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临床试验/EUCTR2016-002911-16-NL
EUCTR2016-002911-16-NL进行中(未招募)1 期

PET/MRI and plaque vulnerabilityA feasibility study of 18F-Flutemetamol in atherosclerosis - PET/MRI and plaque vulnerability: Flutemetamol

Maastricht University Medical Center0 个研究点目标入组 25 人开始时间: 2016年11月3日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
25

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Age 18 years and older (no maximum age)
  • Informed consent by signed informed consent form regarding this study
  • Either: Patients, who are scheduled for carotid endarterectomy (CEA)
  • Or: Patients who are not scheduled to undergo a CEA, but have experienced a TIA/CVA/amaurosis fugax within the last 14 days and at least a 30% stenosis of the symptomatic carotid artery as based on flow velocities with duplex ultrasonography.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 5
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • Severe cognitive impairment, neurological deficit or comorbidity causing the study to be too high a burden for the patient or disrupting patient’s co-operation with scan procedures.
  • Evident other causality for stroke (cardiac embolus, small vessel disease, carotid dissection or thrombogenic diathesis).
  • Pregnant women and nursing mothers.
  • Contra-indications for MRI.
  • ?Relative contra-indications for MRI-contrast agent: GFR <30ml/min/1,73m2/Previous allergic reaction to MRI contrast agent.
  • Contra-indication Flutemetamol: Hypersensitivity to the active substance or to any of the excipients

研究者

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