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

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Toulouse Identifier:
First received: November 6, 2009
Last updated: May 10, 2017
Last verified: May 2017
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.

Condition Intervention
Pulmonary Embolism Biological: Dosage de l'h-FABP

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: Performances de l'h-FABP Pour Identifier dès Les Urgences Les Embolies Pulmonaires d'évolution défavorable

Resource links provided by NLM:

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • number of death by pulmonary embolism [ Time Frame: 1 month ]
  • life-threatening pulmonary embolism (cardiopulmonary arrest, shock, mechanical ventilation) [ Time Frame: 1 month ]
  • recurrent episode of pulmonary embolism [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • prognostic value of a clinical score (PESI), BNP and troponin in acute pulmonary embolism [ Time Frame: 1 month ]

Enrollment: 165
Study Start Date: September 2009
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Dosage de l'h-FABP
    Dosage de l'h-FABP

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01326507

Hôpital Rangueil Service des urgences
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Principal Investigator: Dominique LAUQUE, MD University Hospital, Toulouse
  More Information

Responsible Party: University Hospital, Toulouse Identifier: NCT01326507     History of Changes
Other Study ID Numbers: 0900303
2009-A00441-56 ( Other Identifier: Afssaps )
Study First Received: November 6, 2009
Last Updated: May 10, 2017

Keywords provided by University Hospital, Toulouse:
pulmonary embolism
Heart-type fatty acid-binding protein
cardiac biomarkers
risk stratification

Additional relevant MeSH terms:
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases processed this record on June 23, 2017