Evaluation of Performances of Biomarkers in Pulmonary Embolism
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary Embolism
- Sponsor
- Beijing Institute of Heart, Lung and Blood Vessel Diseases
- Enrollment
- 480
- Locations
- 1
- Primary Endpoint
- Area under the ROC curve of biomarkers for the diagnosis of PE
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of the study is to evaluate the value of biomarkers in the diagnosis and risk stratification of patients with suspected pulmonary embolism.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Area under the ROC curve of biomarkers for the diagnosis of PE
Time Frame: 2 years
The ROC curve will be built, the area under the curve will be calculated with its confidence interval.
PE related death
Time Frame: 7 days
Number of PE related death
Secondary Outcomes
- Symptomatic recurrent venous thromboembolic events(2 years)