Using advanced imaging to predict the risk of blood clot recurrence in pulmonary embolism patients

Residual Pulmonary Vascular Obstruction (RPVO) Index Computed with Ventilation/perfusion SPECT/CT Imaging to Predict the Risk of Venous Thromboembolism (VTE) Recurrence in Patients with Pulmonary Embolism (PE)

This study is testing if advanced imaging can help find out which patients with a history of pulmonary embolism are at risk for blood clots coming back, so they can get the right treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 665 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Brest (other)
• Locations: 13 sites (Amiens, France and 12 other locations)
• Trial ID: NCT06372730 on ClinicalTrials.gov

What this trial studies

This study aims to identify the risk of venous thromboembolism recurrence in patients who have experienced a pulmonary embolism (PE) by utilizing Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT) imaging. It focuses on patients classified as having an intermediate risk of recurrence, a group that has been less studied. By assessing residual pulmonary vascular obstruction (RPVO) through advanced imaging techniques, the study seeks to better stratify patients and determine who may benefit from prolonged anticoagulation therapy. The goal is to improve patient outcomes by identifying those at higher risk for recurrence who may require ongoing treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced an objectively proven pulmonary embolism and have completed an initial course of anticoagulant therapy.

Not a fit: Patients who may not benefit from this study include those with isolated deep vein thrombosis, pregnant women, or individuals with a life expectancy of less than six months.

Why it matters

Potential benefit: If successful, this study could lead to more personalized treatment plans for patients at risk of recurrent pulmonary embolism, potentially reducing fatal outcomes.

How similar studies have performed: While studies have explored the relationship between RPVO and recurrence risk in high-risk patients, this approach focusing on the intermediate risk group is relatively novel.

Eligibility criteria

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,parturients women
* 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) or Recurrent unprovoked PE
* PE provoked by a major transient risk factor

Where this trial is running

Amiens, France and 12 other locations

• CHU Amiens — Amiens, France, France (ACTIVE_NOT_RECRUITING)
• CHU Angers — Angers, France, France (NOT_YET_RECRUITING)
• CHU Brest — Brest, France, France (RECRUITING)
• Hôpital Louis MourierAP-HP — Colombes, France, France (NOT_YET_RECRUITING)
• CHD Vendée - La Roche sur Yon — La Roche-sur-Yon, France, France (RECRUITING)
• Kremlin-Bicêtre AP-HP — Le Kremlin-Bicêtre, France, France (NOT_YET_RECRUITING)
• CH Les Sables d'Olonne — Les Sables-d'Olonne, France, France (NOT_YET_RECRUITING)
• Hegp Ap-Hp — Paris, France, France (NOT_YET_RECRUITING)
• CH Quimper — Quimper, France, France (RECRUITING)
• CHU St-Etienne — Saint-Etienne, France, France (NOT_YET_RECRUITING)
• CHIC Toulon — Toulon, France, France (NOT_YET_RECRUITING)
• HIA Toulon — Toulon, France, France (NOT_YET_RECRUITING)
• CHU Toulouse — Toulouse, France, France (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Pierre-Yves LE ROUX, Pr

Conditions: Pulmonary Embolism, Venous Thromboembolism, venous thromboembolism recurrence