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Prevalence of Pulmonary Embolism in Patients With Syncope (PESY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Padova
Sponsor:
Information provided by (Responsible Party):
Paolo Prandoni, University of Padova
ClinicalTrials.gov Identifier:
NCT01797289
First received: February 20, 2013
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Syncope
Pulmonary Embolism
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 Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Prevalence of Pulmonarym Embolism in Patients With the First Episode of Syncope

Resource links provided by NLM:


Further study details as provided by University of Padova:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the prevalence of pulmonary embolism in patients with apparently unexplained syncope [ Time Frame: Up to one week after hospital admission ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 554
Study Start Date: February 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: First episode of loss of consciousness Other: Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • first episode of syncope

Exclusion Criteria:

  • previous episodes of syncope
  • ongoing anticoagulation
  • age younger than 18 years
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01797289

Contacts
Contact: Paolo Prandoni, MD 0039-049-8212656 paolo.prandoni@unipd.it

Locations
Italy
Clinica Medica 2 University of Padua Recruiting
Padua, Italy, 35128
Contact: Paolo Prandoni, MD    0069-049-8212656      
Sub-Investigator: Sofia Barbar, MD         
Sponsors and Collaborators
University of Padova
  More Information

No publications provided

Responsible Party: Paolo Prandoni, Professor, University of Padova
ClinicalTrials.gov Identifier: NCT01797289     History of Changes
Other Study ID Numbers: 52823P
Study First Received: February 20, 2013
Last Updated: February 22, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Padova:
syncope
pulmonary embolism

Additional relevant MeSH terms:
Syncope
Embolism
Pulmonary Embolism
Cardiovascular Diseases
Consciousness Disorders
Embolism and Thrombosis
Lung Diseases
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Respiratory Tract Diseases
Signs and Symptoms
Unconsciousness
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014