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临床试验/NL-OMON28554
NL-OMON28554尚未招募不适用

MiCRovascular rarefaction in vascUlar Cognitive Impairment and heArt failure - VCI

Maastricht University Medical Center0 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
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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