Residual Pulmonary Vascular Obstruction (RPVO) Index Computed with Ventilation/perfusion SPECT/CT Imaging to Predict the Risk of Venous Thromboembolism (VTE) Recurrence in Patients with Pulmonary Embolism (PE)

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Major risk after pulmonary embolism (PE) is recurrence, fatal in 10% of patients. Patients with PE can be stratified in 3 groups according to the risk of recurrence : very low risk, high risk or Intermediate risk. Little is known about this last group. Anticoagulation is efficient to prevent recurrence but is currently not recommended for patient with an intermediate risk of recurrence. Identifying risk factors of recurrent PE remains a major issue to identify sub-groups of patients who would require lifelong anticoagulation. In 30-40% of cases, PE patients develop residual pulmonary vascular obstruction (RPVO), which has been found to be associated with an increased recurrence risk. This last observation was mostly reported in patients with unprovoked PE (patients with high risk of recurrence) and RPVO was measured using conventional planar lung scan. In patients with an intermediate risk of recurrence, the impact of RPVO has been much less studied. In addition, the definition of RPVO was variable according to studies and correlation between RPVO burden and recurrence risk has not been clearly demonstrated. This might be explained by the inherent limitation of RPVO quantification using conventional planar imaging, which is only based on a visual estimation on 2-dimensional images. Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT) is a new method of scintigraphic image acquisition that offers the advantage of 3-dimensional imaging, enabling more accurate and reproducible quantification of RPVO. The main hypothesis of this study is that in patients with PE at intermediate risk of recurrence, RPVO computed with V/Q SPECT/CT imaging may be an important predictor of recurrence.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients ≥ 18 years,

• who experienced an objectively proven PE,

• who have been treated initially with anticoagulant therapy for 3 to 6 uninterrupted months (180 - 210 days) and for whom anticoagulation will not be prolonged.

Locations
Other Locations
France
CHU Amiens
ACTIVE_NOT_RECRUITING
Amiens
CHU Angers
NOT_YET_RECRUITING
Angers
CHU Brest
RECRUITING
Brest
Hôpital Louis MourierAP-HP
NOT_YET_RECRUITING
Colombes
CHD Vendée - La Roche sur Yon
RECRUITING
La Roche-sur-yon
Kremlin-Bicêtre AP-HP
NOT_YET_RECRUITING
Le Kremlin-bicêtre
CH Les Sables d'Olonne
NOT_YET_RECRUITING
Les Sables-d'olonne
Hegp Ap-Hp
NOT_YET_RECRUITING
Paris
CH Quimper
RECRUITING
Quimper
CHU St-Etienne
NOT_YET_RECRUITING
Saint-etienne
CHIC Toulon
NOT_YET_RECRUITING
Toulon
HIA Toulon
NOT_YET_RECRUITING
Toulon
CHU Toulouse
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Pierre-Yves LE ROUX, Pr
pierre-yves.leroux@chu-brest.fr
+33298223327
Time Frame
Start Date: 2024-06-11
Estimated Completion Date: 2029-03
Participants
Target number of participants: 665
Treatments
Experimental: Patients with PE who have been treated with anticoagulant therapy for 3 to 6 uninterrupted months
Patients who experienced an objectively proven PE who have been treated initially with anticoagulant therapy for 3 to 6 uninterrupted months (180 - 210 days) and for whom anticoagulation will not be prolonged.
Sponsors
Leads: University Hospital, Brest

This content was sourced from clinicaltrials.gov