Informations générales (source: ClinicalTrials.gov)
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) (PRONOSPECT)
Interventional
N/A
University Hospital, Brest (Voir sur ClinicalTrials)
juin 2024
mars 2029
02 novembre 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bicêtre | David MONTANI, Pr | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Louis Mourier | Isabelle MAHE, Pr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH Les Sables d'Olonne - 85340 - Les Sables-d'Olonne - France | Nicolas BREBION | Contact (sur clinicalTrials) | |||
| CH Quimper - 29000 - Quimper - France | Charles ORIONE, Dr | Contact (sur clinicalTrials) | |||
| CHD Vendée - La Roche sur Yon - 85925 - La Roche-sur-Yon - France | Jean-Manuel KUBINA, Dr | Contact (sur clinicalTrials) | |||
| CHIC Toulon - 83056 - Toulon - France | Jean-Noël POGGI, Dr | Contact (sur clinicalTrials) | |||
| CHU Amiens - 80054 - Amiens - France | Contact (sur clinicalTrials) | ||||
| CHU Angers - 49933 - Angers - France | Jeanne HERSANT, Pr | Contact (sur clinicalTrials) | |||
| CHU Brest - 29609 - Brest - France | Pierre-Yves LE ROUX, Pr | Contact (sur clinicalTrials) | |||
| CHU St-Etienne - 42055 - Saint-Étienne - France | Laurent BERTOLETTI, Pr | Contact (sur clinicalTrials) | |||
| CHU Toulouse - 31059 - Toulouse - France | Alessandra BURA-RIVIERE, Pr | Contact (sur clinicalTrials) | |||
| Hegp Ap-Hp - 75015 - Paris - France | Olivier Sanchez, Pr | Contact (sur clinicalTrials) | |||
| HIA Toulon - 83800 - Toulon - France | Antoine-Raphaël BRONSTEIN, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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.
- 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.
- Unwilling or unable to give written informed consent (protected adults, under
tutorship or curatorship)
- Patients deprived of their liberty by a judicial or administrative decision,
patients undergoing psychiatric care by virtue of Articles L. 3212-1 and L. 3213-1
who are not covered by the provisions of Article L. 1121-8 and patients admitted to
a health or social establishment for purposes other than research
- No Social security affiliation
- Isolated DVT
- Pregnant women,parturients women
- Other indication for anticoagulant therapy (e.g. atrial fibrillation, mechanic
valve)
- Life expectancy < 6 months
- Any patients for whom there is a strong indication to treat longer than 6 months: PE
provoked by a major persistent factor (e.g. cancer) or Recurrent unprovoked PE
- PE provoked by a major transient risk factor