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
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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