CHRU Brest
Brest, 29200, France
NCT Number: NCT03579849
* Pulmonary embolism (PE) is a diagnostic and therapeutic challenge. The risk of death of untreated PE is approximately 25%. On the other hand, anticoagulant treatment is associated with a haemorrhagic risk (2% of major haemorrhagic accidents per year, of which 10% are fatal). A diagnostic accuracy is therefore necessary. * Two approaches are available to diagnose PE:
1. A functional approach, represented by pulmonary ventilation / perfusion scintigraphy (V / P), which looks for the functional consequences of PE. The main disadvantage of this approach is that there is a high rate of non-diagnostic examinations. On the other hand, it allows a mapping of pulmonary perfusion at the microcapillary scale, and thus allows the quantification of the vascular obstruction index, which would be an independent risk factor of PE recurrence. 2. A morphological approach, represented by CT pulmonary angiography (CTPA), which allows the visualisation of the clot itself. This approach is currently the most used but has some limitations, including a risk of over-diagnosis of pulmonary embolism and the inability to reliably quantify the index of vascular obstruction.
Lung subtraction iodine mapping CT is a new technique allowing, during the realization of a CTPA, without additional irradiation, to provide a mapping of the iodine. This mapping of iodine could potentially be used to evaluate pulmonary perfusion.
It would then be possible to obtain, during a single examination, in addition to the anatomical information of the thoracic angioscan, information on the pulmonary perfusion and thus to assess the functional consequences of PE.
No study to date has evaluated the performance of the pulmonary subtraction CT for the evaluation of pulmonary perfusion in the context of acute pulmonary embolism suspicion.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Brest, 29200, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The included patients will benefit from pulmonary tomoscintigraphy within 24 hours after the diagnosis of pulmonary embolism. Each tomoscintigraphy will be interpreted blindly by 3 nuclear physicians. Each of the 20 lung segments will be interpreted as normoperfused or hypoperfused.
Time frame: 24 hours
The sensitivity of iodine mapping by subtraction technique for the detection of perfusion defects in pulmonary embolism is evaluated with using pulmonary perfusion tomoscintigraphy as a reference standard .
Time frame: 24 hours
The specificity of iodine mapping by subtraction technique for the detection of perfusional defects in acute pulmonary embolism is determinated with using pulmonary perfusion tomoscintigraphy as reference standard.
Time frame: 24 hours
Thé correlation between the pulmonary vascular obstruction index measured by iodine mapping by subtraction technique and that obtained by perfusion tomoscintigraphy is evaluating
Time frame: 24 hours
The concordance between the morphological abnormalities visualized at the thoracic angioscanner (visualization of an endoluminal defect within the pulmonary arterial network) is evaluated.
Time frame: 24 hours
The concordance between the morphological abnormalities on CTPA (visualization of an endoluminal defect within the pulmonary arterial network) is evaluated.
Time frame: 24 hours
The interobserver reproducibility of subtraction technique versus pulmonary tomoscintigraphy in reported as normal or abnormal lung perfusion at a segmental level.
University Hospital, Brest
Other
Pulmonary Perfusion by Iodine Subtraction Mapping CT Angiography in Acute Pulmonary Embolism: a Diagnostic Accuracy Study Versus Pulmonary Perfusion SPECT.
Acronym: PASEP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06015529
Cardiovascular Diseases, Embolism
Brussels, Belgium
View Trial DetailsNCT04014972
Acute Aortic Syndrome, Aneurysm
View Trial DetailsNCT07689136
Cardiovascular Diseases, Deep Vein Thrombosis
Tunis, Tunisia
View Trial DetailsNCT06183944
Cardiovascular Diseases, Embolism
Toulon, France
View Trial Details