The Adult Hemorrhagic Moyamoya Surgery Study
试验速览
- 阶段
- 3 期
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- All strokes & death within 30 days post-surgery and ipsilateral recurrent bleeding afterwards
研究概览
简要总结
The aim of this study is to investigate whether extracranial-intracranial(EC-IC) bypass surgery could prevent rebleeding and improve neurological function in adult moyamoya with hemorrhagic onset.
详细描述
About one half of adult moyamoya patients present with hemorrhagic onset.As the bleeding events are potentially fatal, it often lead to particularly poor prognosis.However, the natural history is still poorly understood.Although the rebleeding rate is known to be extremely high,no effective therapeutic method has been established based on a worldwide consensus.
The recently published Japanese Adult Moyamoya(JAM) Trial, which is the first prospective,randomized,controlled trial focused on hemorrhagic moyamoya,showed that direct bypass surgery could reduce the rebleeding rate and improve the prognosis.However,the result was statistically marginal with a small sample size and most importantly,it failed to assess the neurological function.The effect of bypass surgery on functional outcome was uncertain.
Therefore,the AHMSS study in China is designed to compare the efficacy and safety of EC-IC bypass surgery with conservative treatment in adult moyamoya patients with hemorrhagic onset by comprehensive assessment of rebleeding rate, neurological function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Independent in activity of daily living(The modified Rankin Scale 0-2)
- •At least one month since the most recent hemorrhagic stroke
- •The neurological deficit must be stable for more than 6 weeks
- •Bleeding in ventricle,cortex,basal ganglia,thalamus and subarachnoid space confirmed by computed tomography plain scan
- •Digital substraction angiography demonstrating progressive stenosis or occlusion in the terminal portion of the internal carotid artery and/or the initial portion of the anterior or middle cerebral arteries
- •Digital substraction angiography demonstrating formation of abnormal collateral networks(moyamoya vessels) at the base of the brain,mainly in the region of thalamus and basal ganglia
- •Digital substraction angiography demonstrating the vasculopathy appeared unilaterally or bilaterally
- •Competent to give informed consent
- •Accessible and reliable for follow-up
排除标准
- •Other cerebrovascular diseases(such as intracranial aneurysm or brain arteriovenous malformation) probably causing intracranial hemorrhage
- •Not independent in activity of daily living(The modified Rankin Scale 3-5)
- •Moyamoya syndrome concomitant with other hereditary or autoimmune diseases(Grave's Disease,Type I Diabetes Mellitus,Type I Neurofibromatosis et al)
- •Moyamoya disease with ruptured aneurysms located in the main stem of Willis' Circle
- •Emergent evacuation of intracerebral hematoma damaging superficial temporal artery or cortical artery
- •Emergent decompressive craniotomy causing automatically developed indirect revascularization
- •Good collateral networks formed by spontaneous anastomosis between extracranial and intracranial vessels before surgery
- •Life expectancy<1 years
- •Unstable angina or myocardial infarction with recent 6 months
- •Blood coagulation dysfunction
- •Allergic to iodine contrast agent
- •Abnormal liver function(alanine transaminase(ALT) and/or aspartate aminotransferase(AST)>3 times of normal range)
- •Serum creatinine >3mg/dl
- •Poorly controlled hypertension(systolic BP>160 mmHg,diastolic BP>100 mmHg)
- •Poor glucose control(fasting blood glucose>16.7mmol/l)
- •Concurrent participation in any other interventional clinical trial
结局指标
主要结局
All strokes & death within 30 days post-surgery and ipsilateral recurrent bleeding afterwards
时间窗: within 5 years of randomization
The number of participants who suffer from all strokes \& death within 30 days post-surgery and ipsilateral recurrent bleeding afterwards within 5 years of randomization
次要结局
- The changes from baseline in modified Rankin Scale (mRS)(at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial)
- The changes from baseline in modified Barthel Index(at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial)
- Rebleeding on the contralateral side(up to 5 years)
- The changes from baseline in National Institute of Health Stroke Scale (NIHSS)(at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial)
- All kinds of adverse events related to surgery(up to 30 days)
- Transient ischemic attack on the surgically treated side(up to 5 years)