Data Sheet 1_Efficacy of endovascular treatment for patients with acute large vessel occlusion stroke from the Western Sichuan Plateau and machine learning prediction models: a prospective study protocol.pdf

ObjectivesStroke is the second leading cause of death and the third leading cause of disability among non-communicable diseases globally. The prevalence, incidence, and mortality rates of stroke are higher in high-altitude regions compared to lowland areas. However, compared to plain areas, the efficacy of endovascular therapy for large vessel occlusive acute ischemic stroke (LVO-AIS) in high-altitude regions remains unclear.
Methods and DesignThis study is a multicenter, prospective, endpoint-blinded cohort study. From January 2025 to December 2027, a total of 1,052 patients with acute large vessel occlusion ischemic stroke (LVO-AIS) from the Western Sichuan Plateau will be prospectively enrolled, including those who receive endovascular treatment and those who do not. Baseline characteristics and endovascular treatment details will be documented. Treatment decisions are guided by clinical practice guidelines, taking into account high-altitude real-world constraints such as patient or proxy refusal and delays in interhospital transfer. Medical records will be established for each patient, and a 180-day follow-up will be conducted. The primary outcome was the proportion of patients achieving functional independence [modified Rankin scale (mRS) range from 0 to 2] at 90 days. The secondary outcomes included the mRS score at 90 days, early neurological improvement rate [defined as a National Institutes of Health Stroke Scale (NIHSS) score of 0–2 or a reduction of ≥8 points from baseline within 24 h of enrollment], changes in NIHSS scores between day 7 ± 1 or discharge and baseline, quality of life as assessed by the five-level EuroQol five-dimensional questionnaire at 90 days, and cognitive function at 180 days will be assessed using mini-mental state examination and montreal cognitive assessment scores. Imaging outcomes will include the rate of successful reperfusion (defined as a modified Thrombolysis in Cerebral Infarction score ≥2b) and infarct volume measured within 5–7 days. Statistical analysis and fused optimized multimodal learning were blinded to the group assignments.
ConclusionThis study aims to evaluate the efficacy of endovascular treatment compared with standard medical therapy in patients with LVO-AIS in the Western Sichuan Plateau and to develop an artificial intelligence–based prognostic model to refine treatment strategies for this and other high-altitude regions.
Clinical trial registrationhttps://www.chictr.org.cn/showproj.html?proj=241870, ChiCTR2400092762.

研究背景
卒中是全球范围内非传染性疾病中的第二大死亡原因、第三大致残病因。相较于平原地区，高海拔区域的卒中患病率、发病率及死亡率均更高。但目前针对高海拔地区大血管闭塞性急性缺血性卒中（large vessel occlusive acute ischemic stroke, LVO-AIS）患者，其血管内治疗的疗效与平原地区相比仍不明确。

研究方法与设计
本研究为多中心、前瞻性、终点设盲的队列研究。2025年1月至2027年12月，我们将前瞻性纳入川西高原地区共1052例急性大血管闭塞性缺血性卒中（LVO-AIS）患者，涵盖接受血管内治疗与未接受该治疗的人群。研究将记录患者的基线特征及血管内治疗的详细信息。治疗决策以临床实践指南为指导，同时兼顾高海拔地区的真实世界限制因素，例如患者或其委托代理人拒绝治疗、院间转运延迟等。将为每位患者建立专属病历档案，并开展为期180天的随访。
主要结局指标为患者在发病后90天达到功能独立的比例，即改良Rankin量表（modified Rankin scale, mRS）评分0~2分的患者占比。次要结局指标包括：90天mRS评分、早期神经功能改善率（定义为入院后24小时内美国国立卫生研究院卒中量表（National Institutes of Health Stroke Scale, NIHSS）评分降至0~2分，或较基线评分降低≥8分）、发病后第7±1天或出院时与基线的NIHSS评分变化、90天时采用五维度欧洲五维健康量表（five-level EuroQol five-dimensional questionnaire, EQ-5D-5L）评估的生活质量，以及180天时分别采用简易精神状态检查（mini-mental state examination, MMSE）与蒙特利尔认知评估（montreal cognitive assessment, MoCA）评分评估的认知功能。影像学结局指标包括成功再灌注率（定义为改良脑梗死溶栓量表（modified Thrombolysis in Cerebral Infarction, mTICI）评分≥2b）及发病后5~7天内测量的梗死体积。统计分析与融合优化多模态学习流程将对分组信息进行设盲处理。

研究结论
本研究旨在评估川西高原地区LVO-AIS患者接受血管内治疗相较于标准药物治疗的疗效，并开发基于人工智能的预后模型，以优化该地区及其他高海拔地区的卒中治疗策略。

临床试验注册
https://www.chictr.org.cn/showproj.html?proj=241870，ChiCTR2400092762。