Actively Recruiting
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)
Led by University Hospital, Brest · Updated on 2024-11-01
665
Participants Needed
13
Research Sites
246 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older
- Experienced an objectively confirmed pulmonary embolism
- Treated with anticoagulants for 3 to 6 uninterrupted months (180-210 days)
- Anticoagulation will not be continued beyond this period
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Under legal protection or psychiatric care preventing consent
- Deprived of liberty by judicial or administrative decision
- No social security coverage
- Isolated deep vein thrombosis without PE
- Pregnant or recently gave birth
- Other reasons for anticoagulant therapy (e.g., atrial fibrillation, mechanical valve)
- Life expectancy less than 6 months
- Strong indication for anticoagulation longer than 6 months (e.g., cancer, recurrent unprovoked PE)
- PE caused by major transient risk factors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
CHU Amiens
Amiens, France, France, 80054
Active, Not Recruiting
2
CHU Angers
Angers, France, France, 49933
Not Yet Recruiting
3
CHU Brest
Brest, France, France, 29609
Actively Recruiting
4
Hôpital Louis MourierAP-HP
Colombes, France, France, 92700
Not Yet Recruiting
5
CHD Vendée - La Roche sur Yon
La Roche-sur-Yon, France, France, 85925
Actively Recruiting
6
Kremlin-Bicêtre AP-HP
Le Kremlin-Bicêtre, France, France, 94270
Not Yet Recruiting
7
CH Les Sables d'Olonne
Les Sables-d'Olonne, France, France, 85340
Not Yet Recruiting
8
Hegp Ap-Hp
Paris, France, France, 75015
Not Yet Recruiting
9
CH Quimper
Quimper, France, France, 29000
Actively Recruiting
10
CHU St-Etienne
Saint-Etienne, France, France, 42055
Not Yet Recruiting
11
CHIC Toulon
Toulon, France, France, 83056
Not Yet Recruiting
12
HIA Toulon
Toulon, France, France, 83800
Not Yet Recruiting
13
CHU Toulouse
Toulouse, France, France, 31059
Not Yet Recruiting
Research Team
P
Pierre-Yves LE ROUX, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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