Association of Ultrasonographic Temporal Artery Lesions and Relapse in Patients With Giant Cell Arteritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Relapse according to EULAR 2018 criteria
研究概览
简要总结
Ultrasound evaluation of the temporal and axillary arteries is currently well recognized in the field of giant cell arteritis (GCA), a disease primarily affecting medium- and large-caliber vessels. Structural ultrasound abnormalities are now well described in this pathology, but their association with relapse and clinical concordance is unknown. There is currently a follow-up score (the OGUS score) for medium- and large-caliber arteries that could also predict the clinical course of the disease.
详细描述
Prospective bicentric longitudinal study evaluating the association between ultrasound lesions and clinico-biological relapse in patients with giant cell arteritis.
This is a non-interventional study with patients routinely followed for their pathology and classically benefiting from temporal artery ultrasound as part of their disease. Recruitment will be facilitated by the fact that these will be "general population" patients with suspected giant cell arteritis.
The center will enroll 100 patients. The study will take place over 3 visits, including a clinical, biological and ultrasound examination. Ultrasound will not be blinded to the clinic, so we will only need one examiner in the center.
This is a study in routine care, with no additional costs and no expected constraints. The ultrasound examination will be performed as part of their routine follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Major patient
- •Patients meeting ACR 2022 criteria for giant cell arteritis.
- •No opposition expressed
排除标准
- •Patients unable to understand the protocol, under guardianship or curatorship.
- •Patients not affiliated to the French Social Security system.
结局指标
主要结局
Relapse according to EULAR 2018 criteria
时间窗: At 12 months
Relapse is defined with European League Against Rheumatism recommendations according to major or minor relapse criteria.
次要结局
- Relapse according to EULAR 2018 criteria(At 6 month; at 12 month)
- Clinical parameter : Age(At inclusion)
- Other prognostic marker : C-Reactive Protein(At inclusion, At 6 month, At 12 month)
- Clinical parameter : scalp paresthesia(At inclusion)
- Clinical parameter : abnormal palpation of the temporal arteries(At inclusion)
- Clinical parameter : morning stiffness of shoulders and/or neck(At inclusion)
- Biological parameter : temporal artery biopsy(At inclusion)
- Biological parameter : halo sign on ultrasound(At inclusion)
- Biological parameter : Sedimentation rate(At inclusion)
- Biological parameter : C-Reactive Protein(At inclusion)
- Other prognostic marker : hemoglobin(At inclusion, At 6 month, At 12 month)
- Other prognostic marker : leukocytes(At inclusion, At 6 month, At 12 month)
- Other prognostic markers : platelets(At inclusion, At 6 month, At 12 month)
- Other prognostic marker : Sedimentation rate(At inclusion, At 6 month, At 12 month)
- OMERACT Giant Cells arteritis Ultrasonography Score (OGUS)(At 6 month, at 12 month)
- C-Reactive Protein(At 6 month, at 12 month)
- Erythrocyte Sedimentation Rate (ESR)(At 6 month, at 12 month)
- Clinical parameter : loss of vision(At inclusion)
- Clinical parameter : claudication of the jaw or tongue(At inclusion)
- Clinical parameter : temporal headaches(At inclusion)
- Biological parameter : bilateral axillary involvement(At inclusion)
- Biological parameter : aortitis(At inclusion)