A Registry Study on Biomarkers of Pulmonary Embolism (BIO-PE)

Beijing Institute of Heart, Lung and Blood Vessel Diseases

Status: Unknown

Conditions: Pulmonary Embolism

Study type: Observational

Funder types: Other

Identifiers

NCT04118634

PE2019

Details and patient eligibility

About

The purpose of the study is to evaluate the value of biomarkers in the diagnosis and risk stratification of patients with suspected pulmonary embolism.

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

480 participants in 2 patient groups

Group with PE

Description:

The criteria for confirmation of PE are: PE on spiral computed tomography (CT) proximal deep vein thrombosis on ultrasound (US) thromboembolic events objectively confirmed during the follow up

Group without PE

Description:

The criteria for exclusion of PE are: low or moderate clinical probability and D-dimer ELISA \<0.50 µg/mL or \<10xage in patients older than 50 years and negative follow up low and moderate clinical probability and negative CT and negative follow up high clinical probability and negative CT, US and follow up.