7.0 Tesla Resonance Magnetic Imaging of the Hand in Systemic Sclerosis

Systemic Sclerosis Clinical Trial

— PREM'S  

Official title:

Contribution of 7.0 Tesla RMI in Screening of Osteoarticular Involvement and Vasculopathy of the Hands in Systemic Sclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04223817
• Other study ID #: 2019-A02760-57
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2021
• Source: Poitiers University Hospital
• Contact: Mickaël MARTIN, MD, PhD
• Phone: 0549444004
• Email: mickael.martin[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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:

• Age = 18 years-old

• Written informatory consent

Exclusion Criteria:

• Patients with SSc:

• SSc associated with other define autoimmune disease (overlap syndrome)

• For both:

• Absolute contraindication to 7.0 T RMI: pregnancy; ocular metallic foreign body ; cardiac pacemaker ; neurostimulator no compatible 7.0 T RMI ; cochlear implants; all electronic medical device implantedfor less than 6 weeks ; metallic heart valve ; old cranial vascular clips

• Individuals with current health condition not allowing realization of the 7.0 T RMI in sufficient comfort conditions according to investigator appreciation (i.e. acute cardiac and/or respiratory failure, impossibility to maintain procubitus, bedridden individuals, claustrophobia)

• Individuals under tutorship or guardianship

• Individuals with reinforced protection: minors, judiciary or administrative decision

• No affiliation to social insurance

• Pregnancy or breastfeeding

Related Conditions & MeSH terms

• 0 Tesla Magnetic Resonance Imaging
• Hand Osteoarticular Involvement
• Hand Vascular Involvement
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Device:
• 7.0 T RMI
Single 7.0 Tesla MRI of both hands in the same time

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 days maximum (delay between realization of the RMI and its final interpretation)
Secondary	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	7 days maximum (delay between realization of the RMI and its final interpretation)
Secondary	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	7 days maximum (delay between realization of the RMI and its final interpretation)
Secondary	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	7 days maximum (delay between realization of the RMI and its final interpretation)
Secondary	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	7 days maximum (delay between realization of the RMI and its final interpretation)
Secondary	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	7 days maximum (delay between realization of the RMI and its final interpretation)
Secondary	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	7 days maximum (delay between realization of the RMI and its final interpretation)
Secondary	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	7 days maximum (delay between realization of the RMI and its final interpretation)