The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 285
- 试验地点
- 6
- 主要终点
- Diagnostic performance of ONSD to identify new-onset GCA
研究概览
简要总结
The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis (SONIC-GCA) study will evaluate the performance of the optic nerve sheath diameter (ONSD), measured via ultrasound, to diagnose and monitor GCA. SONIC-GCA builds upon our previous pilot studies and will answer the following questions:
- What is the performance of ONSD to identify patients with new-onset, active GCA?
- Is ONSD useful for monitoring GCA relapses during follow-up?
- What is the intra- and interobserver reliability of ONSD measurements?
- Does ONSD differ between patients with and without GCA-related retinal findings?
详细描述
SONIC-GCA is a prospective cohort and validation study conducted in centers of the Canadian Vasculitis Research Network (CanVasc).
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
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Diagnostic performance of ONSD to identify new-onset GCA
时间窗: Baseline
The primary outcome of SONIC-GCA is to determine the optimal ONSD cutoff for identifying GCA at the baseline visit and to assess its diagnostic performance, including sensitivity, specificity, positive and negative predictive values, and accuracy.
ONSD in patients with and without GCA
时间窗: Baseline
At baseline, ONSD measurements (in mm) of the left and right eyes of each participant will be recorded and used to calculate the mean ONSD for patients with and without GCA.
次要结局
- ONSD changes over time(Up to 2 years)
- The associations between ONSD changes and GCA relapses(Up to 2 years)
- Evaluation of the performance of ONSD to detect a GCA relapse(Up to 2 years)
研究者
Jean-Paul Makhzoum
Director - Vasculitis Research Program, Principal Investigator
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal