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Prevalence of Pulmonary Embolism in Patients With Syncope (PESY)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01797289
First Posted: February 22, 2013
Last Update Posted: January 26, 2015
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.
Information provided by (Responsible Party):
Paolo Prandoni, University of Padova
  Purpose
All patients consecutively referred with the first episode of transient and short-lasting loss of consciousness will have a diagnostic workup for the assessment of the most common causes of syncope, and will be evaluated for the presence of pulmonary embolism (PE) with the use of an internationally accepted algorithm including a pre-test clinical probability (PTP according to the method of Wells et al.) and a high-sensitivity quantitative D-dimer assay. If the PTP is low and D-dimer negative, PE will be excluded. All other patients will undergo confirmatory diagnostic tests (either computerized tomography or ventilation/perfusion lung scanning) in order to confirm or rule out the presence of PE.

Condition Intervention
Syncope Pulmonary Embolism Other: Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimer

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Prevalence of Pulmonarym Embolism in Patients With the First Episode of Syncope

Resource links provided by NLM:


Further study details as provided by Paolo Prandoni, University of Padova:

Primary Outcome Measures:
  • To assess the prevalence of PE in a large series of consecutive patients presenting with the first episode of syncope [ Time Frame: Up to 48 hours after hospital admission ]

Secondary Outcome Measures:
  • To assess the prevalence of pulmonary embolism in patients with apparently unexplained syncope [ Time Frame: Up to one week after hospital admission ]

Other Outcome Measures:
  • To assess the prevalence of pulmonary embolism in patients with syncope with a high pre-test probability of PE and/or a positive D-dimer [ Time Frame: Up to 48 hours after admission ]

Enrollment: 600
Study Start Date: February 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: First episode of loss of consciousness Other: Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimer

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • first episode of syncope

Exclusion Criteria:

  • previous episodes of syncope
  • ongoing anticoagulation
  • age younger than 18 years
  • pregnancy
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01797289


Locations
Italy
Clinica Medica 2 University of Padua
Padua, Italy, 35128
Sponsors and Collaborators
University of Padova
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paolo Prandoni, Professor, University of Padova
ClinicalTrials.gov Identifier: NCT01797289     History of Changes
Other Study ID Numbers: 52823P
First Submitted: February 20, 2013
First Posted: February 22, 2013
Last Update Posted: January 26, 2015
Last Verified: January 2015

Keywords provided by Paolo Prandoni, University of Padova:
syncope
pulmonary embolism

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Syncope
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms


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