Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism
Performances de l'h-FABP Pour Identifier dès Les Urgences Les Embolies Pulmonaires d'évolution défavorable
2 other identifiers
interventional
165
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 6, 2009
CompletedFirst Posted
Study publicly available on registry
March 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMay 12, 2017
May 1, 2017
1.7 years
November 6, 2009
May 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
number of death by pulmonary embolism
1 month
life-threatening pulmonary embolism (cardiopulmonary arrest, shock, mechanical ventilation)
1 month
recurrent episode of pulmonary embolism
1 month
Secondary Outcomes (1)
prognostic value of a clinical score (PESI), BNP and troponin in acute pulmonary embolism
1 month
Interventions
Dosage de l'h-FABP
Eligibility Criteria
You may qualify if:
- patients with acute pulmonary embolism diagnosed in the emergency departement
You may not qualify if:
- patient under guardianship
- patient without social insurance
- pregnant women
- refusal to sign the consent
- myocardial infarction in the 10 days before pulmonary embolism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Rangueil Service des urgences
Toulouse, 31059, France
Related 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 emergency department. Acad Emerg Med. 2014 Oct;21(10):1143-50. doi: 10.1111/acem.12484.
PMID: 25308138RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dominique LAUQUE, MD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2009
First Posted
March 31, 2011
Study Start
September 1, 2009
Primary Completion
June 1, 2011
Study Completion
December 1, 2011
Last Updated
May 12, 2017
Record last verified: 2017-05