2024-516954-24-00招募中2 期
MRI of Neurometabolic Impairment in ALS and TIA Using Hyperpolarized Pyruvate
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Cerebral metabolism as assesed with 13C label exchange from hyperpolarized pyruvate to bicarbonate, lactate and alanine
研究概览
简要总结
This project seeks to detect and characterize metabolic impairment in patients with Amyotrophic Lateral Sclerosis and patients with Transient Ischemic attack with a new MRI technique termed Hyperpolarized Pyruvate MRI
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •All participants: 1) Age 18-85 years. 2) Pre-menopausal women must be confirmed non-pregnant by an onsite test. ALS group: 1) Fulfilling the 2021 Gold Coast criteria. 2) Upper motor neuron symptoms. TIA-group: 1) TIA within the last 10 days. 2) Symptoms must include unilateral weakness of limb or face. 3) Duration af symptoms minimum 10 minutes
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). Allergy to pyruvate.
结局指标
主要结局
Cerebral metabolism as assesed with 13C label exchange from hyperpolarized pyruvate to bicarbonate, lactate and alanine
Cerebral metabolism as assesed with 13C label exchange from hyperpolarized pyruvate to bicarbonate, lactate and alanine
次要结局
- Disease characterization from clinical exsamination, interviews and patient records.
研究者
MR Research Centre Aarhus University
Scientific
Aarhus Universitet
研究点 (1)
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