Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism

Not Applicable

Completed

• Conditions: Pulmonary Embolism

• Registration Number: NCT01326507
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

The patients presenting with acute pulmonary embolism and right ventricular dysfunction are at high risk for life-threatening events and must be identified in the emergency department for adequate care and hospital admission. Echocardiography can identify right ventricular dysfunction, but this test is not always available, and echocardiographic criteria of right ventricular dysfunction vary among published studies. The primary purpose of this protocol is to study the prognostic value of a cardiac biomarker, h-FABP (heart-type Fatty Acid-Binding Protein) , to identify in the emergency department the patients presenting with high risk pulmonary embolism. As secondary outcomes, H-FABP results will be compared to other cardiac biomarkers (BNP, troponin) and clinical score performances that have been previously studied to stratify the prognosis of patients with pulmonary embolism in the emergency department.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-11-06
• Study First Submitted QC: 2011-03-29
• Study First Posted: 2011-03-31
• Primary Completion: 2011-06
• Study Completion: 2011-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• patients with acute pulmonary embolism diagnosed in the emergency departement

Exclusion Criteria

• patient under guardianship
• patient without social insurance
• pregnant women
• refusal to sign the consent
• myocardial infarction in the 10 days before pulmonary embolism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
number of death by pulmonary embolism	1 month
life-threatening pulmonary embolism (cardiopulmonary arrest, shock, mechanical ventilation)	1 month
recurrent episode of pulmonary embolism	1 month

Secondary Outcome Measures

Name	Time	Method
prognostic value of a clinical score (PESI), BNP and troponin in acute pulmonary embolism	1 month

Trial Locations

Locations (1)

Hôpital Rangueil Service des urgences; 🇫🇷 Toulouse, France