NL-OMON28554尚未招募不适用
MiCRovascular rarefaction in vascUlar Cognitive Impairment and heArt failure - VCI
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 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
入选标准
- •Inclusion criteria for VCI
- •VCI due to cSVD defined as:
- •ovisiting a memory clinic or outpatient clinic Neurology;
- •ocognitive complaints;
- •odemonstration of a cognitive deficit: MoCA<26 or impairment in at least 1 cognitive domain in neuropsychological assessment
- •oimaging 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 (Fazekas 1) in combination with lacunar infarcts or microbleeds.
- •oAge 18 years or older
- •oAbility to undergo MRI
- •oCapacity to give written informed consent
- •oClinical dementia rating scale =1
- •Inclusion criteria for controls
- •visiting the outpatient clinic Neurology with complaints related to the peripheral nervous system (e.g. chronic polyneuropathy, carpal tunnel syndrome or neurogenic claudicatio intermittens).
- •No cognitive complaints
- •No objective cognitive deficit
- •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
- •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 tumors.
- •Exclusion criteria for cardiac MRI (VCI only)
- •Asthma and/or COPD
- •Slow heart rhythm (<50 beats per minute)
- •Irregular heart rhythm (i.e. atrial fibrillation)
- •AV-block II-III
- •Sick sinus syndrome
- •Prolonged QT-interval
- •Hypotension defined as systolic blood pressure less than 90 mmHg
- •Decompensatio cordis
研究者
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