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Completed

NCT Number: NCT05413317

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

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.

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Key information

Conditions

Pulmonary Embolism Cardiovascular Diseases Disease Attributes Embolism Embolism and Thrombosis Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Respiratory Tract Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHITS

Toulon, Var, 83056, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Color Doppler Ultrasound

Other

Comparison with conventional diagnosis strategy including a clinical probability score, D-dimers and chest imaging.

Other names: Diagnosis strategy

Primary outcomes

  1. 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.

    Time frame: At diagnostic work-up (24 first hours following admission)

    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

Secondary outcomes

  1. 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.

    Time frame: At diagnostic work-up (24 first hours following admission)

    Statistical analysis of the following characteristics based on demographic variables usually collected in our hospital during patient management : Age, gender, height, weight, BMI.

  2. 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.

    Time frame: At diagnostic work-up (24 first hours following admission)

    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

  3. 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.

    Time frame: At diagnostic work-up (24 first hours following admission)

    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

  4. 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.

    Time frame: At diagnostic work-up (24 first hours following admission)

    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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Registry information

Acronym: RECHOPE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 10, 2022
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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