EUCTR2020-002329-27-DK
进行中（未招募）
1 期
Improving cerebral blood flow and cognition in patient with cerebral small vessel disease. The ETLAS-2 Trial.
Herlev Gentofte Hospital0 个研究点目标入组 100 人2020年5月25日
适应症Cerebral small vessel disease and stroke.MedDRA version: 21.1Level: LLTClassification code 10070879Term: Cerebral small vessel ischemic diseaseSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 22.1Level: PTClassification code 10076994Term: Lacunar strokeSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
相关药物Tadalafil Stada
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Cerebral small vessel disease and stroke.
- 发起方
- Herlev Gentofte Hospital
- 入组人数
- 100
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\.MRI/computed tomography (CT) evidence of small vessel occlusion stroke(s)/lacunar stroke(s) (involving \=2 cm in the acute phase and \=1\.5cm in the late phase) and/or confluent deep white matter hyperintensities (\= grade 2 on Fazekas’s scale).
- •2\.Clinical evidence of cerebral small vessel disease can be: a) small vessel occlusion stroke (lacunar stroke) syndrome with symptoms lasting \> 24 hours, occurring \< 5 years ago; OR b) transient ischemic attack (TIA) with symptoms lasting \< 24 hours AND with MR\-DWI imaging performed acutely showing small vessel occlusion stroke, occurring \< 5 years ago; OR c) TIA with symptoms lasting \< 24 hours AND no acute MRI\-DWI lesion but MRI/CT evidence of CSVD with old small vessel occlusion stroke(s) (involving \=1\.5cm) and/or confluent deep white matter hyperintensities (\= grade 2 on Fazekas’s scale).
- •3\.Age \= 50 years.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 40
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 60
排除标准
- •1\.Known diagnosis of dementia, medical treated dementia, or under investigaton for dementia
- •2\.Pregnancy or nursing
- •3\.Women of childbearing age not taking contraception
- •4\.Known cortical infarction (\> 1\.5 cm maximum diameter)
- •5\.Known carotid artery stenosis \= 50 % with Doppler ultrasound, CT angiography, or MRI angiography diagnosed within the last five years
- •6\.Known carotid or vertebral dissection as a cause of stroke
- •7\.Stroke after carotid or heart surgery
- •8\.Known hypercoagulable disease
- •9\.Systolic BP \< 90 and/or diastolic BP \< 50
- •10\.Known severe renal impairment (eGFR \< 30ml/min)
结局指标
主要结局
未指定
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