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OpenTrials
Completed

NCT Number: NCT03083093

CTEPH Identification an Standard Computerised Tomography Pulmonary Angiography in Pulmonary Embolism Patients

In this study the investigators will evaluate whether more careful reading (than the current standard) of routine computerised tomography pulmonary angiography (CTPA) performed in the clinical work-up of suspected (pulmonary embolism (PE) will differentiate patients with acute PE from those with more chronic or acute on chronic PE, which could be indicative of the presence of chronic thromboembolic pulmonary hypertension (CTEPH)"

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LUMC

Leiden, 2333 ZA, Netherlands

About this study

The investigators will study 50 consecutive patients diagnosed with CTEPH as well as 50 patients diagnosed with acute PE in whom CTEPH was ruled out 2 years after the PE diagnosis by sequential echocardiography. The cases and controls will be matched based on the right-to-left ventrilcle diameter ratio.

Three experienced thorax radiologists with specific expertise on acute PE and CTEPH will blindly assess the index CTPAs of the study population. In addition to the binominal judgement whether CTEPH signs are already present (or not), the presence of the following items will be scored by all 3 readers independently:

  • Webs or bands
  • Residual thrombus attached to the vascular wall
  • Complete occlusion /retraction
  • Mosaic perfusion
  • Pulmonary infarct
  • Parenchymal bands
  • Bronchial arteries
  • Right atrial (RA) dilatation
  • Right ventricle (RV) dilatation
  • Flattening of the septum
  • Right ventricle (RV) hypertrophy
  • Dilated truncus pulmonalis
  • Cardiac signs of pulmonary hypertension (PH)
  • Further remarks (free text)

Who can participate

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

Inclusion criteria

  • patients after an acute PE diagnosed with CTEPH according to current guidelines, patients after an acute PE in whom CTEPH is excluded by follow-up echocardiography
  • availability of the CTPA scan of the initial PE episode

Exclusion criteria

  • CTEPH diagnosis based on other test results than a RHC
  • Patients who did not receive anticoagulation after PE diagnosis
  • Patients under the age of 18 years old
  • Patients in the control group with a follow-up duration of less than 2 years after the index PE episode
  • Use of a CTPA scanner with less than 32-detector rows

Treatment and study plan

The initial CTPA will be reviewed

Diagnostic Test

The initial CTPA will be reviewed

Primary outcomes

  1. To Identify the Accuracy of Routine CTPA for the Distinction of CTEPH From Acute PE.

    Time frame: 1 year

    The sensitivity of CTPA is determined by calculating the proportion of scans that are read as "positive for the CTEPH specific radiological pattern" in patients with confirmed CTEPH and the specificity is determined by calculating the proportion of scans that are read as "negative for the CTEPH specific radiological pattern" in patients without CTEPH.

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Amsterdam UMC, location VUmc

Registry information

Official study title

Identification of CTEPH on Standard Computerised Tomography Pulmonary Angiography Performed in the Work-up of Suspected Pulmonary Embolism

Acronym: InShapeIII

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 17, 2017
Registry last updated
Apr 19, 2021

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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