Clinical trial NCT04223817: 7.0 Tesla Resonance Magnetic Imaging of the Hand in Systemic Sclerosis
Official title: Contribution of 7.0 Tesla RMI in Screening of Osteoarticular Involvement and Vasculopathy of the Hands in Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Sclerosis
7.0 Tesla Magnetic Resonance Imaging
Hand Vascular Involvement
Hand Osteoarticular Involvement
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: SSc patients compared to control subjects without SSc matched on sex and age
Primary purpose: SCREENING

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of hand osteoarticular involvement in SSc and control subjects in 7.0 T RMI
timeFrame: 7 days maximum (delay between realization of the RMI and its final interpretation)
Secondary outcomes:
measure: Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI
timeFrame: 7 days maximum (delay between realization of the RMI and its final interpretation)
measure: Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI
timeFrame: 7 days maximum (delay between realization of the RMI and its final interpretation)
measure: Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI
timeFrame: 7 days maximum (delay between realization of the RMI and its final interpretation)
measure: Arterial pattern in the hand of SSc patients and control subjects in 7.0 T RMI
timeFrame: 7 days maximum (delay between realization of the RMI and its final interpretation)
measure: Correlation between hand osteoarticular involvement in 7.0 T RMI and general and SSc-related factors, including hand vascular involvement, in SSc patients
timeFrame: 7 days maximum (delay between realization of the RMI and its final interpretation)
measure: Correlation between hand arterial involvement in 7.0 T RMI and general and SSc-related factors, including hand osteoarticular involvement, in SSc patients
timeFrame: 7 days maximum (delay between realization of the RMI and its final interpretation)
measure: Sodium articular concentration in the hand in 7.0 T RMI in SSc patients and control subjects
timeFrame: 7 days maximum (delay between realization of the RMI and its final interpretation)
Other outcomes:
Locations:
Study officials:
References: