Evaluation of Performances of Biomarkers in Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Area under the ROC curve of biomarkers for the diagnosis of PE
研究概览
简要总结
The purpose of the study is to evaluate the value of biomarkers in the diagnosis and risk stratification of patients with suspected pulmonary embolism.
详细描述
Management of patients with acute pulmonary embolism is a serious problem. The rapid and accurate diagnosis and risk stratification of these patients is an important unmet clinical need. The aim of the study is to evaluate the value of biomarkers, alone or in combination, in the diagnosis and risk stratification of patients with suspected pulmonary embolism presenting to the emergency department.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient aged ≥ 18 years that presents to an emergency department
- •With suspected PE defined as new onset of or worsening of shortness of breath or chest pain
排除标准
- •Hemodynamic instability
- •Life expectancy less than 3 months
- •First symptoms 15 day or more before inclusion
- •Inability to the follow-up visits
- •Therapeutic anticoagulation for any indication
结局指标
主要结局
Area under the ROC curve of biomarkers for the diagnosis of PE
时间窗: 2 years
The ROC curve will be built, the area under the curve will be calculated with its confidence interval.
PE related death
时间窗: 7 days
Number of PE related death
次要结局
- Symptomatic recurrent venous thromboembolic events(2 years)