A Registry Study on Biomarkers of Pulmonary Embolism

Pulmonary Embolism Clinical Trial

— BIO-PE  

Official title:

Evaluation of Performances of Biomarkers in Pulmonary Embolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04118634
• Other study ID #: PE2019
• Status: Recruiting
• Start date: April 18, 2015
• Est. completion date: August 2021

Study information

• Verified date: September 2019
• Source: Beijing Institute of Heart, Lung and Blood Vessel Diseases
• Contact: Yulin Li, PhD
• Phone: 0086-010-64456453
• Email: lyllyl_1111[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Institute of Heart, Lung and Blood Vessel Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the ROC curve of biomarkers for the diagnosis of PE	The ROC curve will be built, the area under the curve will be calculated with its confidence interval.	2 years
Primary	PE related death	Number of PE related death	7 days
Secondary	Symptomatic recurrent venous thromboembolic events	Number of symptomatic recurrent venous thromboembolic event	2 years