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A Registry Study on Biomarkers of Pulmonary Embolism

Conditions
Pulmonary Embolism
Registration Number
NCT04118634
Lead Sponsor
Beijing Institute of Heart, Lung and Blood Vessel Diseases
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
480
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Area under the ROC curve of biomarkers for the diagnosis of PE2 years

The ROC curve will be built, the area under the curve will be calculated with its confidence interval.

PE related death7 days

Number of PE related death

Secondary Outcome Measures
NameTimeMethod
Symptomatic recurrent venous thromboembolic events2 years

Number of symptomatic recurrent venous thromboembolic event

Trial Locations

Locations (1)

Beijing Anzhen Hospital

🇨🇳

Beijing, Beijing, China

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