Contribution of 7.0 Tesla RMI in Screening of Osteoarticular Involvement and Vasculopathy of the Hands in Systemic Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Frequency of hand osteoarticular involvement in SSc and control subjects in 7.0 T RMI
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Frequency of hand osteoarticular involvement in SSc and control subjects in 7.0 T RMI
时间窗: 7 days maximum (delay between realization of the RMI and its final interpretation)
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
次要结局
- Correlation between hand osteoarticular involvement in 7.0 T RMI and general and SSc-related factors, including hand vascular involvement, in SSc patients(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(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(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(7 days maximum (delay between realization of the RMI and its final interpretation))