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

Completed
Conditions
CTEPH
Pulmonary Embolism
Early Diagnosis
Interventions
Diagnostic Test: The initial CTPA will be reviewed
Registration Number
NCT03083093
Lead Sponsor
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)"

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)

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
non CTEPH patientsThe initial CTPA will be reviewedthe initial CTPA scan will be reviewed in patients after an episode of an acute PE in whom CTEPH was excluded
CTEPH patientsThe initial CTPA will be reviewedthe initial CTPA scan will be reviewed in patients diagnosed with CTEPH after an episode of an acute PE
Primary Outcome Measures
NameTimeMethod
To Identify the Accuracy of Routine CTPA for the Distinction of CTEPH From Acute PE.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
NameTimeMethod

Trial Locations

Locations (1)

LUMC

🇳🇱

Leiden, Netherlands

LUMC
🇳🇱Leiden, Netherlands
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