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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01326507
Recruitment Status : Completed
First Posted : March 31, 2011
Last Update Posted : May 12, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Biological: Dosage de l'h-FABP Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Performances de l'h-FABP Pour Identifier dès Les Urgences Les Embolies Pulmonaires d'évolution défavorable
Study Start Date : September 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Biological: Dosage de l'h-FABP
    Dosage de l'h-FABP

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

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01326507

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

Publications of Results:
Responsible Party: University Hospital, Toulouse Identifier: NCT01326507     History of Changes
Other Study ID Numbers: 0900303
2009-A00441-56 ( Other Identifier: Afssaps )
First Posted: March 31, 2011    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 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