NCT02473029终止不适用
Interest of Medical Imaging in the Diagnostic Strategy Vis a Vis a Suspected Horton Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- MRI angiography mural inflammation
研究概览
简要总结
The study aims at measuring the sensitivity and specificity of a series of imaging signs (recorded by magnetic resonance angiography, vascular tomodensitometry, vascular ultrasonography, retina angiography and retina optic coherence tomography) for the diagnosis of Horton disease, the gold standard being the result of temporal artery biopsy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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 admitted to the Fondation Ophtalmologique Adolphe de Rothschild and suspected to suffer from Horton disease, based on the presence of 3 or more major criteria, or 2 major criteria and at least one minor criteria.
- •Major criteria : Age > 50 ans ; headache ; intermittent jaw or tongue pain ; visual impairment ; ESR > 50 mm at 1h and/or CRP > 8mg/l.
- •Minor criteria: temporal artery or scalp tenderness ; facial pain or tenderness ; fever >38°C, weight loss >10%, anorexia, fatigue.
排除标准
- •Autoimmune disease
- •Active infectious condition
- •Malignant disease
- •Condition counterindicating one or several of the protocol's imaging procedures : allergy to iodine and/or renal insufficiency and/or claustrophobia and/or metallic foreign body...
结局指标
主要结局
MRI angiography mural inflammation
时间窗: Baseline
Presence of signs of artery mural inflammation in T1 sequence of MRI angiography
次要结局
未报告次要终点
研究者
研究点 (1)
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