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
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