Prevalence of Pulmonary Embolism in Patients With Syncope

Pulmonary Embolism Clinical Trial

— PESY  

Official title:

The Prevalence of Pulmonarym Embolism in Patients With the First Episode of Syncope

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797289
• Other study ID #: 52823P
• Status: Completed
• Phase: N/A
• First received: February 20, 2013
• Last updated: January 22, 2015
• Start date: February 2012
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• first episode of syncope

Exclusion Criteria:

• previous episodes of syncope

• ongoing anticoagulation

• age younger than 18 years

• pregnancy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Syncope

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

Locations

Country	Name	City	State
Italy	Clinica Medica 2 University of Padua	Padua

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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		Up to 48 hours after admission	No
Primary	To assess the prevalence of PE in a large series of consecutive patients presenting with the first episode of syncope		Up to 48 hours after hospital admission	No
Secondary	To assess the prevalence of pulmonary embolism in patients with apparently unexplained syncope		Up to one week after hospital admission	No