跳至主要内容
临床试验/NCT03618251
NCT03618251已完成不适用

Evaluation of Infarct Volumetric Software in Strokes of Less Than 24 Hours

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 406 人开始时间: 2018年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
406
试验地点
1
主要终点
Automated volume assessment of acute stroke

研究概览

简要总结

Stroke is a common disease. It is increasingly managed in non-specialized centers.

The volume of the lesion, evaluated on the diffusion weighted imaging, is a prognostic factor of clinical progression and is useful for the treatment decision.

There is therefore a real interest in having a reliable software able to detect the stroke and evaluate the volume of the cerebral infarction. The aim is to provide rapid information to the interventional neuroradiologist and optimize the care of the patient.

The Alberta Stroke Program Early Computed Tomography Score currently used to predict response to treatment divides the territory of the middle cerebral artery. It has a few limitations, it is unreproducible and concerns only the territory of the middle cerebral artery.

Manual volumetry is a long and also not very reproducible technique. The aim of our study is to evaluate the reproducibility and diagnostic performances of the automated segmentation software based on the diffusion weighted imaging sequence, and to compare it to manual and semi-automatic measurements.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients admitted for a recent neurological deficit (less than 24 hours), suspected for a stroke.
  • Non inclusion criteria :
  • Pregnant or breastfeeding women
  • Patients with absolute contraindications to MRI

排除标准

  • 未提供

结局指标

主要结局

Automated volume assessment of acute stroke

时间窗: 1 hour

Our objective is to compare several volumetric techniques (manual, semi-manual, automatic) based on the B 2000 of diffusion weighted imaging and the coefficient of apparent diffusion. We will also evaluate the correlation between the volumes obtained by the different techniques and the final volume of FLAIR infarction and diffusion in a subgroup of patients for whom a follow-up MRI is feasible.

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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