Prevalence of Pulmonary Embolism in Patients With Syncope (PESY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Padova
Sponsor:
Information provided by (Responsible Party):
Paolo Prandoni, University of Padova
ClinicalTrials.gov Identifier:
NCT01797289
First received: February 20, 2013
Last updated: February 22, 2013
Last verified: February 2013

February 20, 2013
February 22, 2013
February 2012
February 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01797289 on ClinicalTrials.gov Archive Site
To assess the prevalence of pulmonary embolism in patients with apparently unexplained syncope [ Time Frame: Up to one week after hospital admission ] [ Designated as safety issue: No ]
Same as current
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 ] [ Designated as safety issue: No ]
Same as current
 
Prevalence of Pulmonary Embolism in Patients With Syncope
The Prevalence of Pulmonarym Embolism in Patients With the First Episode of Syncope

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • 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
Experimental: First episode of loss of consciousness
Intervention: Other: Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
554
February 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • first episode of syncope

Exclusion Criteria:

  • previous episodes of syncope
  • ongoing anticoagulation
  • age younger than 18 years
  • pregnancy
Both
18 Years and older
No
Contact: Paolo Prandoni, MD 0039-049-8212656 paolo.prandoni@unipd.it
Italy
 
NCT01797289
52823P
Yes
Paolo Prandoni, University of Padova
University of Padova
Not Provided
Not Provided
University of Padova
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP