Contribution of Lower Limb Venous Colour Doppler Ultrasound in the Diagnosis of Pulmonary Embolism Recurrence

Study Overview
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Brief Summary
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Venous thromboembolic disease is a clinical entity including pulmonary embolism (PE) and deep vein thrombosis (DVT). It is a chronic disease with 30% recurrence rate at 10 years. In patients with recurrent PE clinical suspicion, an objective and accurate diagnostic method/strategy is warranted to exclude or confirm a PE new episode diagnosis and to decide on treatment initiation. Recurrent PE diagnosis raises several issues related to the limitations of clinical scores, D-dimer testing, and diagnostic imaging used for a first episode diagnosis. Most importantly, residual obstruction on chest imaging reported in more than 50% of cases at 6 months can make it difficult to distinguish between an old and a new thrombosis in the absence of possible comparison with a previous imaging carried out under the same modalities. There are currently few recommendations about the diagnostic strategy for patients with a recurrent PE clinical suspicion and these recommendations are not very consistent due to the lack of a validated strategy. None of current guidelines have included imaging-detectable lower-limb DVT within the strategies despite a reported high prevalence of PE-associated DVT. In one study using venography, 82% (95% CI 76.5 - 86.9) of angiographically-proven PE patients had an associated proximal or distal deep vein thrombosis, of which 42% were asymptomatic. In another study using lower-limb venous ultrasound, a proximal or distal DVT was detected in 93% (95% CI 85-97) of patients with PE.

Detailed Description
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In this study, patients with PE clinical suspicion and a previous PE episode have a standard diagnostic work-up based on clinical probability assessment, D-dimer testing and diagnostic imaging (pulmonary CT angiography, ventilation perfusion scan). A bilateral lower-limb venous colour doppler ultrasound (CDUS) is performed in parallel in these patients as usually carried out in our hospital for the diagnosis management of patients with clinically suspected PE. This test is performed and interpreted by an independent sonographer unaware of the results of the standard diagnostic work-up. Lower-limb venous CDUS is then compared to the results of the standard work-up as interpreted during expert panel meetings by members involved in the diagnosis and management of patients with PE and DVT. Data will be collected both retrospectively and prospectively.

Official Title
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Contribution of Lower Limb Venous Colour Doppler Ultrasound in the Diagnosis of Pulmonary Embolism Recurrence

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Other: Color Doppler Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult consecutive patients (>= 18 years old) Hospitalized for clinical suspicion of pulmonary embolism recurrence with at least one of the following symptoms: acute dyspnea or worsening of chronic dyspnea, chest pain, hemoptysis or syncope Exclusion Criteria: Time between onset of symptoms and diagnosis > 15 days Pregnant women Contra-indication to CT pulmonary angiography Lower-limb CDUS not possible to perform for technical reasons Lung scans not possible to perform for technical reasons

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult patients hospitalized for suspicion of pulmonary embolism recurrence<br>Patients with at least one of the following symptoms: acute dyspnea or aggravation of chronic dyspnea, chest pain, hemoptysis or syncope | Other: Color Doppler Ultrasound<br>* Comparison with conventional diagnosis strategy including a clinical probability score, D-dimers and chest imaging.<br>* Other names: Diagnosis strategy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate lower-limb venous Color Doppler Ultrasound (CDUS) contribution to the conventional strategy used for pulmonary embolism recurrence diagnosis including a clinical probability score, D-dimers and chest imaging. | Proportion of patients for whom the lower-limb venous CDUS is positive. CDUS will be considered as positive if an acute DVT is shown with any of the following aspects: Mobile thrombus Completely occlusive thrombus Sub-occlusive thrombus without deep venous reflux Color Doppler Ultrasound will be considered as negative for a new thrombosis if the vein is compressible and there is no image of DVT, or if there are images of DVT sequelae only, with one of the following aspects: Parietal residual sequelae Partial obstruction with deep venous reflux | At diagnostic work-up (24 first hours following admission) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare demographic characteristics between groups of patients with and without a new episode of PE based on expert panel decision and lower limbs CDUS results. | Statistical analysis of the following characteristics based on demographic variables usually collected in our hospital during patient management : Age, gender, height, weight, BMI. | At diagnostic work-up (24 first hours following admission) | 
| To compare clinical characteristics between groups of patients with and without a new episode of PE based on expert panel decision and lower limbs CDUS results. | Statistical analysis of the following characteristics based on clinical variables usually collected in our hospital during patient management : Vital signs: temperature, systolic blood pressure, diastolic blood pressure, heart rate, peripheral oxygen saturation (%) Clinical scores: diagnostic (Wells score), prognostic (sPESI, ESC) Symptoms: dyspnea, chest pain, malaise, hemoptysis, lower limb edema, lower limb redness, lower limb pain History of venous thromboembolic disease (details) Context: presence or absence of risk factors for venous thromboembolic disease Comorbidities: chronic respiratory failure, chronic heart failure, hemorrhagic or ischemic stroke, hypertension, dyslipidemia, smoking, cancer Treatment: antiplatelet, anticoagulant, anti-inflammatory, hormonal treatment, chemotherapy | At diagnostic work-up (24 first hours following admission) | 
| To compare biological characteristics between groups of patients with and without a new episode of PE based on expert panel decision and lower limbs CDUS results. | Statistical analysis of the following characteristics based on blood tests usually performed in our hospital during patient management : Hemoglobin, neutrophil/lymphocyte ratio, D-dimer Creatinine clearance expressed as Cockcroft and Gault (mL/min), CRP (mg/L) NT-proBNP, troponin, fibrinogen | At diagnostic work-up (24 first hours following admission) | 
| To compare imaging characteristics between groups of patients with and without a new episode of PE based on expert panel decision and lower limbs CDUS results. | Statistical analysis of the following characteristics based on imaging tests usually performed in our hospital during patient management : CT pulmonary angiography Ventilation-perfusion scan Venous CDUS | At diagnostic work-up (24 first hours following admission) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary embolism, Deep vein thrombosis, Recurrence, Diagnosis strategy, Colour Doppler ultrasound