Clinical Trials Directory

Trials / Completed

CompletedNCT03579849

Pulmonary Perfusion by Iodine Subtraction Mapping CT Angiography in Acute Pulmonary Embolism

Pulmonary Perfusion by Iodine Subtraction Mapping CT Angiography in Acute Pulmonary Embolism: a Diagnostic Accuracy Study Versus Pulmonary Perfusion SPECT.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
University Hospital, Brest · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

* 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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTPulmonary tomoscintigraphyThe 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.

Timeline

Start date
2018-06-25
Primary completion
2019-04-24
Completion
2019-04-25
First posted
2018-07-09
Last updated
2025-12-03

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03579849. Inclusion in this directory is not an endorsement.