背景:作为亚洲人缺血性卒中的一种有意义的亚型,分支动脉粥样硬化病(BAD)相关的卒中与高早期神经功能恶化(END)和残疾有关,但研究不足,没有推荐的治疗方法。END的机制尚不清楚。因此,分支动脉粥样硬化疾病相关卒中研究(BAD研究)旨在调查人口统计学,临床和放射学特征,中国患者BAD相关卒中的预后。
方法:糟糕的研究是全国性的,多中心,连续的,prospective,观察性队列研究纳入18-80岁的BAD相关卒中患者在症状发作后72小时内。初始临床数据,实验室测试,影像学数据通过结构化病例报告表收集,随访将在7天进行,30天,90天,入学后6个月和12个月。主要结果是90天随访和单盲评估的改良Rankin量表评分。次要结果包括7天内的END,和美国国立卫生研究院卒中量表评分,Barthel指数,脑血管事件,主要出血并发症,以及90天随访期间的全因死亡率。将通过高分辨率磁共振成像结合其他成像技术来评估穿透性和母体动脉的特征。
结论:BAD研究可以提供人口统计,临床,放射学,和BAD相关卒中的预后特征,从而潜在地找出早期神经恶化的血管机制,并借助先进的成像技术优化治疗策略。未来还将为BAD相关卒中的随机对照试验提供基线数据和证据。
BACKGROUND: As a meaningful subtype of ischemic stroke in Asians, Branch atheromatous disease (BAD)-related stroke is associated with high early neurological deterioration (END) and disability, but is understudied and without recommended therapy. The mechanism of END still remains unclear. Branch atheromatous disease-related stroke
study (BAD-
study) therefore aims to investigate demographic, clinical and radiological features, and prognosis of BAD-related stroke in Chinese patients.
METHODS: BAD-
study is a nationwide, multicenter, consecutive, prospective, observational cohort
study enrolling patients aged 18-80 years with BAD-related stroke within 72 h after symptom onset. Initial clinical data, laboratory tests, and imaging data are collected via structured case report form, and follow-ups will be performed at 7 days, 30 days, 90 days, 6 months and 12 months after enrollment. The primary outcome is the score on modified Rankin Scale at 90-day follow-up with single-blinded assessment. Secondary outcomes include END within 7 days, and National institute of health stroke scale score, Barthel index, cerebrovascular events, major bleeding complications, and all-cause mortality during 90-day follow-up. Characteristics of penetrating and parent artery will be assessed by high-resolution magnetic resonance imaging combined with other imaging techniques.
CONCLUSIONS: BAD-
study can provide demographic, clinical, radiological, and prognostic characteristics of BAD-related stroke, and thereby potentially figure out the vascular mechanism of early neurological deterioration and optimize therapy strategy with the aid of advanced imaging technique. Baseline data and evidence will also be generated for randomized controlled trials on BAD-related stroke in the future.