weeks)
- Rate of participants with acute kidney injury(Two weeks)
- Rate of participants with multiple organ dysfunction syndrome(Two weeks)
- Rate of participants with ischemia or necrosis of lower limbs(Two weeks)
- Rate of participants with acute heart failure(Two weeks)
- Rate of participants with malignant arrhythmia(Two weeks)
- Rate of participants with respiratory failure(Two weeks)
研究者
Dongze Li
Lecturer, Clinical Research
West China Hospital