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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 665
- 试验地点
- 26
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
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
时间窗: From baseline to Month 24
In case of a suspected VTE or death during follow-up, the study personnel will collect related clinical data on the electronic case report form, and prepare an adjudication file, including symptoms, clinical notes, hospital discharge summary, and results of all diagnostic tests. All suspicion of VTE recurrence will be adjudicated blindly by an independent central Clinical Events Committee. To assess the primary objective, RPVO will be defined by a perfusion mismatched defect of at least 5% of the whole lung, corresponding to a segmental defect. SPECT imaging should not be used at inclusion and should not result in proposing prolonged anticoagulation. SPECT images will be numerically stored and interpretation will be later performed independently by two nuclear medicine physicians who will be blinded to clinical history and the patient's outcome. Any difference in interpretation will be resolved by consensus.
次要结局
- Adjudicated symptomatic objectively confirmed recurrent VTE during the follow-up period.(From baseline to Month 24)
- 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(Inclusion)
- Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: age(Inclusion)
- Percentage of patients with RPVO (> 5%) on V/Q SPECT/CT imaging using Technegas and Krypton.(Inclusion)
- The following score will be computed : PADIS-PE score.(Inclusion)
- Percentage of patients with RPVO (as defined by a perfusion defect > 5%) on V/Q SPECT/CT imaging at inclusion in the study.(Inclusion)
- The following score will be computed : HERDOO2 (Hyperpigmentation, Edema, Redness, D-Dimer, Obesity, Old)(Inclusion)
- Potential predictors of RPVO including : demographics(Inclusion)
- Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: gender(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(3 Months follow-up period after the suspicion of PE recurrence)
- Quality of life (QoL) will be assessed using PEmb-Qol (Pulmonary Embolism Quality of Life)(Inclusion and Month 6)
- Number of Participants with chronic thromboembolic pulmonary hypertension (CTEPH).(From baseline to Month 24)
- Mortality of all causes.(From baseline to Month 24)
- Dyspnea index will be assessed using mMRC scale (Modified Medical Research Council)(Inclusion and Month 6)
- Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: obesity(Inclusion)
- Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: D-Dimer(Inclusion)
- Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: inherited or acquired thrombophilia(Inclusion)
- Other predictors of adjudicated symptomatic objectively confirmed recurrent VTE at 2 years including: residual vein thrombosis(Inclusion)