An interventional study of 7.0 T RMI in Systemic Sclerosis (SSc) and Magnetic Resonance Imaging (MRI), sponsored by Poitiers University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by Poitiers University Hospital · Not applicable, Interventional, and Screening
Systemic sclerosis (SSc) is a rare systemic autoimmune disease with specific osteoarticular pattern of unknown mechanism. Ischemic phenomenon have been suggested to participate to the osteoarticular involvement in SSc. To date, osteoarticular pattern and hand vascular involvement have been few studied in magnetic resonance imaging in SSc, and most often with low resolution RMI.
7 Tesla RMI allows high resolution for morphology examination, together with dynamic and functional vascular study and sodium articular concentration. Indeed, the aim of the study is to describe hand osteoarticular and vascular involvement in SSc, as well as sodium articular concentration. Clinico-biological association will be also assessed.
688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.
This study's enrollment of 50 is above the median of 34 across 493 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Poitiers University Hospital is the lead sponsor of 310 studies on the registry; 64 are open to participants now.
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Patients with SSc:
- ScS fulfilling ACR/EULAR 2013 classification criteria and followed in the department of internal medicine of Poitiers University Hospital, without clinical signs of digital arthrose
Control subjects:
- Hospitalized patients in the department of internal medicine of Poitiers University Hospital, without Raynaud's phenomenon, neither antecedent of inflammatory rheumatism and/or autoimmune disease, neither inflammatory articular symptoms during the previous month and no clinical signs of arthoses and/or arthritis at the inclusion in the study
For both:
Exclusion Criteria:
Patients with SSc:
- SSc associated with other define autoimmune disease (overlap syndrome)
For both:
Single 7.0 Tesla MRI of both hands for all the SSc and control subjects
Device: 7.0 T RMI
Single 7.0 Tesla MRI of both hands in the same time
Frequency of hand osteoarticular involvement in SSc and control subjects in 7.0 T RMI
Frequency of type and localisation of hand osteoarticular abnormality (erosions, bone oedema, synovitis, tenosynovitis, intraarticular swoilling) in 7.0 T RMI in patients with SSc and control subjects
Time frame: 7 days maximum (delay between realization of the RMI and its final interpretation)
Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI
Digital arteries count in both hand in 7.0 T RMI in SSc patients and control subjects
Time frame: 7 days maximum (delay between realization of the RMI and its final interpretation)
Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI
Lumen area of the selective section of the vessel (in mm2) in 7.0 T RMI in SSc patients and control subjects
Time frame: 7 days maximum (delay between realization of the RMI and its final interpretation)
Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI
Quality of arterial opacification in terms of percentage of digital artery that did not reach the first phalanx, in 7.0 T RMI in SSc patients and control subjects
Time frame: 7 days maximum (delay between realization of the RMI and its final interpretation)
Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI
Quality of venous return in terms of percentage of no visible venous return as far as the proximal phalanx in 7.0 T RMI in SSc patients and control subjects
Time frame: 7 days maximum (delay between realization of the RMI and its final interpretation)
Correlation between hand osteoarticular involvement in 7.0 T RMI and general and SSc-related factors, including hand vascular involvement, in SSc patients
Proportion of hand osteoarticular abnormalities and : age (yrs) ; SSc duration (yrs) ; bone mass index ; modified Rodnan skin score (0-51) ; interlabial length (cm) ; arterial pattern in the hand in 7.0 T RMI ; proportions of female, active tabagism, SSc subtypes, SSc-related autoantibodies, antiphospholipid autoantibodies, immunosuppressant use, vasoactive drugs and SSc-related visceral involvement (Raynaud's phenomenon, digital tip ulcerations and/or gangrene and/or amputation, arterial pulmonary hypertension, interstitial lung disease, upper and/or lower digital tract involvement, renal crisis, arthritis, inflammatory myopathy, subcutaneous calcifications, telangiectasia) ; EUSTAR-Activity Index ; NT-proBNP level (ng/mL) ; troponin level (ng/mL) ; C reactive protein level (mg/L) ; proportion of capillaroscopic pattern (cutulo's classification) ; Raynaud's Condition Score ; patient's visual scale for Raynaud's phenomenon severity (1 to 10) ; SSc-HAQ ; "main de Cochin" score
Time frame: 7 days maximum (delay between realization of the RMI and its final interpretation)
Correlation between hand arterial involvement in 7.0 T RMI and general and SSc-related factors, including hand osteoarticular involvement, in SSc patients
Proportion of hand hand arterial abnormalities and : age (yrs) ; SSc duration (yrs) ; bone mass index ; modified Rodnan skin score (0-51) ; interlabial length (cm) ; hand osteoarticular abnormalities in 7.0 T RMI ; proportions of female, active tabagism, SSc subtypes, SSc-related autoantibodies, antiphospholipid autoantibodies, immunosuppressant use, vasoactive drugs and SSc-related visceral involvement (Raynaud's phenomenon, digital tip ulcerations and/or gangrene and/or amputation, arterial pulmonary hypertension, interstitial lung disease, upper and/or lower digital tract involvement, renal crisis, arthritis, inflammatory myopathy, subcutaneous calcifications, telangiectasia) ; EUSTAR-Activity Index ; NT-proBNP level (ng/mL) ; troponin level (ng/mL) ; C reactive protein level (mg/L) ; proportion of capillaroscopic pattern (cutulo's classification) ; Raynaud's Condition Score ; patient's visual scale for Raynaud's phenomenon severity (1 to 10) ; SSc-HAQ ; "main de Cochin" score
Time frame: 7 days maximum (delay between realization of the RMI and its final interpretation)
Sodium articular concentration in the hand in 7.0 T RMI in SSc patients and control subjects
Mean values of sodium articular concentration in the hands of SSc patients of control subjects
Time frame: 7 days maximum (delay between realization of the RMI and its final interpretation)
Plan to share: Undecided
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