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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)

NCT06372730 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 665

Last updated 2024-11-01

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • University Hospital, Brest

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-11
Primary Completion
2028-12-31
Completion
2029-03-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06372730 on ClinicalTrials.gov