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

Systemic Sclerosis Clinical Trial

— PRECOSS  

Official title:

Pertinence Clinique de l'échographie Thoracique Pour le Diagnostic précoce de la Pneumopathie Interstitielle Diffuse de la sclérodermie systémique - Etude Pilote

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04725786
• Other study ID #: DR20098
• Secondary ID: 2020-A03249-30
• Status: Completed
• Phase: N/A
• Start date: March 17, 2021
• Est. completion date: June 8, 2022

Study information

• Verified date: June 2022
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 8, 2022
• Est. primary completion date: June 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age = 18 years old

• Diagnosis of systemic scleroderma according to EULAR/ACR 2013 criteria

• Absence of diffuse interstitial lung disease proven by scanner on the day of inclusion

• 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

Exclusion Criteria:

• 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

• Infectious pneumonia within 90 days prior to inclusion

• Acute respiratory illness requiring hospitalization within one year prior to inclusion

• Pregnant or breastfeeding woman

• Refusal to participate in the study

• Refusal to use the data

• Adults under legal protection (temporary protection measure, curatorship, guardianship)

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Systemic Sclerosis

Intervention

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

Locations

Country	Name	City	State
France	CHRU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nailfold capillaroscopy	Classification of Cutulo	At baseline
Primary	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	Ventilatory mechanics	Measured by spirometry	At Baseline
Secondary	Ventilatory mechanics	Measured by plethysmography	At Baseline
Secondary	Ventilatory mechanics	Measured by impulse oscillometry	At Baseline
Secondary	Ventilatory mechanics	Measured by cardiopulmonary exercise testing	At Baseline
Secondary	Pulmonary gas exchange	Measured by cardiopulmonary exercise testing	At Baseline
Secondary	Pulmonary gas exchange	Measured by Diffusing capacity for carbon monoxide	At baseline
Secondary	Pulmonary gas exchange	Measured by 6-minute walk test	At baseline
Secondary	Exercise capacity	Measured by cardiopulmonary exercise testing	At baseline
Secondary	Circulatory response	Measured by cardiopulmonary exercise testing	At baseline
Secondary	Dyspnoea	Measured by cardiopulmonary exercise testing	At baseline
Secondary	Dyspnoea	Assessed by Dyspnea12	At baseline
Secondary	Dyspnoea	Assessed by Modified Medical Research Council (mMRC) Scale	At baseline
Secondary	Assessment of Quality of life	Assessed by Cochin 17-item Scleroderma Functional Scale	At baseline
Secondary	Assessment of Quality of life	Assessed by Saint George's Respiratory Questionnaire (SGRQ)	At baseline
Secondary	Cough	Evaluation by Leicester Cough Questionnaire - French translation	At baseline