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 人开始时间: 2020年5月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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)
- •11.Known severe hepatic impairment (Child-Pugh > B)
- •12.History of non-arthritic anterior ischemic optic neuropathy
- •13.Concomitant use of PDE5 inhibitors e.g. sildenafil, tadalafil, and vardenafil during trial period
- •14.Patients receiving nicorandil and nitrates e.g. isosorbide mononitrate, isosorbide dinitrate, glyceryl trinitrate
- •15.History of acute myocardial infarction in the last three months before trial intervention
- •16.Body weight > 130kg
- •17.Known cardiac failure (NYHA = II)
- •18.Known persistent or paroxysmal atrial fibrillation/flutter
- •19.History of sick sinus syndrome” or other supraventricular cardiac conduction conditions such as sinoatrial or atrioventricular block (2nd of 3rd degree)
- •20.Other known cardiogenic cause of stroke
- •21.Contraindication to CO2 challage, eg severe respiratory disease
- •22.MRI not tolerated or contraindicated
- •23.Known monogenic causes of stroke i.e. CADASIL
- •24.Unable to provide informed consent
- •25.The participant does not wish to be informed about results from the MRI
研究者
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