Clinical trial NCT03083093: CTEPH Identification an Standard Computerised Tomography Pulmonary Angiography in Pulmonary Embolism Patients
Official title: Identification of CTEPH on Standard Computerised Tomography Pulmonary Angiography Performed in the Work-up of Suspected Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CTEPH
Pulmonary Embolism
Early Diagnosis
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC, location VUmc
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2017-03-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
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.

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)"

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)

Eligibility 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

Primary outcomes:
measure: To Identify the Accuracy of Routine CTPA for the Distinction of CTEPH From Acute PE.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: LUMC
Study officials:
affiliation: LUMC department of thormbosis and hemostasis
name: F.A. Klok, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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