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RECRUITING
NCT06372730
NA

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

Sponsor: University Hospital, Brest

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

665

Start Date

2024-06-11

Completion Date

2029-03

Last Updated

2024-11-01

Healthy Volunteers

No

Interventions

OTHER

Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT)

All patients will undergo a V/Q SPECT/CT scan at inclusion.

Locations (13)

CHU Amiens

Amiens, France, France

CHU Angers

Angers, France, France

CHU Brest

Brest, France, France

Hôpital Louis MourierAP-HP

Colombes, France, France

CHD Vendée - La Roche sur Yon

La Roche-sur-Yon, France, France

Kremlin-Bicêtre AP-HP

Le Kremlin-Bicêtre, France, France

CH Les Sables d'Olonne

Les Sables-d'Olonne, France, France

Hegp Ap-Hp

Paris, France, France

CH Quimper

Quimper, France, France

CHU St-Etienne

Saint-Etienne, France, France

CHIC Toulon

Toulon, France, France

HIA Toulon

Toulon, France, France

CHU Toulouse

Toulouse, France, France