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Time Trend Analysis of PE Diagnosis With SPECT V/Q: a Single Institution Observational Study (TOMOBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03657992
Recruitment Status : Completed
First Posted : September 5, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:
Following the implementation of SPECT V/Q imaging for PE diagnosis, the investigators previously conducted an observational study over the period 2011-2013 that showed the safety of a diagnostic management based on SPECT V/Q to rule out PE. However, PE prevalence was high (28%), which may seem a bit high as compared with other recent studies. The hypothesis was that the use of SPECT V/Q may be responsible for an overdiagnosis of PE, especially at the implementation phase of the test. The aim of this study was to perform a time trend analysis of the evolution over the years of PE diagnosis with SPECT V/Q.

Condition or disease
Pulmonary Embolism

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Study Type : Observational
Actual Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Time Trend Analysis of Pulmonary Embolism Diagnosis With SPECT V/Q: a Single Institution Observational Study From 2011 to 2016
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Diagnostic conclusion of all SPECT V/Q scans performed for a suspected acute PE [ Time Frame: April 2011 to December 2016 ]
    positive, negative, or non-conclusive


Secondary Outcome Measures :
  1. Risk of thromboembolic events (i.e. objectively confirmed pulmonary embolism or proximal deep vein thrombosis) during the 3-month follow-up period in patients left untreated based on a negative SPECT V/Q. [ Time Frame: up to 3 Months following the date of the SPECT V/Q scan ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent a SPECT V/Q scan performed for a suspected acute PE in the Nuclear Medicine Department of Brest University Hospital from April 2011 to December 2016
Criteria

Inclusion Criteria:

  • Patients who underwent a SPECT V/Q scan performed for a suspected acute PE in the Nuclear Medicine Department of Brest University Hospital from April 2011 to December 2016

Exclusion Criteria:

  • Patient under legal or judicial protection
  • Patient opposed to the use of his medical data for research.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657992


Locations
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France
CHRU de Brest
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03657992    
Other Study ID Numbers: TOMOBS (29BRC18.0017)
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases