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OpenTrials
Completed

NCT Number: NCT01326507

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Rangueil Service des urgences

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dosage de l'h-FABP

Biological

Dosage de l'h-FABP

Primary outcomes

  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 outcomes

  1. prognostic value of a clinical score (PESI), BNP and troponin in acute pulmonary embolism

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Performances de l'h-FABP Pour Identifier dès Les Urgences Les Embolies Pulmonaires d'évolution défavorable

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 31, 2011
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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