ISRCTN10514229已完成未知
Imaging NeuroVascular, Endothelial and STructural Integrity in prepAration to TrEat Small Vessel Diseases
Academic and Clinical Central Office for Research and Development (ACCORD)0 个研究点目标入组 78 人开始时间: 2016年5月23日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 78
研究概览
简要总结
2021 Protocol article in https://doi.org/10.1016/j.cccb.2021.100020 (added 16/08/2022) 2021 Abstract results in https://doi.org/10.1177/23969873211034932 (added 05/06/2024)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Age 18 years or older
- •2. Able to undergo MRI
- •3. Capacity to give written informed consent
- •4. Symptomatic SVD defined as:
- •4.1. A history of clinical lacunar stroke syndrome in the last 5 years with a recent small subcortical infarct visible on MRI scan or CT scan* compatible with the clinical syndrome.
- •4.2. A diagnosis of CADASIL established by molecular genetic testing of the NOTCH3 gene (presence of an archetypical, cysteine-affecting mutation) or the presence of granular osmiophilic material (GOM) in ultrastructural, electron microscopy analysis of skin biopsy
- •*On MRI, a recent infarct is defined as a DWI lesion on the acute MRI scan. On CT, recent infarct is defined as a novel lacune on CT within 3 weeks after the event that was not visible on the admission CT.
- •or cognitive impairment defined as visiting a memory clinic and a clinical dementia rating [CDR] score of = 0.5, and capacity to consent with confluent deep white matter hyperintensities (WMH) on MRI (defined on the Fazekas scale as deep WMH score = 2)
排除标准
- •1. Inclusion criteria are not met
- •2. Unwillingness or inability to give written consent
- •3. Pregnant or breastfeeding women, women of childbearing age not taking contraception.
- •4. Acceptable contraception in women of childbearing age is a highly effective” contraceptive measure as defined by the Clinical Trials Facilitation Group (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf) and includes combined (oestrogen and progesterone containing) or progesterone-only contraception associated with inhibition of ovulation, or intrauterine device or bilateral tubal occlusion
- •5. Contraindications to MRI (pacemaker, aneurysm clip, cochlear implant etc.)
- •6. Contraindications to gadolinium contrast agent used for MRI
- •7. Other major neurological or psychiatric conditions affecting the brain and interfering with the study design (e.g. multiple sclerosis)
- •8. In case of clinical lacunar stroke syndrome other causes of stroke such as:
- •8.1. =50% luminal stenosis (NASCET) in large arteries supplying the area of ischaemia
- •8.2. Major-risk cardioembolic source of embolism (permanent or paroxysmal atrial fibrillation, sustained atrial flutter, intracardiac thrombus, prosthetic cardiac valve, atrial myxoma or other cardiac tumours, mitral stenosis, recent (<4 weeks) myocardial infarction, left ventricular ejection fraction less than 30%, valvular vegetations, or infective endocarditis)
- •8.3. Other specific causes of stroke identified (e.g. arteritis, dissection, migraine/vasospasm, drug misuse)
- •9. Other stroke risk factor requiring immediate intervention that would preclude involvement in the study
- •10. Renal impairment (eGFR <30 ml/min)
研究者
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