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Pulmonary EmbolismRECHOPENCT05413317

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

An observational study of Pulmonary Embolism, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Embolism
What is being tested?
Color Doppler Ultrasound
How many people
115 participants
Where
1 siteFrance
Study dates
4 Mar 2022to 4 Nov 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients hospitalized for suspicion of pulmonary embolism recurrence

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHITS

    Toulon, Var, 83056

Other trials in France

About this study

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.

Read the detailed description

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.

Being tested
Color Doppler Ultrasound
Keywords
Pulmonary embolism, Deep vein thrombosis, Recurrence, Diagnosis strategy, Colour Doppler ultrasound
Medical subject headings
Pulmonary Embolism, Venous Thrombosis, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Color Doppler UltrasoundOther

    Also called Diagnosis strategy

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

Study groups in NCT05413317
Study groupRoleWhat they receive
Adult patients hospitalized for suspicion of pulmonary embolism recurrencePatients with at least one of the following symptoms: acute dyspnea or aggravation of chronic dyspnea, chest pain, hemoptysis or syncope
Receives: Other: Color Doppler Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    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

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

Secondary outcomes (4)
  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.

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

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

  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.

    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

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

  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.

    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

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

  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.

    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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2022
  2. Study start4 Mar 2022
  3. Primary completion4 Nov 2023
  4. Study completion4 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05413317
Sponsor's protocol ID
2021-CHITS-012
Acronym
RECHOPE
Status last verified
Jul 2026
First submitted
7 Jun 2022
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Heit JA, Spencer FA, White RH. The epidemiology of venous thromboembolism. J Thromb Thrombolysis. 2016 Jan;41(1):3-14. doi: 10.1007/s11239-015-1311-6.

    PubMed 26780736
  • Patel P, Patel P, Bhatt M, Braun C, Begum H, Wiercioch W, Varghese J, Wooldridge D, Alturkmani H, Thomas M, Baig M, Bahaj W, Khatib R, Kehar R, Ponnapureddy R, Sethi A, Mustafa A, Lim W, Le Gal G, Bates SM, Haramati LB, Kline J, Lang E, Righini M, Kalot MA, Husainat NM, Jabiri YNA, Schunemann HJ, Mustafa RA. Systematic review and meta-analysis of test accuracy for the diagnosis of suspected pulmonary embolism. Blood Adv. 2020 Sep 22;4(18):4296-4311. doi: 10.1182/bloodadvances.2019001052.

    PubMed 32915980
  • Nijkeuter M, Hovens MM, Davidson BL, Huisman MV. Resolution of thromboemboli in patients with acute pulmonary embolism: a systematic review. Chest. 2006 Jan;129(1):192-7. doi: 10.1378/chest.129.1.192.

    PubMed 16424432
  • Meysman M, Everaert H, Vincken W. Factors determining altered perfusion after acute pulmonary embolism assessed by quantified single-photon emission computed tomography-perfusion scan. Ann Thorac Med. 2017 Jan-Mar;12(1):30-35. doi: 10.4103/1817-1737.197772.

    PubMed 28197219
  • Sanchez O, Benhamou Y, Bertoletti L, Constans J, Couturaud F, Delluc A, Elias A, Fischer AM, Frappe P, Gendron N, Girard P, Godier A, Gut-Gobert C, Laporte S, Mahe I, Mauge L, Meneveau N, Meyer G, Mismetti P, Parent F, Pernod G, Quere I, Revel MP, Roy PM, Salaun PY, Smadja DM, Sevestre MA. [Recommendations for best practice in the management of venous thromboembolic disease in adults. Long version]. Rev Mal Respir. 2021 Apr;38 Suppl 1:e1-e6. doi: 10.1016/j.rmr.2019.05.038. Epub 2019 Jul 4. No abstract available. French.

    PubMed 31280989
  • Lim W, Le Gal G, Bates SM, Righini M, Haramati LB, Lang E, Kline JA, Chasteen S, Snyder M, Patel P, Bhatt M, Patel P, Braun C, Begum H, Wiercioch W, Schunemann HJ, Mustafa RA. American Society of Hematology 2018 guidelines for management of venous thromboembolism: diagnosis of venous thromboembolism. Blood Adv. 2018 Nov 27;2(22):3226-3256. doi: 10.1182/bloodadvances.2018024828.

    PubMed 30482764
  • Ageno W, Squizzato A, Wells PS, Buller HR, Johnson G. The diagnosis of symptomatic recurrent pulmonary embolism and deep vein thrombosis: guidance from the SSC of the ISTH. J Thromb Haemost. 2013 Aug;11(8):1597-602. doi: 10.1111/jth.12301. No abstract available.

    PubMed 23682905
  • Girard P, Musset D, Parent F, Maitre S, Phlippoteau C, Simonneau G. High prevalence of detectable deep venous thrombosis in patients with acute pulmonary embolism. Chest. 1999 Oct;116(4):903-8. doi: 10.1378/chest.116.4.903.

    PubMed 10531151
  • Elias A, Colombier D, Victor G, Elias M, Arnaud C, Juchet H, Ducasse JL, Didier A, Colin C, Rousseau H, Nguyen F, Joffre F. Diagnostic performance of complete lower limb venous ultrasound in patients with clinically suspected acute pulmonary embolism. Thromb Haemost. 2004 Jan;91(1):187-95. doi: 10.1160/TH03-05-0278.

    PubMed 14691585

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Embolism, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05413317, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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