protocolSection identificationModule nctId: NCT06372730, orgStudyIdInfo id: 29BRC23.0161, secondaryIdInfos id: 2023-A01566-39, type: OTHER, domain: IDRCB, briefTitle: 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), acronym: PRONOSPECT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-10, completionDateStruct date: 2029-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University Hospital, Brest, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Pulmonary Embolism, conditions: Venous Thromboembolism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Cohort study, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 665, type: ESTIMATED, armsInterventionsModule interventions name: Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT), outcomesModule primaryOutcomes measure: Symptomatic recurrent venous thromboembolism (VTE), including objectively confirmed nonfatal symptomatic PE or proximal deep vein thrombosis or fatal PE during a 24-month follow-up after inclusion in the study, secondaryOutcomes measure: Adjudicated symptomatic objectively confirmed recurrent VTE during the follow-up period., secondaryOutcomes measure: Percentage of patients with RPVO (as defined by a perfusion defect > 5%) on V/Q SPECT/CT imaging at inclusion in the study., secondaryOutcomes measure: Different cut-offs of pulmonary vascular obstruction index will be evaluated to predict the risk of VTE recurrence at 2 years, by generating ROC curves, secondaryOutcomes measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: age, secondaryOutcomes measure: The following score will be computed : HERDOO2 (Hyperpigmentation, Edema, Redness, D-Dimer, Obesity, Old), secondaryOutcomes measure: Potential predictors of RPVO including : demographics, secondaryOutcomes measure: Symptomatic recurrent VTE during a 3 Months follow-up period in patients with suspicion of PE recurrence who has been left untreated based on a negative V/Q SPECT/CT scan, secondaryOutcomes measure: Dyspnea index will be assessed using mMRC scale (Modified Medical Research Council), secondaryOutcomes measure: Quality of life (QoL) will be assessed using PEmb-Qol (Pulmonary Embolism Quality of Life), secondaryOutcomes measure: Number of Participants with chronic thromboembolic pulmonary hypertension (CTEPH)., secondaryOutcomes measure: Mortality of all causes., secondaryOutcomes measure: Percentage of patients with RPVO (> 5%) on V/Q SPECT/CT imaging using Technegas and Krypton., secondaryOutcomes measure: The following score will be computed : PADIS-PE score., secondaryOutcomes measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: gender, secondaryOutcomes measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: obesity, secondaryOutcomes measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: D-Dimer, secondaryOutcomes measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: inherited or acquired thrombophilia, secondaryOutcomes measure: Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: residual vein thrombosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Amiens, city: Amiens, zip: 80054, country: France, contacts name: Marie-Antoinette SEVESTRE, Pr, role: CONTACT, phone: +33322087306, email: sevestre.marie-antoinette@chu-amiens.fr, geoPoint lat: 49.9, lon: 2.3, locations facility: CHU Angers, city: Angers, zip: 49933, country: France, contacts name: Jeanne HERSANT, Pr, role: CONTACT, phone: +33661392285, email: Jeanne.hersant@chu-angers.fr, geoPoint lat: 47.46667, lon: -0.55, locations facility: CHU Brest, city: Brest, zip: 29609, country: France, contacts name: Pierre-Yves LE ROUX, Pr, role: CONTACT, phone: +33298223327, email: pierre-yves.leroux@chu-brest.fr, contacts name: Francis COUTURAUD, Pr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.3903, lon: -4.48628, locations facility: Hôpital Louis MourierAP-HP, city: Colombes, zip: 92700, country: France, contacts name: Isabelle MAHE, Pr, role: CONTACT, phone: +33147606490, email: isabelle.mahe@lmr.aphp.fr, geoPoint lat: 48.91882, lon: 2.25404, locations facility: CHD Vendée - La Roche sur Yon, city: La Roche-sur-Yon, zip: 85925, country: France, contacts name: Jean-Manuel KUBINA, Dr, role: CONTACT, phone: +33251446301, email: jean-manuel.kubina@ght85.fr, geoPoint lat: 46.66667, lon: -1.43333, locations facility: Kremlin-Bicêtre AP-HP, city: Le Kremlin-Bicêtre, zip: 94270, country: France, contacts name: David MONTANI, Pr, role: CONTACT, phone: +33145217976, email: david.montani@aphp.fr, geoPoint lat: 48.81471, lon: 2.36073, locations facility: CH Les Sables d'Olonne, city: Les Sables-d'Olonne, zip: 85340, country: France, contacts name: Nicolas BREBION, role: CONTACT, phone: +33251218824, email: nicolas.brebion@ght85.fr, geoPoint lat: 46.5, lon: -1.78333, locations facility: Hegp Ap-Hp, city: Paris, zip: 75015, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CH Quimper, city: Quimper, zip: 29000, country: France, contacts name: Charles ORIONE, Dr, role: CONTACT, phone: +33298526096, email: charles.orione@ch-cornouaille.fr, geoPoint lat: 48.0, lon: -4.1, locations facility: CHU St-Etienne, city: Saint-Étienne, zip: 42055, country: France, contacts name: Laurent BERTOLETTI, Pr, role: CONTACT, phone: +33477127770, email: laurent.bertoletti@chu-st-etienne.fr, geoPoint lat: 45.43389, lon: 4.39, locations facility: CHIC Toulon, city: Toulon, zip: 83056, country: France, contacts name: Jean-Noël POGGI, Dr, role: CONTACT, phone: +33494145787, email: jean-noel.poggi@ch-toulon.fr, geoPoint lat: 43.12442, lon: 5.92836, locations facility: HIA Toulon, city: Toulon, zip: 83800, country: France, contacts name: Antoine-Raphaël BRONSTEIN, Dr, role: CONTACT, phone: +33483162553, email: antoine-raphael.bronstein@intradef.gouv.fr, geoPoint lat: 43.12442, lon: 5.92836, locations facility: CHU Toulouse, city: Toulouse, zip: 31059, country: France, contacts name: Alessandra BURA-RIVIERE, Pr, role: CONTACT, phone: +33561322438, email: bura-riviere.a@chu-toulouse.fr, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False