Diagnostic and Prognostic Biomarkers of Idiopathic Intracranial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Biomarkers of IIH (diagnostic and prognostic)
研究概览
简要总结
Idiopathic intracranial hypertension (IIH) is a condition of unknown etiology, primarily affecting overweight females of childbearing age. Typically, patients experience headache and visual symptoms due to increased intracranial pressure (ICP) and papilledema. The diagnosis is difficult, and outcomes vary from no sequelae to blindness or chronic headaches. No clear prognostic indicators exist. Treatment consists of medication, weight loss, and possibly surgical intervention.There is an unmet need of defining biomarkers with prognostic or diagnostic value and defining predictors of a poor outcome.
This project is a prospective, population-based cohort study including clinical data and a biobank (blood samples and cerebrospinal fluid).
The investigator's primary aim is to identify biomarkers of diagnostic or prognostic value and to create a clinical IIH database. The clinical database will answer questions about patient characteristics at baseline and during follow-up, identify predictors of outcome, and help create a standardized programme for follow-up and
详细描述
This study is a multicenter, prospective, population-based cohort study with consecutive inclusion of patients in which the diagnosis of IIH is suspected. This study is carried out in collaboration between the Danish Headache Center, Rigshospitalet-Glostrup, and the Neurological Department at Odense University Hospital.
Patients are eligible for inclusion into the study if:
- IIH is suspected
- > 18 years old and able to provide written informed consent.
At baseline included patients will have:
A.) Medical history B.) Neurological, ophthalmological and general medical examination C.) Relevant neuro-imaging D.) Blood samples and lumbar puncture F.) Evaluation by other specialist, including neuro-psychologists, if appropriate.
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
- •Able to and willing to provide informed consent
- •More than 18 years of age
- •Suspicion of IIH (based on clinical evaluation by neurologist or opthalmologist)
排除标准
- •1.) Unable to consent (e.g. language, mental retardation).
结局指标
主要结局
Biomarkers of IIH (diagnostic and prognostic)
时间窗: 2 years
Analyses of CSF and blood for markers of metabolism (method: Metabolomics)
Headache status at conclusion of study
时间窗: 2 years
Prevalence of chronic headache (\>=15 headache days per month)
Visual status at conclusion of study
时间窗: 2 years
Assessment of visual acuity
次要结局
- Baseline characteristics related to IIH diagnosis(2 years)
- Development of IIH or IIHWOP in patients with borderline elevated ICP not fulfilling diagnostic criteria at baseline(2 years)
- Baseline characteristics related to poor outcome(1 year)
- Results of neuropsychological evaluations(1 year)
- Clinical markers related to disease activity(2 years)
- Treatment and follow-up(3 years)
- Weight change in a standard care program(2 years)
- Diagnostic criteria and their use in the clinical setting(2 years)
研究者
Johanne Severinsen
Clinical assistant, M.D.
Danish Headache Center