Clinical Relevance of Thoracic Echography for the Early Diagnosis of Interstitial Lung Disease in Systemic Scleroderma - Pilot Study

NCT04725786 | Completed

• 2 other identifiers: DR200982020-A03249-30
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Diffuse interstitial lung disease (PID) is the leading cause of death in systemic scleroderma (SSc). Major progress has recently been made in its therapeutic management. Early diagnosis is essential to optimize this management. Current diagnostic techniques are based on high-resolution computed tomography on the thorax (HRCT) and pulmonary functional tests (PFT). However, these explorations have their limitations. Thus, there is a need for new techniques for a very early diagnosis of PID-SSc. Thoracic ultrasound (TUS) is an innovative, easily accessible, non-irradiating, inexpensive and painless tool. It is an emerging technique for the diagnosis of PID and has already proven its sensitivity for the detection of interstitial damage, as defined by HRCT. The main objective of the PRECOSS study is to describe the prevalence of an ultrasound interstitial syndrome in patients with SSc, free of PID-SSc (defined by the Goh criteria) detectable by HRCT.

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• Presence of interstitial syndrome on echography

  Interstitial syndrome is defined by the total number of B lines is greather than or equal to 10 and/or the average thickness of the pleural line is greater than 3 mm on at least one test site and/or the irregularity score of the pleural line is greater than 16%

  At baseline

Secondary Outcomes (15)

• Ventilatory mechanics

  At Baseline

• Ventilatory mechanics

  At Baseline

• Ventilatory mechanics

  At Baseline

• Ventilatory mechanics

  At Baseline

• Pulmonary gas exchange

  At Baseline

Other Outcomes (1)

• Nailfold capillaroscopy

  At baseline

Study Arms (1)

Case group

EXPERIMENTAL

The intervention of the research corresponds to the realization of a thoracic echography.

Other: thoracic echography

Interventions

thoracic echography OTHER

The research intervention corresponds to the performance of a thoracic echography to diagnose an incipient pulmonary interstitial syndrome.

Case group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Diagnosis of systemic scleroderma according to EULAR/ACR 2013 criteria
• Forced vital capacity ≥ 80% of the value predicted on the last respiratory function test performed.
• Carbon monoxide diffusion capacity corrected for hemoglobinemia ≥ 70% of the value predicted on the last respiratory function test performed.
• Patient capable of performing functional exploration during the year
• Affiliation to a social security system
• Patient who has given free and informed consent

You may not qualify if:

• Any other connectivity associated to systemic sleroderma
• Any chronic pathologies, co-morbidities, history judged by the investigator as being likely to lead to complications for the patient and/or which may impact the results of functional exploration during exercise.
• All known fibrotic and/or obstructive respiratory pathologies.
• Presence of echocardiographic signs of pulmonary arterial hypertension according to 2015 criteria
• Diagnosis of left heart disease
• Cumulative smoking \> 10 packs.years
• Pregnant or breastfeeding woman
• Refusal to participate in the study
• Refusal to use the data
• Adults under legal protection (temporary protection measure, curatorship, guardianship)

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

CHRU Tours

Tours, 37044, France

Location

Related Publications (1)

• Mercier C, Thoreau B, Flament T, Legue S, Pearson A, Jobard S, Marchand-Adam S, Plantier L, Diot E. High Prevalence of the Lung Ultrasound Interstitial Syndrome in Systemic Sclerosis Patients with Normal HRCT and Lung Function-A Pilot Study. J Clin Med. 2024 May 14;13(10):2885. doi: 10.3390/jcm13102885.

  PMID: 38792426 RESULT

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 27, 2021
• Study Start: March 17, 2021
• Primary Completion: June 8, 2022
• Study Completion: June 8, 2022
• Last Updated: December 22, 2025

Record last verified: 2022-06

Locations

FR (1)