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What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - first episode of syncope Exclusion Criteria: - previous episodes of syncope - ongoing anticoagulation - age younger than 18 years - pregnancy

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Syncope

Pulmonary Embolism

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

First episode of loss of consciousness

Study Status

Completed

Start Date: February 2012

Completed Date: October 2014

Phase: N/A

Type: Interventional

Design:

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

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

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: University of Padova

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01797289