跳至主要内容
临床试验/NCT03555643
NCT03555643已完成不适用

Evaluation of the Hyperintense Acute Reperfusion Marker for the Detection of a Cerebral Ischemia in the Anterior and Posterior Circulation in Patients With Transient Ischemic/Neurological Attack

Universitätsmedizin Mannheim1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2017年11月1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
96
试验地点
1
主要终点
hyperintense acute reperfusion marker (HARM)

研究概览

简要总结

The research project investigates the incidence of the hyperintense acute reperfusion marker (HARM) in patients with transient ischemic attack (TIA) or transient neurological attack (TNA). Initially, HARM was described after acute ischemic stroke and is caused by a blood-brain barrier disorder after recanalization of an acute vessel occlusion and consecutive reperfusion. These result in a contrast agent extravasation into the subarachnoid space, which can be easily detected on fluid attenuated inversion recovery (FLAIR) images.

TIA is defined as a transient focal neurological deficit with a probably cerebrovascular cause. In contrast, TNA is defined as a transient non-focal neurological deficit with multiple causes, including cerebrovascular. The clinical diagnosis of TIA is often flawed and the delineation of TIA and TNA can be difficult. MRI is the most important diagnostic method for the detection or exclusion of cerebral ischemia in patients with TIA/TNA in daily clinical practice. However, on diffusion-weighted imaging (DWI) approximately two-thirds of TIA cases and only one-fifth of TNA cases demonstrate acute cerebral ischemia. Supplementary perfusion-weighted imaging (PWI) scans can only slightly increase this percentage. The well-known HARM could prove to be complementary to DWI and PWI and close or at least reduce the existing gap. In the case of TNA in particular, this could be of clinical relevance in order to avoid mistreatment or even dismissal without further clarification after supposedly inconspicuous imaging.

Therefore, the aim of this study is to record the incidence of HARM in a statistically significant number of cases of patients with TIA and TNA and to investigate relationships with symptom duration and anatomical localization. In addition, the dynamics of contrast enhancement in the subarachnoid space in TIA and TNA cases with HARM will be analyzed in detail.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • transient focal neurological symptoms (aphasia, facial paresis, hemiparesis, hemihypaesthesia, double vision, hemianopia, hemiataxia, etc.)
  • transient non-focal neurological symptoms (confusion, dizziness, memory deficits, gait insecurity, bilateral weakness, etc.)
  • MRI examination possible within 24 hours of symptoms
  • able to give informed consent

排除标准

  • persistent symptoms
  • symptoms lasting more than > 24 h
  • clinical suspicion of other cause of symptoms (seizures, intoxication, hypoglycemia, psychogenic)
  • contraindications for MRI (pacemaker, metallic splinter, cochlear implants, etc.)
  • unable to give consent

结局指标

主要结局

hyperintense acute reperfusion marker (HARM)

时间窗: within 24 hours after onset of symptoms

Detection of the hyperintense acute reperfusion marker (HARM) on postcontrast FLAIR images.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alex Förster

MD

Universitätsmedizin Mannheim

研究点 (1)

Loading locations...

相似试验