CTEPH, Early Diagnosis, Pulmonary Embolism
Conditions
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)
Interventions
DIAGNOSTIC_TESTThe initial CTPA will be reviewed
The initial CTPA will be reviewed
Sponsors
Amsterdam UMC, location VUmc
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Leiden University Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CTEPH Patients the initial CTPA scan will be reviewed in patients diagnosed with CTEPH after an episode of an acute PE | 50 |
| Non CTEPH Patients the initial CTPA scan will be reviewed in patients after an episode of an acute PE in whom CTEPH was excluded | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Non CTEPH Patients | Total | CTEPH Patients |
|---|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 15 | 58 years STANDARD_DEVIATION 17 | 61 years STANDARD_DEVIATION 15 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Netherlands | 50 participants | 100 participants | 50 participants |
| Sex: Female, Male Female | 33 Participants | 60 Participants | 27 Participants |
| Sex: Female, Male Male | 17 Participants | 40 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CTEPH Patients | To Identify the Accuracy of Routine CTPA for the Distinction of CTEPH From Acute PE. | 70 Sensitivity |
| Non CTEPH Patients | To Identify the Accuracy of Routine CTPA for the Distinction of CTEPH From Acute PE. | 70 Sensitivity |