Validation of Low Field MRI in Patients With Stroke Symptoms Less Than 12 Hours
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of low-field MRI for acute stroke detection
研究概览
简要总结
This study evaluates the accuracy and feasibility of a portable low-field MRI (Hyperfine) device in patients presenting to the emergency department with suspected acute stroke. All enrolled patients undergo standard clinical imaging (CT, CT angiography, CT perfusion) and additionally receive a low-field MRI scan. Low-field MRI findings are compared to routine CT imaging and final clinical diagnosis. The study aims to determine whether low-field MRI can reliably detect acute ischemic stroke (including lacunar and large vessel occlusion), hemorrhagic stroke, and stroke mimics in the acute setting. Secondary outcomes include feasibility measures such as scan time, completion rate, patient satisfaction, and adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Presentation with suspected acute stroke (stroke code activation by ambulance paramedics)
- •Symptom onset < 12 hours prior to presentation
- •Admission to the emergency department of the Leiden University Medical Center (LUMC) during office hours
- •Undergoing standard-of-care head CT imaging at the emergency department
- •Ability to provide informed consent (written or verbal in the acute setting, with deferred written consent if applicable)
排除标准
- •Imminent death
- •Severe claustrophobia preventing MRI
- •Presence of MRI-incompatible implanted devices (e.g., pacemaker, cochlear implant, insulin pump)
- •Known intra-ocular metallic foreign body or intracranial metallic clip/device identified on admission CT
- •Pregnancy
- •Acute life-threatening or disabling condition requiring immediate intervention that precludes study procedures
- •Any study-related delay that could interfere with time-critical stroke treatments (intravenous thrombolysis or endovascular thrombectomy)
研究组 & 干预措施
Hemorrhagic stroke
Patients with hemorrhagic stroke (intracerebral hemorrhage) demonstrated on non-contrast CT at the emergency department. All patients undergo low-field MRI scanning in addition to routine clinical imaging.
干预措施: Low-field MRI (Device)
Ischemic stroke - lacunar infarct
Patients with clinical and radiological suspicion of lacunar ischemic stroke (subcortical infarct). These patients often receive additional conventional MRI during routine work-up for radiological confirmation. All patients undergo low-field MRI scanning in addition to routine clinical imaging.
干预措施: Low-field MRI (Device)
Stroke mimic
Patients with non-stroke diagnosis based on clinical judgment and neuro-imaging at the emergency department (e.g., epilepsy, migraine, functional neurological disorder). All patients undergo low-field MRI scanning in addition to routine clinical imaging.
干预措施: Low-field MRI (Device)
Ischemic stroke - proximal vessel occlusion
Patients with ischemic stroke due to proximal vessel occlusion in the anterior circulation (large vessel occlusion, LVO) diagnosed by CT angiography at the emergency department. All patients in this group undergo low-field MRI scanning in addition to routine clinical imaging.
干预措施: Low-field MRI (Device)
结局指标
主要结局
Diagnostic accuracy of low-field MRI for acute stroke detection
时间窗: At time of low-field MRI scan (within 12 hours of symptom onset)
Sensitivity, specificity, positive predictive value, and negative predictive value of low-field MRI findings for detecting acute stroke (ischemic or hemorrhagic) and stroke mimics, using final clinical diagnosis at discharge as the reference standard. Low-field MRI images are assessed by a neuroradiologist blinded to CT findings and final diagnosis.
次要结局
- Adverse events during low-field MRI scanning(During low-field MRI scan and up to 30 minutes thereafter)
- Patient satisfaction with low-field MRI procedure(Within 24 hours after low-field MRI scan.)
研究者
Nyika D. Kruyt
Neurologist
Leiden University Medical Center