NL-OMON51836招募中不适用
INflammation and cerebral small vessel disease (INSVD) study - INSVD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patient population
- •1. Have given written informed consent to participate
- •2. Be aged 40 years and over
- •3. Have symptomatic cerebral small vessel disease defined as:
- •Clinically symptomatic lacunar infarct in presence of white matter
- •hyperintensities (Fazekas >=1) on MRI
- •and/or symptoms of cognitive impairment due to small vessel disease (Fazekas
- •>= 1) with lacunar infarct on MRI
- •and/or gait apraxia/motor impairment presumed due to small vessel disease
- •(Fazekas >= 1) with lacunar infarct on MRI
- •If there is a recent history of stroke, baseline MRI will be scheduled at least
- •3 months after last stroke to exclude BBB changes secondary to acute infarction.
- •Healthy control population
- •1. Have given written informed consent to participate
- •2. Be aged 40 years and over
排除标准
- •Patient population
- •- unable/unwilling to consent including lack of capacity to consent
- •- vaccination or infection with fever in preceding month
- •- any stroke cause other than SVD including:
- •o Cardioembolic source
- •o Carotid or vertebral stenosis >50% measured on NASCET criteria
- •- Myocardial infarction in past year
- •- Vasculitis
- •- any chronic disease that could lead to brain lesions mimicking SVD (for
- •example multiple sclerosis)
- •- contraindications for 3 T MRI
- •- auto-immune/auto-inflammatory disease
- •- use of immunomodulating drugs
- •- Estimated glomerular filtration rate (eGFR) <= 29 ml/min/1.73m2. eGFR needs
- •to have been measured within the past 3 months in case the last measurement
- •was <45ml/min/1.73m2, or within the past 13 months in all other cases.
- •- Another diagnosed chronic neurological condition (e.g. Alzheimer's,
- •Parkinson's disease, motor neurone disease, multiple sclerosis).
- •- Limited life expectancy due to another illness or chronic condition making
- •the 2 year follow-up difficult (e.g. widespread malignancy).
- •Healthy control population
- •- Unable/unwilling to consent including lack of capacity to consent
- •- Contraindications for 3 T MRI
- •- Vaccination or infection with fever in preceding month
- •- Any stroke or SVD pathology or symptoms (some white matter hyperintensities
- •are permitted)
- •- Another diagnosed chronic neurological condition (e.g. Alzheimer's,
- •Parkinson's disease, motor neurone disease, multiple sclerosis)
- •- Myocardial infarction in past year
- •- Auto-immune/auto-inflammatory disease
- •- Use of immunomodulating drugs
- •- Estimated glomerular filtration rate (eGFR) <= 29 ml/min/1.73m2. eGFR needs
- •to have been measured within the past 3 months in case the last measurement
- •was <45ml/min/1.73m2, or within the past 13 months in all other cases.
研究者
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