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Prevalence of Pulmonary Embolism in Patients With Syncope (PESY)

Primary Purpose

Syncope, Pulmonary Embolism

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimer
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Syncope focused on measuring syncope, pulmonary embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • first episode of syncope

Exclusion Criteria:

  • previous episodes of syncope
  • ongoing anticoagulation
  • age younger than 18 years
  • pregnancy

Sites / Locations

  • Clinica Medica 2 University of Padua

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

First episode of loss of consciousness

Arm Description

Outcomes

Primary Outcome Measures

To assess the prevalence of PE in a large series of consecutive patients presenting with the first episode of syncope

Secondary Outcome Measures

To assess the prevalence of pulmonary embolism in patients with apparently unexplained syncope

Full Information

First Posted
February 20, 2013
Last Updated
January 22, 2015
Sponsor
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT01797289
Brief Title
Prevalence of Pulmonary Embolism in Patients With Syncope
Acronym
PESY
Official Title
The Prevalence of Pulmonarym Embolism in Patients With the First Episode of Syncope
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Padova

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope, Pulmonary Embolism
Keywords
syncope, pulmonary embolism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
First episode of loss of consciousness
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimer
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To assess the prevalence of pulmonary embolism in patients with apparently unexplained syncope
Time Frame
Up to one week after hospital admission
Other Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: first episode of syncope Exclusion Criteria: previous episodes of syncope ongoing anticoagulation age younger than 18 years pregnancy
Facility Information:
Facility Name
Clinica Medica 2 University of Padua
City
Padua
ZIP/Postal Code
35128
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
27797317
Citation
Prandoni P, Lensing AW, Prins MH, Ciammaichella M, Perlati M, Mumoli N, Bucherini E, Visona A, Bova C, Imberti D, Campostrini S, Barbar S; PESIT Investigators. Prevalence of Pulmonary Embolism among Patients Hospitalized for Syncope. N Engl J Med. 2016 Oct 20;375(16):1524-1531. doi: 10.1056/NEJMoa1602172.
Results Reference
derived

Learn more about this trial

Prevalence of Pulmonary Embolism in Patients With Syncope

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