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

NCT05413317 | Completed

• 1 other identifier: 2021-CHITS-012
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pulmonary Embolism

Keywords

Pulmonary embolism; Deep vein thrombosis; Recurrence; Diagnosis strategy; Colour Doppler ultrasound

Outcome Measures

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.

  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 Outcomes (4)

• 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.

  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.

  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.

  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.

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

Study Arms (1)

Adult patients hospitalized for suspicion of pulmonary embolism recurrence

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

Interventions

Color Doppler Ultrasound OTHER

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

Also known as: Diagnosis strategy

Adult patients hospitalized for suspicion of pulmonary embolism recurrence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients hospitalized for suspicion of pulmonary embolism recurrence

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (1)

CHITS

Toulon, Var, 83056, France

Location

Related Publications (9)

• 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.

  PMID: 26780736 BACKGROUND

• 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.

  PMID: 32915980 BACKGROUND

• 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.

  PMID: 16424432 BACKGROUND

• 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.

  PMID: 28197219 BACKGROUND

• 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.

  PMID: 31280989 BACKGROUND

• 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.

  PMID: 30482764 BACKGROUND

• 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.

  PMID: 23682905 BACKGROUND

• 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.

  PMID: 10531151 BACKGROUND

• 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.

  PMID: 14691585 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thrombosis; Recurrence

Condition Hierarchy (Ancestors)

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

Study Officials

• Marie ELIAS, MD

  Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 10, 2022
• Study Start: March 4, 2022
• Primary Completion: November 4, 2023
• Study Completion: November 4, 2023
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)