The Applanation Tonometry in Giant Cell Arteritis Pilot
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- PWV in patients with and without GCA
研究概览
简要总结
The Applanation Tonometry in Giant Cell Arteritis (ATOM-GCA) study will answer the following questions:
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How does PWV, measured by applanation tonometry of temporal arteries, differ between patients with and without a final diagnosis of GCA (based on pre-defined criteria 6 months after inclusion)?
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What is the diagnostic accuracy and positivity cutoff of the PWV, measured by applanation tonometry, in detecting:
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A clinical diagnosis of GCA (based on pre-defined criteria 6 months after inclusion)?
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Inflammation of temporal arteries on high-resolution ultrasound?
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What is the acceptability and adherence of repeat applanation tonometry during the follow-up period in patients with GCA?
详细描述
ATOM-GCA is a single-center, cross-sectional vanguard study.
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
PWV in patients with and without GCA
时间窗: Baseline
The primary outcome of ATOM-GCA is to compare the mean PWV in patients with GCA to the mean PWV in individuals without GCA. Final confirmation of GCA will be determined 6 months after study inclusion. This analysis will establish whether the PWV differs in GCA. Additionally, we will explore the optimal PWV cutoff and evaluate its diagnostic performance to confirm a final diagnosis of GCA at 6 months.
次要结局
- Diagnostic performance of the PWV(Baseline)
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