NL-OMON54038招募中不适用
Microvascular rarefaction in vascular cognitive impairment and heart failure -VCI - CRUCIAL-VCI
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 115 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 115
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
- •Inclusion criteria for VCI:
- •VCI due to cSVD defined as:
- •o visiting a memory clinic or outpatient clinic Neurology;
- •o cognitive complaints;
- •o demonstration of a cognitive deficit: MoCA less than 26 or impairment in at
- •least 1 cognitive
- •domain in neuropsychological assessment
- •o imaging evidence of cerebral small vessel disease:
- •- extensive leukoaraiosis on CT, or
- •- (early) confluent WMH on MRI (Fazekas score >= 2), or
- •* - multiple punctate WMH on MRI in combination with lacunar infarcts or
- •microbleeds.
- •o Age 18 years or older
- •o Ability to undergo MRI
- •o Capacity to give written informed consent
- •o Clinical dementia rating scale <=1
- •Inclusion criteria for patients at risk for VCI:
- •Symptomatic cSVD, defined as:
- •o A history of a clinical lacunar stroke with a compatible lesion on CT or MRI
- •(inclusion only > 3 months after stroke onset to avoid acute stroke effects)
- •o Additional imaging evidence of cerebral small vessel disease:
- •* extensive leukoaraiosis on CT, or
- •* (early) confluent WMH on MRI (Fazekas score >= 2), or
- •* Lacunar infarct in combination with multiple punctate WMH on MRI (Fazekas 1)
- •or microbleeds.
- •Age 18 years or older
- •Ability to undergo MRI
- •Capacity to give written informed consent
- •The controls are defined as:
- •- persons visiting the outpatient clinic Neurology
- •- complaints of the peripheral nervous system due to a.o. chronic
- •polyneuropathy, ulnaropathy or carpal tunnel syndrome
- •- no cognitive complaints and/or symptoms
- •- age over 18 years
- •- Ability to undergo MRI
- •- Capacity to give written informed consent
排除标准
- •Exclusion criteria for both VCI and controls
- •Inclusion criteria are not met
- •Unwillingness or inability to give written consent
- •mentally incompetent (or reasonable doubt about competence) to give informed
- •Contraindications to MRI, among which: pacemaker, metallic foreign body,
- •claustrophobia, pregnancy, neurostimulator, other kinds of implanted devices or
- •insulin pump
- •Contraindications to gadolinium contrast agent used for MRI, among which
- •allergy or severe renal impairment (eGFR <30 ml/min)
- •Other major neurological or psychiatric conditions affecting the brain and
- •interfering with the study design, among which: multiple sclerosis, Parkinson*s
- •disease, alcohol/drug abuse, major cortical stroke, major neuro-trauma, brain
- •Exclusion criteria for cardiac MRI (VCI only)
- •Asthma and/or COPD
- •Slow heart rhythm (<50 beats per minute)
- •AV-block II-III
- •Sick sinus syndrome
- •Prolonged QT-interval
- •Hypotension defined as systolic blood pressure less than 90 mmHg
- •Decompensatio cordis
- •Exclusion criterium for fundus imaging only (VCI group)
研究者
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