Telemedicine-supported Management of Acute Ischemic Stroke in the Basic-level Hospitals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- Proportion of patients with mRS scores of 0-1
研究概览
简要总结
Telemedicine-supported stroke care can provide standardized guidance to hospitals and regions with limited medical resources, thereby improving treatment outcomes for stroke patients in these areas. While this approach has been widely adopted in many developed countries, its efficacy in guiding basic-level hospitals to manage acute ischemic stroke requires further investigation through large-scale, high-quality studies.
This study focused on patients with acute ischemic stroke who sought treatment at basic-level hospitals, aiming to investigate the efficacy and safety of treating acute ischemic stroke with telemedicine-supported management. Hospitals assigned to the experimental group received remote consultation guidance, quality control and professional training from expert teams at leading stroke centers, China National Center for Neurological Disorders. Hospitals in the control group did not receive telemedicine-supported management.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospital Inclusion Criteria:
- •Basic-level hospitals in China (Definition: Hospitals classified as secondary-level (Grade II) or below under China's Hospital Grading Management Standards, or hospitals located in counties/county-level cities).
- •Equipped with an emergency department and neurology ward capable of admitting stroke patients.
- •Equipped with CT and/or MRI capable of diagnosing AIS.
- •Equipped with intravenous thrombolytic drugs for acute ischemic stroke.
- •Patient Inclusion Criteria:
- •Age ≥ 18 years.
- •Diagnosed with acute ischemic stroke.
- •CT/MRI confirms absence of intracerebral hemorrhage.
- •Onset of stroke symptoms ≤ 4.5 hours.
- •pre-stroke mRS score ≤
- •Informed consent obtained from patient or their legal representative.
排除标准
- •Hospital Exclusion Criteria:
- •Admitting fewer than 10 patients with acute ischemic stroke per month.
- •Currently participating in other clinical trials that may interfere with this trial.
- •Patient Exclusion Criteria:
- •Presence of contraindications for intravenous thrombolysis according to AHA/ASA guidelines
研究组 & 干预措施
Telemedicine-Supported Group
Receive remote guidance from expert stroke centers for treatment of patients with intravenous thrombolysis, along with quality control for standardized workflow support, and professional training.
干预措施: Telemedicine-Supported Management (Other)
Standard Treatment Group without Telemedicine-Supported Management
Control-group patients will receive routine stroke care at their primary care hospitals, with no remote consultation, study-related quality control, or extra training. Care will follow the hospitals' usual protocols, including emergency assessment, neurological evaluation, imaging, and intravenous thrombolysis. Hospitals may continue their regular stroke-related training during the study to reflect real-world practice.
结局指标
主要结局
Proportion of patients with mRS scores of 0-1
时间窗: 90 days
次要结局
- Intravenous thrombolysis rate(4.5 hours)
- mRS score(90 days)
- Door-to-(thrombolysis)needle-time(4.5 hours)
- Rate of endovascular therapy receipt among eligible patients(24 hours)
研究者
Ji Xunming,MD,PhD
Professor of Neurology, Xuanwu Hospital, Capital Medical University
Capital Medical University