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

Leiden University Medical Center (LUMC)

Status

Completed

Conditions

Pulmonary Embolism

Early Diagnosis

CTEPH

Treatments

Diagnostic Test: The initial CTPA will be reviewed

Study type

Observational

Funder types

Other

Identifiers

NCT03083093

G17.014

Details and patient eligibility

About

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)"

Full 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)

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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