A Longitudinal Study of Orbital and Cranial Vessel Wall MRI in Giant Cell Arteritis by the Vascular MRI Evaluation in Giant Cell Arteritis (VEGA) Collaborative
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Vessel Wall Enhancement Score
研究概览
简要总结
The research study is being conducted to determine the utility of magnetic resonance imaging (MRI) in identifying inflammation of arteries supplying blood to the head, brain, and eyes. The target population includes patient with suspected giant cell arteritis (GCA; temporal arteritis).
详细描述
After signing the consent form, participants will complete an MRI scan within 2 weeks of enrollment and fill out questionnaires related to their disease. Follow up visits and MRI scans may occur at 6-months after the initial MRI scan or at the time of relapse.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 50 years or older
- •First presentation of suspected GCA
- •New or worsening cranial manifestations within 4 weeks of enrollment concerning for active GCA
- •Elevated CRP greater than 1.0 mg/dl
- •Plan to undergo temporal artery biopsy or ultrasound for diagnosis
排除标准
- •Contra-indication to receiving MRI including:
- •Implanted medical devices, pacemaker, and metallic foreign fragments inside body/orbits Known gadolinium allergy Women who are pregnant or nursing
- •Absence of cranial symptoms related to GCA (e.g., only large vessel GCA)
结局指标
主要结局
Vessel Wall Enhancement Score
时间窗: Up to 12 months
Enhancement of cranial vessel wall, orbital structures, or other cranial structures. Scores range from 0 to 3; 0 being no inflammation and 3 being more enhancement or inflammation.
次要结局
未报告次要终点
研究者
Rennie Rhee, M.D., MSCE
Assistant Professor of Medicine
University of Pennsylvania