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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A03249-30 | Registry Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group | Experimental | The intervention of the research corresponds to the realization of a thoracic echography. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thoracic echography | Other | The research intervention corresponds to the performance of a thoracic echography to diagnose an incipient pulmonary interstitial syndrome. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilatory mechanics | Measured by spirometry | At Baseline |
| Ventilatory mechanics | Measured by plethysmography | At Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Nailfold capillaroscopy | Classification of Cutulo | At baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Tours | Tours | 37044 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38792426 | Result | 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. |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| Ventilatory mechanics | Measured by impulse oscillometry | At Baseline |
| Ventilatory mechanics | Measured by cardiopulmonary exercise testing | At Baseline |
| Pulmonary gas exchange | Measured by cardiopulmonary exercise testing | At Baseline |
| Pulmonary gas exchange | Measured by Diffusing capacity for carbon monoxide | At baseline |
| Pulmonary gas exchange | Measured by 6-minute walk test | At baseline |
| Exercise capacity | Measured by cardiopulmonary exercise testing | At baseline |
| Circulatory response | Measured by cardiopulmonary exercise testing | At baseline |
| Dyspnoea | Measured by cardiopulmonary exercise testing | At baseline |
| Dyspnoea | Assessed by Dyspnea12 | At baseline |
| Dyspnoea | Assessed by Modified Medical Research Council (mMRC) Scale | At baseline |
| Assessment of Quality of life | Assessed by Cochin 17-item Scleroderma Functional Scale | At baseline |
| Assessment of Quality of life | Assessed by Saint George's Respiratory Questionnaire (SGRQ) | At baseline |
| Cough | Evaluation by Leicester Cough Questionnaire - French translation | At baseline |