Prevalence of Pulmonary Embolism in Patients With Syncope
PESY
The Prevalence of Pulmonarym Embolism in Patients With the First Episode of Syncope
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 20, 2013
CompletedFirst Posted
Study publicly available on registry
February 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedJanuary 26, 2015
January 1, 2015
2.7 years
February 20, 2013
January 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
To assess the prevalence of pulmonary embolism in patients with apparently unexplained syncope
Up to one week after hospital admission
Other Outcomes (1)
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
Study Arms (1)
First episode of loss of consciousness
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- first episode of syncope
You may not qualify if:
- previous episodes of syncope
- ongoing anticoagulation
- age younger than 18 years
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinica Medica 2 University of Padua
Padua, 35128, Italy
Related Publications (1)
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.
PMID: 27797317DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 20, 2013
First Posted
February 22, 2013
Study Start
February 1, 2012
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
January 26, 2015
Record last verified: 2015-01