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

Pulmonary Embolism Clinical Trial

Official title:

Performances de l'h-FABP Pour Identifier dès Les Urgences Les Embolies Pulmonaires d'évolution défavorable

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326507
• Other study ID #: 0900303
• Secondary ID: 2009-A00441-56
• Status: Completed
• Phase: N/A
• First received: November 6, 2009
• Last updated: May 10, 2017
• Start date: September 2009
• Est. completion date: December 2011

Study information

• Verified date: May 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Biological:
• Dosage de l'h-FABP
Dosage de l'h-FABP

Locations

Country	Name	City	State
France	Hôpital Rangueil Service des urgences	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

Lauque D, Maupas-Schwalm F, Bounes V, Juchet H, Bongard V, Roshdy A, Botella JM, Charpentier S. Predictive value of the heart-type fatty acid-binding protein and the Pulmonary Embolism Severity Index in patients with acute pulmonary embolism in the emerge — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of death by pulmonary embolism		1 month
Primary	life-threatening pulmonary embolism (cardiopulmonary arrest, shock, mechanical ventilation)		1 month
Primary	recurrent episode of pulmonary embolism		1 month
Secondary	prognostic value of a clinical score (PESI), BNP and troponin in acute pulmonary embolism		1 month