Prevalence of Pulmonary Embolism in Patients With Syncope

Not Applicable

Completed

• Conditions: Syncope; Pulmonary Embolism
• Interventions: Other: Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimer

• Registration Number: NCT01797289
• Lead Sponsor: University of Padova

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-02-20
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-22
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-22
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• first episode of syncope

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
First episode of loss of consciousness	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 Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To assess the prevalence of pulmonary embolism in patients with apparently unexplained syncope	Up to one week after hospital admission

Trial Locations

Locations (1)

Clinica Medica 2 University of Padua; 🇮🇹 Padua, Italy