Status:
COMPLETED
Clinical Relevance of Thoracic Echography for the Early Diagnosis of Interstitial Lung Disease in Systemic Scleroderma - Pilot Study
Lead Sponsor:
University Hospital, Tours
Conditions:
Systemic Sclerosis
Eligibility:
All Genders
18-100 years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04725786
Start Date
March 17 2021
End Date
June 8 2022
Last Update
December 22 2025
Active Locations (1)
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1
CHRU Tours
Tours, France, 37044