NCT02308579已完成不适用
Prevalence of Chronic Cerebrospinal Venous Insufficiency in Patients With Multiple Sclerosis and Other Neurological Diseases. An Ultrasound, Blinded, Case-Controlled, Centralized Reading Assessment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 499
- 主要终点
- Number of MS (or CIS) and HC (or OND) who have 5 VH CCSVI CDUS criteria on doppler ultrasound
研究概览
简要总结
This a retrospective, blinded trial in which collaborators in Italy will review the doppler findings from the Combined Transcranial and Extracranial Venous Doppler (CTEVD) trial in an attempt to measure reproducibility.
详细描述
This study will retrospectively investigate doppler images from the second phase of the CTEVD trial.
- To determine the prevalence of CCSVI in patients with MS, compared with the prevalence observed in a control population consisting of Other Neurological Diseases (OND) patients and Healthy Controls (HC) by using blinded, controlled centralized ultrasound reading assessment of 5 Venous Haemodynamic (VH) CCSVI CCSVI Doppler UltraSound (CDUS) criteria.
- To investigate whether prevalence of CCSVI is different between centralized and local CDUS reading of 5 VH CCSVI CDUS criteria.
- To investigate the prevalence of CCSVI in patients with MS, compared with the prevalence observed in a control population consisting of OND patients and HC, when bidirectional flow in the intracranial veins and sinuses CDUS criterion is not considered as part of VH CCSVI CDUS criteria.
- To determine whether prevalence of CCSVI in patients with MS, compared with the prevalence observed in a control population consisting of OND patients and HC differs when using CDUS velocity and flow parameters in the Internal Jugular Veins (IJVs) and Vertebral Veins (VVs).
- To determine the reproducibility of VH criteria by using of centralized and local blinded, controlled CDUS reading assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 5 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in the CTEVD Phase 2 study
- •Available CDUS exam
- •Diagnosed with CIS, MS, OND, or being a HC
- •Fulfilling inclusion criteria from the CTEVD study
排除标准
- •Not having an available CDUS exam
- •Diagnosed with Radiologically Isolated Syndrome (RIS) or Neuromyelitis Optic (NMO)
- •Fulfilling exclusion criteria from the CTEVD study
结局指标
主要结局
Number of MS (or CIS) and HC (or OND) who have 5 VH CCSVI CDUS criteria on doppler ultrasound
时间窗: Baseline
The prevalence (number) of MS/CIS vs. HC/OND who fulfill the 5 venous haemodynamic (VH) criteria on doppler ultrasound.
次要结局
未报告次要终点
研究者
Robert Zivadinov, MD, PhD
Professor of Neurology
University at Buffalo
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