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)

Last updated: October 30, 2024
Sponsor: University Hospital, Brest
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Injury

Claudication

Venous Thromboembolism

Treatment

Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT)

Clinical Study ID

NCT06372730
29BRC23.0161
2023-A01566-39
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients ≥ 18 years,

  • who experienced an objectively proven PE,

  • who have been treated initially with anticoagulant therapy for 3 to 6 uninterruptedmonths (180 - 210 days) and for whom anticoagulation will not be prolonged.

Exclusion

Exclusion Criteria:

  • Unwilling or unable to give written informed consent (protected adults, undertutorship 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. 3213-1who are not covered by the provisions of Article L. 1121-8 and patients admitted toa 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, mechanicvalve)

  • Life expectancy < 6 months

  • Any patients for whom there is a strong indication to treat longer than 6 months: PEprovoked by a major persistent factor (e.g. cancer) or Recurrent unprovoked PE

  • PE provoked by a major transient risk factor

Study Design

Total Participants: 665
Treatment Group(s): 1
Primary Treatment: Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT)
Phase:
Study Start date:
June 11, 2024
Estimated Completion Date:
March 31, 2029

Connect with a study center

  • CHU Amiens

    Amiens, 80054
    France

    Site Not Available

  • CHU Angers

    Angers, 49933
    France

    Site Not Available

  • CHU Brest

    Brest, 29609
    France

    Active - Recruiting

  • Hôpital Louis MourierAP-HP

    Colombes, 92700
    France

    Site Not Available

  • CHD Vendée - La Roche sur Yon

    La Roche-sur-Yon, 85925
    France

    Active - Recruiting

  • Kremlin-Bicêtre AP-HP

    Le Kremlin-Bicêtre, 94270
    France

    Site Not Available

  • CH Les Sables d'Olonne

    Les Sables-d'Olonne, 85340
    France

    Site Not Available

  • Hegp Ap-Hp

    Paris, 75015
    France

    Site Not Available

  • CH Quimper

    Quimper, 29000
    France

    Active - Recruiting

  • CHU St-Etienne

    Saint-Étienne, 42055
    France

    Site Not Available

  • CHIC Toulon

    Toulon, 83056
    France

    Site Not Available

  • HIA Toulon

    Toulon, 83800
    France

    Site Not Available

  • CHU Toulouse

    Toulouse, 31059
    France

    Site Not Available

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