EUCTR2016-002920-10-DE进行中（未招募）1 期
TREAT-SVDs:EffecTs of Amlodipine and other Blood PREssure Lowering Agents on Microvascular FuncTion in Small Vessel Diseases - TREAT-SVDs
Klinikum der Universitaet Muenchen AoeR0 个研究点目标入组 105 人开始时间: 2016年8月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
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
- •Symptomatic SVD defined as
- •oHistory of clinical lacunar stroke in the last 5 years with a corresponding recent small subcortical infarct visible on MRI scan or CT scan compatible with the clinical syndrome. On MRI, recent infarct is defined as a DWI lesion on the acute MRI scan. On CT, recent infarct is defined as a novel infarct on CT within 3 weeks after the event that was not visible on the admission CT. Patients admitted to the hospital with an obvious lacunar syndrome and an admission CT/CT perfusion compatible with a lacunar infarct but without an MRI in the (sub)acute stage and no repeat CT performed in the context of clinical care can be recruited for TREAT-SVDs. After providing informed consent they will be invited for the screening visit including a 3T MRI. The 3T MRI will be used to verify the presence of a new lesion, relative to the admission CT, compatible with a lacunar infarct and compatible with the lacunar syndrome. If such a lesion is present the patient will undergo the further TREAT-SVDs workup. If no such lesion is observed the patient will be excluded from the study and considered as a screening failure.
- •oor cognitive impairment defined as visiting a memory clinic with cognitive complaints, objective cognitive impairment * and capacity to consent, and with confluent deep white matter hyperintensities (WMH) on MRI (defined on the Fazekas scale as deep WMH score = 2) (*concluded by the treating physician based on a validated cognitive measurement tool (for example but not limited to MoCA or CAMCOG))
- •oor 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 in ultrastructural, electron microscopy analysis of skin biopsy
- •Indication for antihypertensive treatment (as defined by meeting one of the following):
- •oHypertension defined as systolic blood pressure (SBP) =140mmHg or diastolic BP (DBP) =90mmHg without antihypertensive treatment or use of an antihypertensive drug for previously diagnosed hypertension
- •oPrior history of stroke or transient ischaemic attack (TIA)
- •Age 18 years or older
- •Written informed consent
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •Unwillingness or inability to give written consent
- •Pregnant or breastfeeding women, women of childbearing age not taking contraception.
- •Acceptable contraception in women of childbearing age is a highly effective” contraceptive measure as defined by the Clinical Trials Facilitation Group
- •Contraindications to MRI (pacemaker, aneurysm clip, cochlear implant etc.)
- •Other major neurological or psychiatric conditions affecting the brain and interfering with the trial design (e.g. multiple sclerosis)
- •In case of clinical lacunar stroke syndrome other causes of stroke such as
- •o=50% luminal stenosis (NASCET) in large arteries supplying the area of ischaemia
- •omajor-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)
- •oother specific causes of stroke identified (e.g. arteritis, dissection, migraine/vasospasm, drug misuse)
- •Other stroke risk factor requiring immediate intervention that would preclude involvement in the trial
- •Renal impairment (eGFR <35ml/min)
- •Life expectancy <2 years
- •Use of >2 antihypertensive drugs at maximum dose or equivalent (one drug at the maximum dose and two drugs at half of the maximum dose) for an appropriate BP control
- •Contraindications to the applied antihypertensive drug
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