CTEPH Identification an Standard Computerised Tomography Pulmonary Angiography in Pulmonary Embolism Patients (InShapeIII)

March 18, 2021 updated by: Erik Klok, Leiden University Medical Center

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

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)"

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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)

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The CTPA scans of the following patient populations will be compared. The first group consists of patients with confirmed CTEPH after a prior diagnosis of acute PE. The control group consists of patients with an episode of acute PE in whom CTEPH was excluded after 2 years of follow-up by echocardiography. The CTPA scans of case and control patients will be matched according to the right-to-left ventricule diameter ratio.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CTEPH patients
the initial CTPA scan will be reviewed in patients diagnosed with CTEPH after an episode of an acute PE
Diagnostic test: The initial CTPA will be reviewed
The initial CTPA will be reviewed
non CTEPH patients
the initial CTPA scan will be reviewed in patients after an episode of an acute PE in whom CTEPH was excluded
Diagnostic test: The initial CTPA will be reviewed
The initial CTPA will be reviewed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Collaborators

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

Investigators

  • Principal Investigator: F.A. Klok, MD PhD, LUMC department of thormbosis and hemostasis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

March 8, 2017

First Submitted That Met QC Criteria

March 13, 2017

First Posted (Actual)

March 17, 2017

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

March 18, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G17.014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

this has to be planned

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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