Telemedicine-supported Management for Acute Ischemic Stroke (TOGETHER)

February 2, 2026 updated by: Ji Xunming,MD,PhD, Capital Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of patients with mRS scores of 0-1
Time Frame: 90 days
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intravenous thrombolysis rate
Time Frame: 4.5 hours
4.5 hours
mRS score
Time Frame: 90 days
Ranges from 0 to 6 points, with lower scores indicating better functional outcome.
90 days
Door-to-(thrombolysis)needle-time
Time Frame: 4.5 hours
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
Time Frame: 24 hours
24 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of sICH
Time Frame: Within 36 hours of thrombolysis
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
Time Frame: Within 36 hours of thrombolysis
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
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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