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)

Launched by UNIVERSITY HOSPITAL, BREST · Apr 15, 2024

Keywords

ClinConnect Summary

The PRONOSPECT trial is studying how a specific imaging technique called Ventilation/Perfusion SPECT/CT can help predict the risk of recurring blood clots in patients who have experienced a pulmonary embolism (PE). A pulmonary embolism occurs when a blood clot blocks blood flow to the lungs, and while some patients are at very low risk for recurrence, others fall into an intermediate risk category that is not well understood. This study aims to see if measuring something called residual pulmonary vascular obstruction (RPVO) using this advanced imaging can provide better insights into who might be at risk for getting another PE.

To be eligible for this study, participants must be at least 18 years old, have had a confirmed PE, and have received anticoagulant treatment for 3 to 6 months, with plans to stop that treatment. Participants will undergo the V/Q SPECT/CT imaging, which offers a more detailed view of their lungs compared to traditional methods, to help researchers understand the relationship between RPVO and the risk of recurrence. This trial is currently recruiting participants, and it is important for potential volunteers to know that there are specific conditions that may exclude them, such as certain medical issues or if they are pregnant.

Gender

ALL

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