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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03083093
Recruitment Status : Completed
First Posted : March 17, 2017
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
VU University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
Erik Klok, Leiden University Medical Center

Brief Summary:
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)"

Condition or disease Intervention/treatment
CTEPH Pulmonary Embolism Early Diagnosis Diagnostic Test: The initial CTPA will be reviewed

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)

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Identification of CTEPH on Standard Computerised Tomography Pulmonary Angiography Performed in the Work-up of Suspected Pulmonary Embolism
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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.


Secondary Outcome Measures :
  1. The interobserver agreement using cohens kappa statistic for each of the scored items suggestive of CTEPH [ Time Frame: 1 year ]
    The kappa value for agreement will be interpreted as follows: poor (< 0.20), fair (0.21-0.40), moderate (0.41-0.60), good (0.61-0.80) or very good (0.81-1.00)

  2. the predictive value of each of the individual scored items suggestive of CTEPH [ Time Frame: 1 year ]
    the predicitve value will be determined by using a single variate analysis

  3. assessment of most predictive individual scored items suggestive of CTEPH [ Time Frame: 1 year ]
    the most predicitve individual scores items will be determined by using a multivariate analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083093


Locations
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Netherlands
LUMC
Leiden, Netherlands, 2333 ZA
Sponsors and Collaborators
Leiden University Medical Center
VU University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: F.A. Klok, MD PhD LUMC department of thormbosis and hemostasis

Publications:

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Responsible Party: Erik Klok, principal investigator, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT03083093    
Other Study ID Numbers: G17.014
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: this has to be planned

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases