Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT03083093
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2017-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
CTEPH Identification an Standard Computerised Tomography Pulmonary Angiography in Pulmonary Embolism Patients
Sponsor:
Leiden University Medical Center
Organization:
Study Overview
Official Title:
Identification of CTEPH on Standard Computerised Tomography Pulmonary Angiography Performed in the Work-up of Suspected Pulmonary Embolism
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
InShapeIII
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)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: