Telemedicine-supported Management for Acute Ischemic Stroke (TOGETHER)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Other: Telemedicine-Supported Management

• Study Type: Interventional
• Enrollment (Estimated): 2400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xunming Ji; Phone Number: 01083198962; Email: jixm@ccmu.edu.cn
• Study Contact Backup: Name: Chuanjie Wu; Phone Number: 01083199439; Email: wuchuanjie@ccmu.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100053
      • Recruiting
      • Xuanwu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with mRS scores of 0-1	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intravenous thrombolysis rate		4.5 hours
mRS score	Ranges from 0 to 6 points, with lower scores indicating better functional outcome.	90 days
Door-to-(thrombolysis)needle-time	The time calculation begins when the patient arrives at the hospital and ends upon receiving thrombolytic therapy. The theoretical range is 0 to 270 minutes.	4.5 hours
Rate of endovascular therapy receipt among eligible patients		24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of sICH	The time frame is within 36 hours after thrombolysis in patients. Symptomatic intracranial hemorrhage occurring during this period is considered an endpoint event. If the patient is discharged within 36 hours, the endpoint event is observed during the hospitalization period.	Within 36 hours of thrombolysis
Proportion of any type of ICH	The time frame is within 36 hours of thrombolysis administration. Any type of intracerebral hemorrhage occurring during this period is considered an endpoint event. If the patient is discharged within 36 hours, the endpoint event is observed during the hospitalization period.	Within 36 hours of thrombolysis
All-cause mortality rate		90 days

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: TOGETHER

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No