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临床试验/EUCTR2020-000352-36-DK
EUCTR2020-000352-36-DK进行中(未招募)1 期

MRI of neurometabolic impairment in ALS and TIA using hyperpolarized pyruvate

Christoffer Laustsen0 个研究点目标入组 46 人开始时间: 2020年2月13日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
46

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

  • All participants:
  • -Aged 18 – 85 years. The age and gender of the healthy controls of the main study will be matched to the patients in ALS and TIA groups
  • -Pre-menopausal women must be confirmed non-pregnant by an onsite test
  • -Fulfilling the 2015 revised El Escorial criteria
  • -Upper motor neuron symptoms
  • -TIA within the last 10 days. TIA is defined as symptoms shorter than 24 hours (time definition) with a likely vascular genesis (mimics such as urinary tract infection, hypoglycemia and migraine are excluded)
  • -Symptoms must include unilateral weakness of face and/or limb
  • -Symptom duration > 10 minutes
  • 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 25
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 21

排除标准

  • Contraindications for MRI with contrast:
  • -Chronic kidney disease
  • -Significant cardiac disease such as severe left ventricular outflow obstruction
  • -Significant obstructive lung disease or severe asthma
  • -Pacemaker, neurostimulator or cholera implant
  • -Metal foreign bodies such as fragments and irremovable piercings
  • -Unsafe medical implants (safety of heart valves, hips and the like must be confirmed)
  • -Intracranial clips or coils
  • -Claustrophobia
  • -Largest circumference including arms > 160 cm
  • Competing neurological, psychiatric, liver or systemic disease including diabetes (except prior TIA, unspecific brain MRI findings, hypertension, atherosclerosis and hyperlipidemia/cholesterolemia which are allowed)

研究者

发起方
Christoffer Laustsen

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