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OpenTrials
Completed

NCT Number: NCT01797289

Prevalence of Pulmonary Embolism in Patients With Syncope

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.

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Key information

Conditions

Syncope Cardiovascular Diseases Consciousness Disorders Embolism Embolism and Thrombosis Lung Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pulmonary Embolism Respiratory Tract Diseases Signs and Symptoms Unconsciousness Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Medica 2 University of Padua

Padua, 35128, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • first episode of syncope

Exclusion criteria

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

Treatment and study plan

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

Other

Primary outcomes

  1. 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 outcomes

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

    Time frame: 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

    Time frame: Up to 48 hours after admission

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

The Prevalence of Pulmonarym Embolism in Patients With the First Episode of Syncope

Acronym: PESY

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 22, 2013
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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