跳至主要内容
临床试验/NCT06211725
NCT06211725招募中不适用

The VANGAS-Trial. The Value of Neurofilament Light Chain and Glial Fibrillary Acid Protein in the Blood of Patients With Asymptomatic Carotid Artery Stenosis

Heinrich-Heine University, Duesseldorf2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
Correlation of NF-L/GFAP with degree of stenosis (NASCET-Criteria)

研究概览

简要总结

Stroke is the second leading cause of death and the third leading cause of disability worldwide. The cause is usually either a blockage or a severe narrowing of a cerebral artery. An important part of stroke prevention is the diagnosis and clarification of stenosis in the arteries supplying the brain, both inside and outside the skull, in order to diagnose a high-grade stenosis at an early stage and offer the patient revascularization. In particular, asymptomatic carotid artery stenosis confronts the diagnosing physician with the question of whether revascularisation is necessary.

Risk factors for stroke in asymptomatic carotid artery stenosis include contralateral TIA or cerebral infarction, male gender, rapid progression of the degree of stenosis, plaque morphology, clinically silent cerebral infarctions, Doppler sonographic evidence of microemboli or reduced vasomotor reserve. An established biomarker does not exist at this time. A candidate for such a biomarker in the blood is the protein "neurofilament light chain" (NFL), which is already established in the diagnosis of dementia. As a component of the cytoskeleton of neurons, it is released into the patient's blood when the cells are damaged and can be measured there. Another candidate is glial fibrillary acid protein (GFAP), a part of the cytoskeleton of glial cells that is also released into the blood when glial cells are damaged. A systematic investigation of the value of neurofilament light chain and the glial fibrillary acidic protein in the blood of patients with asymptomatic carotid stenosis is still lacking. VANGAS determines the value of NFL and GFAP from the blood of patients with asymptomatic carotid stenosis to determine associations with the degree of stenosis, the natural course of the stenosis (increase or decrease) and possible symptoms of the stenosis as well as the functional outcome after symptomatic stenosis.

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
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 60- 80 years
  • 0-100 % stenosis of the internal carotid artery

排除标准

  • Neurodegenerative diseases such as any form of dementia or Parkinson's disease
  • Polyneuropathy
  • Multiple sclerosis
  • Stroke (ischaemic or haemorrhagic) within the last 12 months
  • Transient ischaemic attack within the last 12 months
  • Neurotrauma within the last 12 months
  • Atrial fibrillation

结局指标

主要结局

Correlation of NF-L/GFAP with degree of stenosis (NASCET-Criteria)

时间窗: 24 months

The amount of NF-L and GFAP in the blood of patients with stenosis of a brain-supplying artery correlates with the degree of the stenosis.

次要结局

  • Correlation of NF-L/GFAP with functional outcome (modified rankin scale)(24 months)
  • Correlation of NF-L/GFAP with progression of stenosis (NASCET-Criteria)(24 months)
  • Correlation of NF-L/GFAP with future cerebral ischemia (Stroke / TIA)(24 months)

研究者

发起方
Heinrich-Heine University, Duesseldorf
申办方类型
Other
责任方
Sponsor

研究点 (2)

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