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

Leiden University Medical Center100 enrolled

Overview

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)"

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

100

Conditions

CTEPH Pulmonary Embolism Early Diagnosis

Interventions

The initial CTPA will be reviewedDIAGNOSTIC_TEST

The initial CTPA will be reviewed

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

LUMC

Leiden, Netherlands

Outcomes

Primary Outcomes

To Identify the Accuracy of Routine CTPA for the Distinction of CTEPH From Acute PE.

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.

Time frame: 1 year

Data from ClinicalTrials.gov

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