Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism
Primary Purpose
Pulmonary Embolism
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dosage de l'h-FABP
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Embolism focused on measuring pulmonary embolism, Heart-type fatty acid-binding protein, cardiac biomarkers, risk stratification
Eligibility 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
Sites / Locations
- Hôpital Rangueil Service des urgences
Outcomes
Primary Outcome Measures
number of death by pulmonary embolism
life-threatening pulmonary embolism (cardiopulmonary arrest, shock, mechanical ventilation)
recurrent episode of pulmonary embolism
Secondary Outcome Measures
prognostic value of a clinical score (PESI), BNP and troponin in acute pulmonary embolism
Full Information
NCT ID
NCT01326507
First Posted
November 6, 2009
Last Updated
May 10, 2017
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT01326507
Brief Title
Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism
Official Title
Performances de l'h-FABP Pour Identifier dès Les Urgences Les Embolies Pulmonaires d'évolution défavorable
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
pulmonary embolism, Heart-type fatty acid-binding protein, cardiac biomarkers, risk stratification
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Dosage de l'h-FABP
Intervention Description
Dosage de l'h-FABP
Primary Outcome Measure Information:
Title
number of death by pulmonary embolism
Time Frame
1 month
Title
life-threatening pulmonary embolism (cardiopulmonary arrest, shock, mechanical ventilation)
Time Frame
1 month
Title
recurrent episode of pulmonary embolism
Time Frame
1 month
Secondary Outcome Measure Information:
Title
prognostic value of a clinical score (PESI), BNP and troponin in acute pulmonary embolism
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique LAUQUE, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Rangueil Service des urgences
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
25308138
Citation
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 emergency department. Acad Emerg Med. 2014 Oct;21(10):1143-50. doi: 10.1111/acem.12484.
Results Reference
result
Learn more about this trial
Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism
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