Telemedicine-supported Management for Acute Ischemic Stroke

Официальное название

Telemedicine-supported Management of Acute Ischemic Stroke in the Basic-level Hospitals

Обзор

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.

Вмешательства

• Другое Telemedicine-Supported Management
  Receive round-the-clock 7×24h remote consultation guidance from expert teams at leading stroke centers, covering patient triage and initial assessment, thrombolysis decision-making, and treatment guidance. Undergo quality control for standardized workflow implementation, and professional training.

Первичные конечные точки

• Proportion of patients with mRS scores of 0-1 [Срок оценки: 90 days]

Вторичные конечные точки (4)

• Intravenous thrombolysis rate [Срок оценки: 4.5 hours]
• mRS score [Срок оценки: 90 days]
• Door-to-(thrombolysis)needle-time [Срок оценки: 4.5 hours]
• Rate of endovascular therapy receipt among eligible patients [Срок оценки: 24 hours]

Критерии участия

Критерии включения

• 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 ≤1.
• Informed consent obtained from patient or their legal representative.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xuanwu Hospital — Пекин

Идентификаторы

NCT: NCT07302971 · TOGETHER

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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