Telemedicine-supported Management for Acute Ischemic Stroke (TOGETHER)

Capital Medical University

Status: Enrolling

Conditions: Acute Ischemic Stroke

Treatments: Other: Telemedicine-Supported Management

Study type: Interventional

Funder types: Other

Identifiers

NCT07302971

TOGETHER

Details and patient eligibility

About

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.

Enrollment: 2,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hospital Inclusion Criteria:

  1. 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).
  2. Equipped with an emergency department and neurology ward capable of admitting stroke patients.
  3. Equipped with CT and/or MRI capable of diagnosing AIS.
  4. Equipped with intravenous thrombolytic drugs for acute ischemic stroke.

• Patient Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Diagnosed with acute ischemic stroke.
  3. CT/MRI confirms absence of intracerebral hemorrhage.
  4. Onset of stroke symptoms ≤ 4.5 hours.
  5. pre-stroke mRS score ≤1.
  6. Informed consent obtained from patient or their legal representative.

Exclusion criteria

• Hospital Exclusion Criteria:

  1. Admitting fewer than 10 patients with acute ischemic stroke per month.
  2. Currently participating in other clinical trials that may interfere with this trial.

• Patient Exclusion Criteria:

  1. Presence of contraindications for intravenous thrombolysis according to AHA/ASA guidelines

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,400 participants in 2 patient groups

Telemedicine-Supported Group

Experimental group

Description:

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.

Treatment:

Other: Telemedicine-Supported Management

Standard Treatment Group without Telemedicine-Supported Management

No Intervention group

Description:

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.