Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06372730

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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