NCT07302971

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,400

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Feb 2026Dec 2027

First Submitted

Initial submission to the registry

December 2, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 3, 2026

Status Verified

November 1, 2025

Enrollment Period

1.3 years

First QC Date

December 2, 2025

Last Update Submit

February 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with mRS scores of 0-1

    90 days

Secondary Outcomes (4)

  • 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

Other Outcomes (3)

  • Proportion of sICH

    Within 36 hours of thrombolysis

  • Proportion of any type of ICH

    Within 36 hours of thrombolysis

  • All-cause mortality rate

    90 days

Study Arms (2)

Telemedicine-Supported Group

EXPERIMENTAL

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

Standard Treatment Group without Telemedicine-Supported Management

NO INTERVENTION

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.

Interventions

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.

Telemedicine-Supported Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • Admitting fewer than 10 patients with acute ischemic stroke per month.
  • Currently participating in other clinical trials that may interfere with this trial.
  • Presence of contraindications for intravenous thrombolysis according to AHA/ASA guidelines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology, Xuanwu Hospital, Capital Medical University

Study Record Dates

First Submitted

December 2, 2025

First Posted

December 24, 2025

Study Start

February 2, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 3, 2026

Record last verified: 2025-11

Locations