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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)

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Brest
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In plain words

What the trial is, and whether it could suit you

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 intermediat

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📋 Eligibility rules (as published)
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. Exclusion Criteria: * 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 and parturients * 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) * Recurrent unprovoked PE PE provoked by a major transient risk factor (e.g. surgery with general anesthesia for greater than 30 min, confined to bed in hospital for at least 3 days with an acute illness, cesarean section) AND none of the following persistent factors : * BMI ≥ 30 * Chronic respiratory disease * Chronic inflammatory disease (e.g., ulcerative colitis, rheumatoid arthritis, etc.) * Hepatocellular insufficiency * Renal insufficiency with creatinine clearance \< 60 mL/min * Chronic or persistent immobilization
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What it tests

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

13 sites
CHU Amiens
Amiens, France
CHU Angers
Angers, France
CHU Brest
Brest, France
Hôpital Louis MourierAP-HP
Colombes, France
CHD Vendée - La Roche sur Yon
La Roche-sur-Yon, France
Kremlin-Bicêtre AP-HP
Le Kremlin-Bicêtre, France
CH Les Sables d'Olonne
Les Sables-d'Olonne, France
Hegp Ap-Hp
Paris, France

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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