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Completed

NCT Number: NCT03657992

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

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.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest

Brest, 29609, France

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: TOMOBS

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 5, 2018
Registry last updated
Sep 5, 2018

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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