跳至主要内容
临床试验/NCT03657992
NCT03657992已完成不适用

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

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,000
试验地点
1
主要终点
Diagnostic conclusion of all SPECT V/Q scans performed for a suspected acute PE

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Diagnostic conclusion of all SPECT V/Q scans performed for a suspected acute PE

时间窗: April 2011 to December 2016

positive, negative, or non-conclusive

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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