Evaluation of a Diagnostic Strategy for Giant Cell Arteritis Based on Color Doppler Ultrasound of Temporal Arteries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 6
- 主要终点
- Number of CDU False-positive Patients
研究概览
简要总结
Giant cell arteritis (GCA or temporal arteritis or cranial arteritis) or Horton disease is a vasculitis that occurs in older adults, affecting vessels of medium and large caliber. The diagnosis of GCA is a challenge for general practitioners and specialists. Since 1970, it is based on a combination of clinical, biological and histological signs. Temporal artery biopsy (TAB) was the reference method until recently. However, TAB has many drawbacks. Therefore, researches of the past 20 years have been intended to develop alternative diagnostic methods. This was notably the case of the color Doppler ultrasound (CDU) since the description by Wolfgang Schmidt of the halo sign. Although European and British recommendations put CDU as second line method, many authors suggest the possibility to do without TAB in many cases. In addition, many practitioners believe that it is not "ethical" to use an invasive unprofitable procedure like TAB, and have already been using CDU in their routine practice. However, no diagnostic algorithm validating this approach in a prospective series has been published to date. Therefore, the present study aim at validating a diagnostic algorithm of giant cell arteritis using color Doppler imaging of temporal arteries and cervicocephalic axes as first screening method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 50 years
- •C reactive protein (CRP) above normal
- •Suspected of GCA according to clinician expertise and / or aortitis arteritis or of one or more arteries from the aorta imaging (CT angiography, magnetic resonance angiography or positron emission tomography TDM18FDG)
- •Benefiting from Social Security or receiving it via a third party
- •have given their participation agreement by understanding and accepting the constraints of the study
排除标准
- •Received corticosteroid dose ≥ 20 mg of prednisone equivalent for more than 7 days in the month before inclusion
- •Underwent temporal artery biopsy before color Doppler ultrasound
- •History of GCA
- •Terminal palliative phase or suffering from a disease or comorbidities such as life is involved in less than a year
- •Patient with severe cognitive impairment
- •Patient that can not be followed by the investigator for the duration of the study
- •Refusal to participate in the study
- •With enhanced protection (namely those deprived of liberty by a court or administrative order, patient staying in a health or social institution, under legal protection, and patients in emergencies)
- •Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception
- •Participating in another clinical trial.
研究组 & 干预措施
GCA suspicion
A first screening is performed using color Doppler ultrasound. In case of negative results, patients undergo TAB.
干预措施: color Doppler ultrasound and TAB in case of CDU negative (Other)
结局指标
主要结局
Number of CDU False-positive Patients
时间窗: after 2 years of follow-up
patients with an alternative diagnosis within 2 years of follow-up among patients considered with giant cell arteritis (GCA) on a clinico-biological suspicion + Doppler "positive."
次要结局
- Number of Correctly Interpreted TAB(1 month (after second blind reading of histological specimen and doppler imaging))
- Rate of "Temporal Artery Biopsy Positive" Among "Negative or Doubtful CDU "(within 1 month (during diagnostic algorithm))
- Number of Correctly Interpreted CDU(1 month (after second blind reading of histological specimen and doppler imaging))
- Number of Patients With a Persistent Halo at Second CDU Examination(after 2 years of follow-up)