Prevalence of Pulmonary Embolism in Patients With Syncope

NCT ID: NCT01797289

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-10-31

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.

Conditions

Syncope; Pulmonary Embolism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

First episode of loss of consciousness

Group Type: EXPERIMENTAL

Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimer

Intervention Type: OTHER

Interventions

Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimer

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• first episode of syncope

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Paolo Prandoni

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinica Medica 2 University of Padua

Padua, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 27797317 (View on PubMed)

Other Identifiers

52823P

Identifier Type: -

Identifier Source: org_study_id