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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01326507
First received: November 6, 2009
Last updated: December 13, 2011
Last verified: December 2011
History of Changes
  Purpose

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: Open Label
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:

U.S. FDA Resources

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • number of death by pulmonary embolism [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • life-threatening pulmonary embolism (cardiopulmonary arrest, shock, mechanical ventilation) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • recurrent episode of pulmonary embolism [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • prognostic value of a clinical score (PESI), BNP and troponin in acute pulmonary embolism [ Time Frame: 1 month ] [ Designated as safety issue: No ]

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326507

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

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01326507     History of Changes
Other Study ID Numbers: 0900303, 2009-A00441-56
Study First Received: November 6, 2009
Last Updated: December 13, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 17, 2013