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)

Официальное название

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)

Обзор

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.

Вмешательства

• Другое Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT)
  All patients will undergo a V/Q SPECT/CT scan at inclusion.

Первичные конечные точки

• Symptomatic recurrent venous thromboembolism (VTE), including objectively confirmed nonfatal symptomatic PE or proximal deep vein thrombosis or fatal PE during a 24-month follow-up after inclusion in the study [Срок оценки: From baseline to Month 24]

Вторичные конечные точки (12)

• Adjudicated symptomatic objectively confirmed recurrent VTE during the follow-up period. [Срок оценки: From baseline to Month 24]
• Percentage of patients with RPVO (as defined by a perfusion defect > 5%) on V/Q SPECT/CT imaging at inclusion in the study. [Срок оценки: Inclusion]
• Different cut-offs of pulmonary vascular obstruction index will be evaluated to predict the risk of VTE recurrence at 2 years, by generating ROC curves [Срок оценки: Inclusion]
• Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: age [Срок оценки: Inclusion]
• The following score will be computed : HERDOO2 (Hyperpigmentation, Edema, Redness, D-Dimer, Obesity, Old) [Срок оценки: Inclusion]
• Potential predictors of RPVO including : demographics [Срок оценки: Inclusion]
• Symptomatic recurrent VTE during a 3 Months follow-up period in patients with suspicion of PE recurrence who has been left untreated based on a negative V/Q SPECT/CT scan [Срок оценки: 3 Months follow-up period after the suspicion of PE recurrence]
• Dyspnea index will be assessed using mMRC scale (Modified Medical Research Council) [Срок оценки: Inclusion and Month 6]
• Quality of life (QoL) will be assessed using PEmb-Qol (Pulmonary Embolism Quality of Life) [Срок оценки: Inclusion and Month 6]
• Number of Participants with chronic thromboembolic pulmonary hypertension (CTEPH). [Срок оценки: From baseline to Month 24]
• Mortality of all causes. [Срок оценки: From baseline to Month 24]
• Percentage of patients with RPVO (> 5%) on V/Q SPECT/CT imaging using Technegas and Krypton. [Срок оценки: Inclusion]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 13 центров

• CHU Amiens — Amiens
• CHU Angers — Angers
• CHU Brest — Brest
• Hôpital Louis MourierAP-HP — Colombes
• CHD Vendée - La Roche sur Yon — La Roche-sur-Yon
• Kremlin-Bicêtre AP-HP — Le Kremlin-Bicêtre
• CH Les Sables d'Olonne — Les Sables-d'Olonne
• Hegp Ap-Hp — Paris
• … и ещё 5 центров

Идентификаторы

NCT: NCT06372730 · 29BRC23.0161 · 2023-A01566-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗