Completed

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

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What is being tested

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

Other
Who is being recruted

Cardiovascular Diseases+12

+ Consciousness Disorders

+ Embolism

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: February 2012
See protocol details

Summary

Principal SponsorUniversity of Padova
Last updated: January 26, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01797289
Principal SponsorUniversity of Padova
Last updated: January 26, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

600 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesConsciousness DisordersEmbolismLung DiseasesNervous System DiseasesNeurologic ManifestationsRespiratory Tract DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsUnconsciousnessVascular DiseasesEmbolism and ThrombosisNeurobehavioral ManifestationsPulmonary EmbolismSyncope

Criteria

1 inclusion criteria required to participate
first episode of syncope
4 exclusion criteria prevent from participating
age younger than 18 years
ongoing anticoagulation
pregnancy
previous episodes of syncope

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Clinica Medica 2 University of Padua

Padua, ItalyOpen Clinica Medica 2 University of Padua in Google Maps
CompletedOne Study Center