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

Pulmonary Embolism Clinical Trial

— TOMOBS  

Official title:

Time Trend Analysis of Pulmonary Embolism Diagnosis With SPECT V/Q: a Single Institution Observational Study From 2011 to 2016

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03657992
• Other study ID #: TOMOBS (29BRC18.0017)
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: May 30, 2018

Study information

• Verified date: August 2018
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic conclusion of all SPECT V/Q scans performed for a suspected acute PE	positive, negative, or non-conclusive	April 2011 to December 2016
Secondary	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.		up to 3 Months following the date of the SPECT V/Q scan