NCT06278129招募中不适用
Evaluation of the Diagnostic and Prognostic Efficacy of Magnetic Resonance Imaging in Patients With Acute Sensorineural Hearing Loss and Ménière's Disease
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年6月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Evaluation of inner ear structures in MRI images
研究概览
简要总结
Evaluation of the diagnostic and prognostic efficacy of nuclear magnetic resonance imaging in patients with acute sensorineural hearing loss or in patients suffering from probable or definite MD. The neuroradiological and audiological evaluation are held on in the same day in order to better clarify the radiological and clinical correlates.
详细描述
Aims of the study:
- Evaluate the diagnostic accuracy of MRI with the collection of more specific sequences for the inner ear (3D-FLAIR) in identifying intralabyrinthine anomalies in patients with Ménière's disease or acute/subacute sudden hearing loss and not only the retrochlear pathology/neurological causes .
- Characterize the vascular and inflammatory MRI patterns
- Define the prognostic role of MRI with pre- and post-contrast 3D-FLAIR sequence, eliminating confounding factors such as MRI execution time, the methodology used, the effect of previous therapy and the criteria for defining improvement.
- Correlate 4-hour 3D-FLAIR MRI imaging data with clinical and hematological data
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
- •onset of symptoms less than 10 days
- •no previous episodes of sudden ipsilateral hearing loss
- •no systemic or oral corticosteroid intake in the previous month
- •Informed consent
排除标准
- •Current or previous otopathy and/or labyrinth diseases of known cause
- •Known nervous system disorders
- •Patients with renal insufficiency (creatinine level > 1.5 mg/dL)
- •Patients with pacemakers, other metal implants, claustrophobics and known psychiatric disorders
- •Pregnant patients Materials and methods Diagnostic evaluation at enrollment (T0)
- •Audiological or ENT examination
- •Liminal tonal audiometric exam, vocal, impedance measurement, otoacoustic emissions, video-impulse test, oVEMPS, cVEMPS, stabilometry
- •Hematological tests: complete blood count, ESR, PCR, creatininemia, CMV IgM, EBV IgM, ANA, glycemia, study of predisposing genetic factors
结局指标
主要结局
Evaluation of inner ear structures in MRI images
时间窗: 1 day
MRI - ocular and cervical VEMPS - audiological and otoneurological evaluation
次要结局
未报告次要终点
研究者
研究点 (1)
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